The Nexus of Power, Policy, and Pharmaceuticals: An Analysis of U.S. Healthcare Debates and Industry Dynamics

Executive Summary

• U.S. Drug Pricing: Prescription drug prices in the United States are significantly higher (2.78 times overall, 4.22 times for brand-name drugs before rebates) than in 33 comparable OECD countries, largely due to a fragmented negotiation system. Even after estimated rebates, U.S. brand-name drug prices remain over three times higher. Generic drug prices in the U.S., however, are comparatively lower. (See Section III.A)
• “Most Favored Nation” (MFN) Policy: President Trump’s MFN proposal, aimed at tying U.S. drug prices to the lowest international prices, faced criticism for its feasibility, potential to disrupt global R&D, and uncertain impact on Medicaid. Previous attempts were blocked legally. (See Section III.A)
• Cost of Drug Development: Estimates for bringing a new drug to market vary, with a 2014 Tufts CSDD study citing $2.6 billion (capitalized, including failures and post-approval R&D). A more recent 2025 RAND study found a median capitalized cost of $708 million and a mean of $1.3 billion, suggesting outliers skew the average. (See Section III.A)
• Pricing and Innovation: A contentious debate exists on whether high U.S. drug prices are necessary to fund R&D. Some studies project significant reductions in new drug approvals if U.S. prices are controlled, while others argue current prices exceed R&D needs, citing public funding contributions (e.g., via NIH) and industry spending on non-R&D activities. (See Section III.A)
• Global R&D Burden: The U.S. market contributes significantly to global pharmaceutical revenues, leading to arguments that it disproportionately funds global R&D. However, this is complicated by substantial public investment in basic research and the price negotiation strategies of other developed nations. (See Section III.A)
• Pharmaceutical Business Models: The traditional “blockbuster drug” model (>$1 billion annual sales) remains influential, with companies often focusing R&D on a few high-potential assets. There’s also a trend towards developing targeted therapies for smaller, orphan disease populations. (See Section III.B)
• Patents and Generic Competition: Patents grant market exclusivity (effectively 7-12 years post-approval) to recoup R&D costs. Generic drug entry after patent expiry significantly reduces prices (often 80-90%), saving the healthcare system billions. Practices like “evergreening” to extend exclusivity are criticized. (See Section III.B)
• Orphan Drug Act (ODA): Enacted in 1983, the ODA incentivizes development for rare diseases (affecting <200,000 people in the U.S.) through market exclusivity (7 years), tax credits (currently 25% ), and fee waivers. It has spurred many approvals but faces criticism over high prices of some orphan drugs and potential misuse of incentives. (See Section III.B)   
• FDA Approval Trends: In 2024, the FDA’s CDER approved 50 novel drugs, consistent with recent averages. A significant portion (26 approvals, 52%) were for orphan drugs. The overall likelihood of a drug progressing from Phase I to approval is around 7.9%, with Phase II being the largest hurdle. (See Section III.C)
• FDA Reform Initiatives: PDUFA user fees help fund and expedite FDA reviews. The 21st Century Cures Act promotes the use of Real-World Evidence (RWE) to potentially lower development costs, though its broad adoption has been slow. Initiatives in Advanced Manufacturing and AI/ML are also underway. (See Section III.C)
• Public Trust in Pharmaceuticals: Public trust in the pharmaceutical industry is at a record low (18% positive view, Gallup 2023), influenced by high drug prices, the opioid crisis, and perceived profit-seeking. Younger demographics show particular distrust, often turning to social media for health information. (See Section III.D)
• “The Power and the Money” Framework: Tevi Troy’s book highlights the complex, interdependent, and often contentious relationship between U.S. presidents and industry leaders. This framework is applicable to the pharmaceutical sector, where government wields significant regulatory and purchasing power, and industry engages in extensive lobbying and strategic navigation of Washington. (See Section I.B, Section IV.A)   
• Trump Administration and Pharma: The Trump administration’s interactions with the pharmaceutical industry, including the MFN proposal and rhetoric on drug pricing, illustrate Troy’s themes of presidential influence, corporate strategy, and the use of industries as both allies and foils. (See Section IV.B)
• Future Research Directions: Key areas for future research include the precise elasticity of innovation to price changes, optimal global R&D cost-sharing models, the long-term impact of RWE, effectiveness of PBM regulation, effects of healthcare consolidation, and behavioral economics of patient trust. (See Section V.A)
• Policy Considerations: Potential policy levers include value-based pricing, patent reform to curb anti-competitive practices, targeted R&D incentives for unmet needs, enhancing FDA capacity, promoting supply chain transparency, and fostering international collaboration on pharmaceutical policy. (See Section V.B)
• Enduring Tensions: The report concludes that the pharmaceutical sector is characterized by an ongoing tension between market-driven innovation, public health needs, and political power, requiring a continuous search for a dynamic equilibrium rather than a single, permanent solution. (See Section VI.B)

I. Introduction: Setting the Stage for a Complex Dialogue

A. Contextualizing the Shapiro-Troy Conversation

Discussions surrounding the U.S. healthcare system, particularly the role and conduct of the pharmaceutical industry, are persistent features of the American political and social landscape. These debates often serve as a microcosm for broader ideological contestations regarding the appropriate balance between free-market principles, corporate responsibility, and governmental oversight. Conversations involving commentators like Ben Shapiro and policy experts such as Tevi Troy frequently delve into the complexities of drug pricing, innovation incentives, and the regulatory environment, reflecting deep-seated differences in perspectives on how to achieve a healthcare system that is both innovative and affordable. These dialogues are not merely academic; they echo public anxieties and inform the political discourse that shapes policy. The very nature of these conversations, often polarized, underscores the challenge of finding common ground on issues critical to national well-being.

B. Introducing Tevi Troy’s “The Power and the Money”

A crucial framework for understanding the political and economic forces influencing healthcare policy is provided by Tevi Troy’s book, The Power and the Money: The Epic Clashes Between American Titans of Industry and Commanders in Chief.1 The central thesis of Troy’s work posits an intricate, often contentious, yet undeniably significant relationship between American presidents and the nation’s most influential business leaders. The book unearths “untold stories – both political and personal – that have shaped America,” detailing an “intricate dance between business and politics”.1 Within this dynamic, CEOs and presidents are portrayed as mutually dependent, capable of forging alliances, yet also serving as convenient foils or outright adversaries for one another.1 Troy’s analysis highlights how the expansive reach of the federal government has become a “critical fact of life for every business, entrepreneur, and innovator,” compelling corporate leaders to navigate the corridors of power in Washington.1 This perspective is particularly salient when examining the pharmaceutical industry, a sector characterized by high stakes, significant regulation, and profound public impact. The interactions between government and this industry are not simply transactional policy adjustments but are deeply embedded in historical patterns of power negotiation and influence, often personalized at the highest echelons of leadership.

C. Report Aims and Structure

This report aims to dissect the key themes likely to arise in a discussion between Ben Shapiro and Tevi Troy concerning healthcare and pharmaceutical companies. It will expand upon these themes through a rigorous examination of current research and data, focusing on drug pricing, research and development (R&D) costs, innovation dynamics, regulatory frameworks, and public perception of the pharmaceutical industry. A significant component of this analysis will involve connecting these issues to the overarching themes of Tevi Troy’s “The Power and the Money,” using the Trump administration’s interactions with the pharmaceutical sector as a contemporary illustration. Finally, the report will identify and propose potential avenues for future research to address enduring questions in this critical policy domain. The subsequent sections will delve into specific aspects of this complex interplay, beginning with an assumed analysis of the Shapiro-Troy discourse, followed by an in-depth exploration of U.S. healthcare and pharmaceutical dynamics, an application of Troy’s framework to government-industry relations in this sector, and a forward-looking discussion of research and policy considerations.

The conversation between figures like Shapiro and Troy, while offering specific viewpoints, often reflects broader societal anxieties and political fault lines regarding healthcare affordability and the perceived power of pharmaceutical corporations. Troy’s historical and policy-oriented perspective, as evidenced by his work 1, suggests that government-pharmaceutical industry interactions are not merely about policy details but are rooted in fundamental power dynamics, influence, and mutual dependency, often personalized at the President-CEO level. Understanding these interactions through such a framework moves the analysis beyond simplistic policy debates to a more nuanced appreciation of how power is negotiated and exercised, which has profound implications for healthcare outcomes, costs, and the very fabric of government-business relations.

II. Analyzing the Discourse: Key Points from Shapiro and Troy on Healthcare and Pharmaceuticals

(This section is structured based on anticipated themes, as the specific transcript of the conversation between Ben Shapiro and Tevi Troy was not provided. The analysis below outlines how their discussion would be deconstructed and linked to the report’s broader objectives.)

A. Identified Key Themes from the Conversation

A dialogue between Ben Shapiro and Tevi Troy on healthcare and pharmaceuticals would likely traverse several critical themes. These would predictably include the persistent issue of high prescription drug prices in the United States, the debate over what drives pharmaceutical innovation and the costs associated with it, the role and impact of intermediaries such as Pharmacy Benefit Managers (PBMs), the extent and nature of government regulation versus free-market principles, and the ethical considerations of profit in healthcare. The conversation would also likely touch upon the political dimensions of healthcare reform and the influence of various stakeholders.

B. Ben Shapiro’s Main Arguments/Perspectives

Ben Shapiro’s contributions would likely emphasize free-market solutions to healthcare challenges. Arguments would probably center on the idea that competition, deregulation, and consumer choice are the most effective mechanisms for controlling costs and fostering innovation. Criticisms might be leveled against government intervention, such as price controls or expanded Medicare negotiation, as detrimental to the R&D pipeline. Pharmaceutical company profits might be defended as a necessary reward for the high-risk, high-cost process of drug development.

C. Tevi Troy’s Main Arguments/Perspectives

Drawing on his expertise as a presidential historian and former White House aide, Tevi Troy would likely offer perspectives grounded in historical precedent and the practicalities of policymaking.1 His arguments might focus on the historical interactions between government and industry, perhaps citing examples from his book, “The Power and the Money,” to illustrate the complexities of these relationships. He might analyze the effectiveness of past policy interventions and discuss the balance presidents must strike between fostering business and protecting public interest. His insights would likely illuminate the power dynamics that shape healthcare policy beyond ideological talking points.

D. Areas of Agreement and Disagreement

Points of agreement might emerge on the importance of innovation or the inefficiencies within the current system. However, significant disagreement would be anticipated regarding the causes of problems and the preferred solutions. Shapiro might attribute high costs primarily to regulatory burdens or lack of market competition, while Troy might point to structural issues, market failures, or the complexities of the U.S. system that have evolved over decades of political and corporate maneuvering.

E. Specific Mentions of “The Power and the Money” or its Themes within the Conversation

It is plausible that Tevi Troy would directly reference his book or its core themes, such as the symbiotic yet often conflicting relationship between presidents and CEOs, or the ways in which government power and corporate strategy intersect and clash. These references would serve to ground the specific discussion of healthcare within his broader analytical framework of American political and economic history.

The specific arguments raised by Shapiro and Troy would serve as direct springboards for the deeper, evidence-based analysis in subsequent sections of this report. For instance, any debate concerning the “Most Favored Nation” policy or international price comparisons would be expanded upon with detailed data and expert opinions. Furthermore, the manner in which Shapiro and Troy frame the issues—for example, emphasizing market failures versus government failures, or the role of individual incentives versus systemic factors—would reveal underlying ideological assumptions. These assumptions are critical because they shape how problems are defined and which solutions are deemed viable in the broader public and policy discourse on healthcare. Understanding these frames is essential, as they significantly influence the trajectory of policy debates and the potential for bridging ideological divides on complex issues.

III. Beyond the Conversation: An In-Depth Examination of U.S. Healthcare and Pharmaceutical Dynamics

A. The American Premium: Drug Pricing, R&D, and Global Realities

The United States healthcare system is characterized by a significant premium on prescription drug costs when compared to other developed nations. This disparity, its underlying causes, and its implications for research and development (R&D) and global health equity are central to ongoing policy debates.

1. U.S. Drug Prices in a Global Context: Data and Disparities

Data consistently demonstrate that prescription drug prices in the U.S. are substantially higher than in other high-income countries. A 2024 report by the RAND Corporation, using 2022 data, found that U.S. manufacturer gross prices across all drugs were 2.78 times higher than those in 33 comparable Organisation for Economic Co-operation and Development (OECD) countries.3 This gap is even more pronounced for brand-name originator drugs, where U.S. prices were 4.22 times higher; even after adjusting for estimated U.S. rebates, brand-name drug prices remained 3.22 times higher.4 In contrast, U.S. prices for unbranded generic drugs were found to be, on average, 67% of those in comparison countries, though generics constitute a much larger share of U.S. prescription volume (90%) than spending (8% at gross prices).4 Specific drug examples illustrate these disparities vividly: the weight-loss drug Wegovy costs $1,349 a month in the U.S. versus $328 in Germany, and the cancer treatment Keytruda is priced at $191,000 a year in the U.S. compared to $44,000 in Japan.8

A primary driver of these higher U.S. prices is the fragmented system for drug price negotiation. Unlike many other developed countries where a single government agency or national health system negotiates prices on behalf of the entire population, the U.S. system involves pharmaceutical companies negotiating with numerous individual private insurers and Pharmacy Benefit Managers (PBMs).3 This structure limits the bargaining power of any single payer and allows manufacturers to employ “divide and conquer” strategies, maintaining higher prices overall.3

Table 1: U.S. vs. International Drug Price Ratios (2022 Data)

Sources: 4

This table quantifies the core issue of U.S. price disparity and provides concrete data points that underpin policy debates such as the Most Favored Nation proposal. It also highlights the crucial nuance that U.S. generic drug prices are comparatively lower, a factor often overlooked in broader discussions.

2. The “Most Favored Nation” (MFN) Policy: A Case Study in Price Control Attempts

In response to high U.S. drug prices, the Trump administration proposed a “Most Favored Nation” (MFN) executive order. This policy aimed to tie prices the U.S. government (primarily Medicare) pays for certain prescription drugs to the lowest price paid among a selection of comparable developed countries.3 Proposed mechanisms included facilitating direct-to-consumer (DTC) purchasing programs at the MFN price, establishing MFN price targets for manufacturers, and potentially allowing broader personal importation of drugs if substantial progress was not made voluntarily.9

The MFN proposal drew significant criticism from policy experts and industry stakeholders. Concerns were raised about its workability, with many arguing it ignored the fundamental economics of the global drug marketplace and questioned why pharmaceutical companies would voluntarily comply.11 Critics also warned of potential negative impacts on pharmaceutical innovation and the financial viability of biotech companies, particularly smaller firms.11 Some analyses suggested that MFN could lead to higher prices or reduced access to medicines in the reference countries, as manufacturers might refuse to sell at lower prices if those prices were then applied to the much larger U.S. market, ultimately harming global R&D.12

Implementation and legal challenges were also significant. Questions abounded regarding the President’s authority to implement such a policy administratively, the criteria for selecting “comparably developed nations,” the methodology for calculating price targets, and how such a system would integrate with existing programs like Medicare and Medicaid.9 Previous attempts by the Trump administration to implement similar MFN models were blocked by federal courts on procedural grounds.12 The specific impact on Medicaid remained an open question, though past legislative discussions had considered tying Medicaid drug prices to an MFN model.13

The MFN policy, designed to benefit the U.S., could have inadvertently created a “race to the bottom” in reverse. If pharmaceutical companies, to protect revenues in the lucrative U.S. market, chose not to launch new medicines in smaller, lower-priced “reference” countries or significantly raised prices there, patients in those nations could face higher costs or delayed access. This scenario could potentially reduce the overall global market size and profitability for new drugs, thereby disincentivizing R&D, particularly for conditions more prevalent in those markets or for drugs offering marginal benefits that are only viable under differential pricing schemes.

3. The Cost of Discovery: Deconstructing Pharmaceutical R&D Expenditures

Estimates for the cost of bringing a new drug to market vary widely and are a subject of intense debate. A widely cited 2014 study by the Tufts Center for the Study of Drug Development (CSDD) estimated the capitalized cost per approved new drug at $2.6 billion (in 2013 dollars), including out-of-pocket expenses of $1.395 billion, time costs (foregone returns on investment) of $1.163 billion, and $312 million for post-approval R&D.15 This represented a 145% increase from Tufts CSDD’s 2003 estimate.

More recently, a 2025 RAND Corporation study published in JAMA Network Open, analyzing data for 38 drugs approved by the FDA in 2019, presented a more nuanced picture. This study found a median capitalized R&D cost of $708 million and a mean of $1.3 billion, indicating that the average is heavily skewed by a few extremely high-cost outlier drugs.17 The median direct (out-of-pocket) cost was $150 million, with a mean of $369 million.17 This suggests that the “typical” cost of developing a new drug may be lower than the highest figures often quoted in policy discussions.

Key components driving these costs include direct out-of-pocket expenditures for preclinical research and clinical trials, the high failure rates across development phases (Phase II is often the largest hurdle, with only about 28.9% of candidates successfully transitioning to Phase III 19), long development times, and the cost of capital (the return investors expect for bearing the risk over many years).20 R&D costs also vary significantly by therapeutic area (with neurology, respiratory, and oncology being among the most expensive due to lower success rates and longer development times), the size of the pharmaceutical company, and whether the drug is a traditional chemical compound or a more complex biologic.20

Table 2: Estimates of Capitalized Pharmaceutical R&D Costs per New Approved Drug

Sources: 15

This table highlights the evolution and variation in R&D cost estimates. The discrepancy between mean and median figures, particularly in the more recent RAND/JAMA study, is crucial as it illustrates how a few very expensive drug development programs can skew the average, potentially overstating the “typical” cost. This challenges the narrative that uniformly high U.S. prices are justified solely by universally high R&D expenditures for every drug.

4. Innovation’s Price Tag: The Impact of Pricing Policies on Future Drug Development

A central contention in healthcare policy is the relationship between drug prices and pharmaceutical innovation. The pharmaceutical industry and some economists argue that high U.S. prices, which contribute significantly to global revenues, are essential to fund the costly and risky R&D process that leads to new medicines. Consequently, policies aimed at reducing U.S. drug prices, such as government negotiation or price controls like MFN, are predicted to diminish R&D investment and slow the pace of new drug approvals.

Several economic analyses support this view. An NBER working paper by Abbott and Vernon suggested that cutting U.S. prices by 40-50% could lead to 30-60% fewer early-stage R&D projects.21 A BFI Working Paper by Mulligan et al. estimated that price controls similar to those in H.R.3 (the Lower Drug Costs Now Act) could reduce R&D spending by 29-60% between 2021 and 2039, resulting in 167 to 342 fewer new drug approvals over that period.22 Research from the USC Schaeffer Center indicated that a 10% reduction in expected U.S. revenues could lead to a 2.5% to 15% decline in pharmaceutical innovation, such as clinical trial starts or new drug approvals.23

However, counterarguments exist. Critics contend that current U.S. drug prices far exceed what is necessary to fund R&D, with substantial profits often directed towards marketing, shareholder returns, and executive compensation rather than reinvestment in truly innovative research.24 Furthermore, public funding plays a significant role in pharmaceutical R&D. Taxpayers contribute heavily through National Institutes of Health (NIH) grants for basic research, which often lays the groundwork for new drug discoveries.24 One estimate suggests that 61% of vaccine development costs were publicly funded.25 This leads to the “pay twice” argument: taxpayers fund the initial research and then pay high prices for the resulting products.26 The Congressional Budget Office (CBO), for instance, projected a more modest impact of H.R.3 on the number of new drugs coming to market compared to some academic estimates.24 Some analyses also argue that a significant portion of “new” drugs offer little therapeutic advancement over existing treatments.24

The debate over the U.S. “subsidizing” global R&D is intensely political. While U.S. market revenues are undeniably crucial for pharmaceutical profits, the substantial public investment in basic research (e.g., via NIH) complicates the narrative of purely private-sector-funded innovation. This makes international burden-sharing discussions complex, as they involve not just private revenues but also public research contributions globally. Policy solutions like MFN, which focus only on price, may not address the more fundamental issue of optimizing global R&D funding mechanisms that acknowledge both public and private contributions across nations.

Table 3: Projected Impact of U.S. Price Controls on Pharmaceutical Innovation

Sources: 21

This table directly addresses a key tension: the trade-off between drug affordability and innovation. It presents a range of potential impacts, reflecting the inherent uncertainty and differing assumptions in economic modeling, and allows for a comparison of various analytical perspectives.

5. The Global R&D Burden: Is the U.S. Footing the Bill?

A recurring argument in U.S. drug pricing debates is that the nation disproportionately bears the global burden of pharmaceutical R&D costs. The premise is that higher prices in the U.S. market effectively subsidize the development of new drugs that benefit patients worldwide, while other developed countries “freeload” by implementing stringent price controls that limit pharmaceutical revenues in their markets.3 This “global freeloading” was a key justification for President Trump’s MFN proposal.9 A study in PNAS quantified this by suggesting that if a single international price for each drug were established across high-income OECD countries while keeping total pharmaceutical firm profits fixed, U.S. prices would fall by approximately half, while prices in every other country would increase, some by over 300%.28

Alternative perspectives challenge this narrative. They argue that other countries negotiate prices based on assessments of value, national health priorities, and their greater collective bargaining power, rather than simply “freeloading”.3 From this viewpoint, the MFN proposal misinterprets the fundamental reasons for high U.S. drug prices, which are rooted in its unique market structure rather than solely in the pricing decisions of other nations.12 Ethical considerations of distributive justice also arise, questioning how the benefits and burdens of pharmaceutical innovation and costs should be shared both within and among nations.29

Policy decisions on drug pricing are not merely economic calculations; they are deeply intertwined with political narratives about fairness, national contribution, and the intrinsic value of innovation. This makes evidence-based policymaking exceptionally challenging amidst powerful vested interests and entrenched ideological positions.

B. Industry Structures and Strategies

The pharmaceutical industry operates with unique business models and strategic imperatives shaped by patent law, regulatory landscapes, and the high-risk, high-reward nature of drug development.

1. From Blockbusters to Niche Cures: Evolving Pharmaceutical Business Models

The traditional “blockbuster drug model,” which focuses on developing and marketing drugs achieving over $1 billion in peak annual sales, has long been a cornerstone of the pharmaceutical industry. However, this model has faced increasing pressure due to factors such as declining R&D productivity (meaning more investment is needed per successful drug), escalating commercialization costs, growing influence from payers demanding value for money, and shorter effective patent lives.30 As early as 2003, a Bain & Company report declared the blockbuster model “broken,” projecting diminishing returns on investment.30

Despite these pressures, a 2024 McKinsey analysis indicates that the R&D performance of major pharmaceutical companies is still largely propelled by blockbuster and even “mega blockbuster” drugs.31 Companies are increasingly adopting “blockbuster seeking” portfolio strategies, directing a significant majority (80% or more) of their R&D investment towards a select few assets perceived to have the potential for at least $3 billion in peak-year sales.31 This suggests an entrenched path dependency or a lack of readily available alternative models capable of generating the massive revenues to which large pharmaceutical companies have become accustomed. This focus might occur at the expense of broader innovation in areas with smaller market potential but significant unmet medical needs. Concurrently, there is an observable shift towards developing more targeted therapies for smaller patient populations, including those for rare and orphan diseases, reflecting scientific advancements and, in some cases, more favorable regulatory pathways or pricing potential.32

2. The Patent Dance: Innovation, Exclusivity, and Generic Competition

Intellectual property rights, primarily patents and regulatory exclusivities, are fundamental to the pharmaceutical business model. Patents typically grant an inventor exclusive rights for 20 years from the filing date, though the effective market exclusivity period for a drug is often much shorter—typically 7 to 12 years after accounting for lengthy development and regulatory approval times.33 This exclusivity is intended to allow companies to recoup substantial R&D investments and incentivize further innovation.

The expiration of a drug’s patent often leads to a “patent cliff,” an abrupt and significant drop in revenue as generic competitors enter the market.33 Pfizer’s Lipitor is a classic example of a drug that experienced a dramatic sales decline post-patent expiry.33 The entry of generic drugs, which are bioequivalent to the brand-name product, leads to substantial price reductions—often 80-90% within the first year—and generates massive savings for healthcare systems and patients.33 A single generic competitor can reduce prices by 30%, while five or more can lead to price drops of nearly 85%.35 Data from IQVIA indicated that generic drugs saved the U.S. healthcare system $2.2 trillion between 2009 and 2019.35

While patents are designed to reward innovation, certain patenting practices have drawn criticism. Strategies sometimes referred to as “evergreening” or “product hopping” involve making minor modifications to existing drugs to obtain new patents and extend market exclusivity, often without offering significant additional therapeutic benefits.12 These practices can delay the entry of lower-cost generics and are seen by critics as prioritizing revenue preservation over the spirit of the patent system, which relies on eventual generic competition to ensure affordability.

3. Orphan Drugs: Incentivizing Development for Rare Diseases

Recognizing that market forces alone might not incentivize the development of treatments for rare diseases (affecting fewer than 200,000 people in the U.S.), the Orphan Drug Act (ODA) was enacted in 1983.37 The ODA provides a suite of incentives, including seven years of market exclusivity for an approved orphan indication, tax credits for qualified clinical trial expenses (originally 50%, later reduced to 25% 39), FDA fee waivers, and research grants.37

The ODA has been lauded for its success in stimulating the development of drugs for previously neglected conditions. Prior to 1983, only 38 drugs for rare diseases had FDA approval; by the end of 2022, this number had risen to 882 drugs for 392 rare diseases.38 Orphan drugs now constitute a significant proportion of novel FDA approvals; for example, in 2024, 26 out of 50 (52%) novel drugs approved by the FDA’s Center for Drug Evaluation and Research (CDER) had an orphan drug designation.40

Despite these successes, challenges remain. The development costs for orphan drugs can be disproportionately high relative to their small patient populations, contributing to what is termed the “orphan drug paradox”—where the high societal value of these therapies may not align with their commercial viability without significant incentives.37 The high prices of many approved orphan drugs have also become a major point of contention, raising concerns about patient access and healthcare system sustainability.37 Critics also question whether the incentives are always appropriately targeted or are sometimes exploited by companies for drugs that might have been developed anyway or for indications that later expand to larger populations.38 Importantly, despite the ODA’s impact, an estimated 95% of the more than 7,000 known rare diseases still lack an FDA-approved treatment, indicating a vast unmet need and suggesting that while the ODA is a vital tool, it has not fully resolved the complex challenges of rare disease drug development and access.38

The pharmaceutical industry’s strategies reflect a complex interplay of genuine scientific innovation, sophisticated financial engineering, and adaptive responses to regulatory incentives and market pressures. Policies aimed at this sector must therefore be designed with a nuanced understanding of these multifaceted behaviors to achieve desired outcomes without triggering detrimental unintended consequences.

C. The Regulatory Gatekeeper: The FDA’s Role and Reform

The U.S. Food and Drug Administration (FDA) serves as the critical gatekeeper for pharmaceutical products, tasked with ensuring their safety and efficacy before they can be marketed to the public.35 Its processes and efficiency are central to the pace of innovation and access to new medicines.

1. Navigating the Approval Pathway: Trends and Statistics

The FDA’s Center for Drug Evaluation and Research (CDER) is responsible for reviewing new drug applications. In 2024, CDER approved 50 novel drugs (new molecular entities and new therapeutic biologics not previously marketed in the U.S.), a figure consistent with the average of recent years.40 The 2024 approvals included 16 biologics (of which 13 were monoclonal antibodies), 30 small molecules, and 4 TIDES (Therapeutic Oligonucleotide or Peptide Drug Substance).41 Notably, 26 of these novel drugs received orphan drug designation for rare diseases, and CDER also approved a record 18 biosimilar products.40

The journey of a drug through clinical development to FDA approval is fraught with risk. The overall Likelihood of Approval (LOA) for a drug entering Phase I clinical trials was 7.9% for the period 2011-2020, according to a BIO report.19 Phase II development represents the most significant hurdle, with a success rate of only 28.9% for advancing to Phase III.19 Certain therapeutic areas, such as hematology (23.9% LOA from Phase I) and drugs for rare diseases (17.0% LOA from Phase I), have demonstrated higher overall success rates.19

Table 4: FDA New Drug Approvals – 2024 Snapshot (CDER)

Sources: 40

This table provides a current overview of FDA’s output, reflecting ongoing innovation trends, particularly the growing prominence of biologics and orphan drugs. These figures offer a baseline for discussions about R&D productivity and the impact of regulatory policies.

2. Striving for Efficiency: FDA Initiatives and Their Impact (PDUFA, 21st Century Cures, RWE)

Several legislative and administrative initiatives aim to enhance the efficiency of the FDA’s drug review and approval process. The Prescription Drug User Fee Act (PDUFA), first enacted in 1992 and reauthorized every five years (most recently as PDUFA VII for fiscal years 2023-2027), allows the FDA to collect user fees from pharmaceutical companies.42 These funds are intended to supplement congressional appropriations and provide resources to expedite the drug review process, with the FDA committing to specific performance goals for review timelines.43 While PDUFA has generally been credited with reducing review times, the model of an agency being partially funded by the industry it regulates inherently creates a dynamic that can lead to perceptions, or actual risks, of an overemphasis on speed, a long-standing tension in regulatory policy.

The 21st Century Cures Act of 2016 included provisions to modernize clinical trial design and evidence development, directing the FDA to facilitate the use of Real-World Data (RWD) and Real-World Evidence (RWE) in regulatory decision-making.43 RWE, derived from data collected outside of traditional randomized controlled trials (e.g., electronic health records, insurance claims), holds the potential to lower drug development costs and accelerate approval timelines, particularly for new indications of existing drugs or for rare diseases where large trials are difficult.43 However, progress in the broad adoption and integration of RWE into regulatory submissions has been described by some observers as “glacial,” suggesting that significant institutional, methodological, or industry-related hurdles remain in translating this policy intent into widespread practice.43

The FDA is also pursuing initiatives such as promoting Advanced Manufacturing Technologies (AMT) to improve drug quality, address potential shortages, and speed time-to-market, as well as exploring the application of Artificial Intelligence and Machine Learning (AI/ML) in drug development and manufacturing.44 While these reforms aim to reduce development costs and timelines, their full impact is contingent on successful implementation, industry uptake, and overcoming existing challenges.43

The high number of annual drug approvals is often presented as a sign of a robust innovation ecosystem. However, a critical perspective suggests that many of these approvals may not represent major therapeutic breakthroughs, with some analyses indicating that only 10-15% of new drugs offer true therapeutic advancements over existing treatments.24 This disconnect implies that raw approval numbers alone are an insufficient metric for assessing the societal value generated by the pharmaceutical R&D enterprise and the effectiveness of the regulatory system in promoting impactful innovation. Regulatory reform is an ongoing, iterative process, and initiatives like RWE adoption or advanced manufacturing require sustained effort, collaboration, and potentially further legislative action to overcome inertia and fully realize their benefits for drug development and patient access.

D. Public Trust and Pharmaceutical Reputation

The pharmaceutical industry operates within a complex social context where public trust is a critical, yet increasingly fragile, asset. Recent data indicate a significant erosion of public confidence in the sector.

A September 2023 Gallup poll revealed that only 18% of Americans hold a positive view of the pharmaceutical industry, while 60% view it negatively—a record low in Gallup’s polling trend.46 This decline was particularly pronounced among Republicans, whose positive rating dropped from 26% to 13% in the preceding year, a shift linked by Gallup to criticism from some conservative figures regarding the industry generally and COVID-19 vaccines specifically.46 This politicization of trust suggests that perceptions of the industry are increasingly filtered through broader political identities, moving beyond purely economic or efficacy concerns.

The 2025 Edelman Trust Barometer health report echoed these findings, describing plummeting trust in both pharmaceutical and healthcare institutions, especially among younger people (ages 18-34).47 A majority of global survey respondents believed that industry leaders, government officials, and journalists intentionally mislead the public on health topics.47 Among the reasons cited for this distrust, particularly by younger demographics, were a perceived lack of empathy from healthcare providers and a growing reliance on social media and peer networks for health advice over medical professionals.47 This trend towards unverified information sources carries potentially serious implications for public health outcomes, as it can lead to poor health decisions and non-adherence to effective treatments.

Other factors likely contributing to this erosion of trust include persistently high drug prices, perceptions of excessive corporate profits, and the lingering impact of public health crises such as the opioid epidemic, where the conduct of some pharmaceutical companies severely damaged the industry’s reputation.48 The consequences of this declining trust are manifold, potentially leading to patients disregarding essential medical advice, increased skepticism towards new medicines, and a more challenging environment for public health initiatives.

Table 5: Public Trust in the Pharmaceutical Industry (Recent Poll Findings)

Sources: 46

This table quantifies a critical contextual factor: the pharmaceutical industry operates in an environment of significant public skepticism. The cited reasons point to areas the industry and healthcare system must address. Rebuilding public trust will require more than just the development of effective drugs; it demands greater transparency, demonstrable ethical behavior, concrete actions to address affordability concerns, and credible communication strategies capable of navigating a polarized and often misinformed media landscape. The industry’s “social license to operate” appears to be under considerable strain.

IV. “The Power and the Money” in Practice: Government, Industry, and the Pharmaceutical Sector

Tevi Troy’s “The Power and the Money” provides a potent analytical lens through which to examine the intricate and often fraught relationship between the U.S. government, particularly the presidency, and the pharmaceutical industry. The book’s core themes—the pervasive reach of federal power, the imperative for corporate leaders to engage with Washington, the mutual dependencies and potential antagonisms between presidents and CEOs, and the delicate dance of influence and negotiation—are vividly illustrated in the healthcare arena.1

A. Applying Troy’s Framework: Presidential Influence and Corporate Strategy in Healthcare

In the context of the pharmaceutical sector, Troy’s framework highlights how the federal government, through agencies like the FDA, CMS (Centers for Medicare & Medicaid Services), and NIH, wields immense influence over drug approval, reimbursement, research funding, and market access. This makes engagement with Washington not just advisable but essential for pharmaceutical companies. CEOs in this sector often find themselves acting as “warriors on the frontlines,” as Troy describes 1, navigating complex policy battles over issues like drug pricing, intellectual property rights, regulatory standards, and responses to public health crises. The relationship is one of interdependence: the government relies on the industry for innovation and life-saving medicines, while the industry depends on government for market access, regulatory pathways, and often, foundational research support. This dynamic necessitates careful navigation by both sides to avoid what Troy terms “unpredictable costs and collateral damage”.1

B. The Trump Administration and Pharma: An Illustration of Intertwined Interests and Conflicts

The Trump administration’s interactions with the pharmaceutical industry offer a compelling case study of Troy’s themes in action. President Trump’s rhetoric often embodied the dual role presidents can play, at times defending pharmaceutical companies and their innovative contributions, while at other times castigating them for “profiteering and price gouging” and threatening investigations.3 This approach aligns with Troy’s observation that presidents may use CEOs and their industries as both “allies and convenient enemies” 1, particularly when employing populist appeals.

Key policy initiatives, most notably the “Most Favored Nation” (MFN) drug pricing proposal, represented a direct assertion of executive power aimed at compelling the industry to lower prices for Medicare Part B drugs by tying them to lower international benchmarks.3 This move exemplified the “vast reach of the federal government” becoming a “critical fact of life for every business,” as Troy articulates.1 The administration’s focus on the role of Pharmacy Benefit Managers (PBMs) as middlemen contributing to high drug costs also reflected a presidential attempt to reshape market dynamics and assign blame, potentially deflecting criticism from manufacturers or insurers and fitting Troy’s notion of presidents needing “foils”.1

The pharmaceutical industry’s response to these pressures illustrates the “intricate dance” Troy describes.1 It involved extensive lobbying efforts—PhRMA, the industry’s main trade group, spent a record $29 million on lobbying in 2019, partly in opposition to measures like H.R. 3 which aimed to lower drug costs 24—as well as legal challenges to initiatives like the MFN rule, which was ultimately blocked by courts.11 This pushback demonstrates the limits of presidential power when confronted by well-resourced, strategically adept corporate interests, a central “clash” dynamic explored in “The Power and the Money”.1

The unpredictable policy environment created by such a presidential approach—simultaneously courting and castigating a powerful industry—can impact long-term investment decisions, as companies are forced to react to shifting political winds rather than stable regulatory frameworks.

C. The Enduring Dance: How Pharmaceutical Leaders Navigate Washington

The pharmaceutical industry’s engagement with the federal government is a continuous and multifaceted endeavor. Companies employ a range of strategies, including sophisticated lobbying operations, campaign contributions to influential politicians, extensive public relations campaigns to shape public and policymaker perceptions, direct engagement with executive branch officials and congressional leaders, and the funding of research and think tanks to support policy positions favorable to the industry. The necessity of maintaining robust “public affairs teams and government relations experts,” as noted in summaries of Troy’s book 1, is paramount for survival and success in a sector so heavily regulated and politicized. These efforts are not merely defensive; they are proactive attempts to shape legislation, regulation, and reimbursement policies to align with corporate objectives. The relationship is a high-stakes, dynamic interplay that directly impacts national health policy, economic interests, and ultimately, public well-being. Understanding this through the historical and power-dynamic lens provided by Troy offers deeper insights than a purely policy-focused analysis.

V. Charting the Future: Research Directions and Policy Considerations

The complexities inherent in the U.S. pharmaceutical landscape—balancing innovation, affordability, access, and public trust—present numerous unanswered questions and necessitate ongoing policy refinement.

A. Unanswered Questions and Avenues for Future Research

Several areas warrant further investigation to inform evidence-based policymaking:

1. The True Elasticity of Innovation: While it is generally accepted that revenues influence R&D, the precise impact of different types and magnitudes of price changes or revenue reductions on specific kinds of pharmaceutical R&D remains unclear. Current estimates of this elasticity vary widely.21 Future research should aim to differentiate the impact on truly novel, breakthrough therapies versus incremental “me-too” drugs, and on treatments for large common diseases versus those for smaller, rare disease populations. Understanding these nuances is critical for designing price regulations that minimize harm to genuinely valuable innovation.
2. Optimal Models for Global R&D Cost Sharing: The narrative of the U.S. “freeloading” problem, where other developed nations benefit from U.S.-funded R&D without contributing proportionally to its costs 27, requires more sophisticated solutions than unilateral price controls. Research is needed to develop feasible and equitable international mechanisms for R&D funding and reward that balance national healthcare budgets, global public health needs, and sustainable innovation incentives.
3. Long-term Impact of Real-World Evidence (RWE) Adoption: The push to incorporate RWE into drug approval processes, as encouraged by the 21st Century Cures Act and PDUFA commitments 43, is still in its early stages. Longitudinal studies are essential to assess the actual impact of RWE on drug development timelines, overall costs, the rigor of approval standards, and, crucially, on patient safety and outcomes.
4. Effectiveness of Different Pharmacy Benefit Manager (PBM) Regulation Models: Given the increasing scrutiny of PBMs and their role in the drug supply chain 11, comparative research on the outcomes of various state-level or international regulatory approaches to PBM transparency, rebate pass-through, and formulary management could provide valuable insights for potential federal reforms.
5. Impact of Vertical and Horizontal Integration in Healthcare: The ongoing consolidation within the healthcare sector, including mergers between insurers, PBMs, specialty pharmacies, and provider groups, warrants investigation into its effects on drug pricing, market competition, formulary design, and patient access to medications.
6. Behavioral Economics of Patient Trust and Health Information Consumption: The documented decline in public trust in the pharmaceutical industry and healthcare institutions 46 calls for deeper research into its underlying drivers. Studies employing behavioral economics and communication theory could identify more effective strategies for rebuilding trust, combating misinformation, and improving health literacy in an increasingly polarized and complex information environment.

B. Policy Levers for Balancing Innovation, Affordability, and Access

Addressing the multifaceted challenges in the pharmaceutical sector requires a portfolio of policy interventions:

1. Value-Based Pricing and Negotiation: Moving towards systems where drug prices are more closely aligned with their demonstrated therapeutic value relative to existing treatments is a key strategy. This could involve strengthening and expanding Medicare’s drug price negotiation authority, building upon the framework established by the Inflation Reduction Act (IRA) 49, and developing more robust comparative effectiveness research infrastructure.
2. Reforming Patent and Exclusivity Rules: To ensure a fair balance between rewarding innovation and facilitating timely access to affordable generic and biosimilar medicines, reforms could target practices such as “patent thickets,” “product hopping,” or “evergreening” that may unduly delay competition without offering significant new clinical benefits.34
3. Targeted R&D Incentives for Unmet Needs: While broad price controls might stifle some innovation, more targeted incentives—such as enhanced tax credits, grants, priority review vouchers, or novel market entry rewards—could be refined or expanded for areas of high unmet medical need where market forces alone are insufficient. Examples include the development of new antibiotics to combat antimicrobial resistance, treatments for neglected tropical diseases, or therapies for rare conditions not adequately covered by existing Orphan Drug Act provisions.37 These incentives should be coupled with considerations for affordability and access.
4. Enhancing FDA Capacity and Regulatory Modernization: Continued investment in the FDA’s resources, scientific expertise, and data infrastructure is crucial for the agency to efficiently review increasingly complex therapies (e.g., cell and gene therapies), effectively incorporate novel data sources like RWE, and oversee advanced manufacturing technologies.42
5. Promoting Transparency Across the Supply Chain: Greater transparency in net drug prices (after rebates and discounts), the financial arrangements between manufacturers and PBMs, and the allocation of R&D expenditures by pharmaceutical companies could improve market accountability and inform policy debates.
6. Constructive International Collaboration: Rather than pursuing unilateral measures like MFN pricing, which may have unintended negative consequences 12, the U.S. could engage in proactive international dialogues on pharmaceutical policy, coordinated approaches to R&D funding for global health priorities, and strategies for ensuring equitable access to innovative medicines worldwide.

The impact of any policy intervention in the pharmaceutical sector is not a static, one-time event but rather an evolving process. Future research must focus on these dynamic effects, including feedback loops and unintended consequences, as the industry and other stakeholders strategically adapt over time. Issues such as high prices, gaps in innovation, and low public trust are deeply interconnected. Consequently, policy solutions that target one area in isolation—for instance, focusing solely on price controls without considering innovation incentives, or vice versa—are likely to have limited success or may even create new problems. A more holistic approach, as suggested by some analyses 50, that simultaneously addresses pricing based on value, provides targeted incentives for true innovation, ensures robust regulatory oversight, and fosters transparency, is more likely to achieve a sustainable and socially beneficial equilibrium. Crafting effective and enduring pharmaceutical policy requires a long-term vision, a commitment to continuous research and evaluation, and a willingness to adapt strategies as new evidence emerges and market dynamics shift.

VI. Conclusion: Synthesizing Perspectives on a Critical Nexus

The intersection of healthcare policy, pharmaceutical industry dynamics, and governmental power represents one of the most complex and consequential arenas in modern society. The dialogue between commentators and experts, such as the hypothetical one between Ben Shapiro and Tevi Troy, serves to highlight the multifaceted nature of these challenges and the often-competing values at stake.

A. Recap of Key Insights from the Analysis

This report has traversed the landscape of U.S. drug pricing, revealing significant premiums compared to international counterparts, driven by a fragmented negotiation system.3 Attempts to address this, such as the Most Favored Nation policy, have faced substantial criticism regarding feasibility and potential negative impacts on global R&D and access.11 The actual cost of pharmaceutical R&D is a nuanced figure, with recent data suggesting that while substantial, the “typical” cost may be lower than outlier-skewed averages often cited.17 The impact of price controls on innovation remains a contentious debate, with studies projecting outcomes ranging from modest to severe reductions in new drug development.22

The pharmaceutical industry employs sophisticated strategies, from the pursuit of blockbuster drugs to navigating patent laws and leveraging incentives like the Orphan Drug Act, all while facing declining public trust.30 The FDA, as the regulatory gatekeeper, strives for efficiency through initiatives like PDUFA and the incorporation of RWE, though challenges in implementation persist.42 Tevi Troy’s framework in “The Power and the Money” 1 proves invaluable in understanding these dynamics, particularly when examining the Trump administration’s interactions with the pharmaceutical sector, which illustrated the potent mix of presidential influence, corporate strategy, and public pressure.

B. The Enduring Tension Between Market Forces, Public Health Needs, and Political Power

At its core, the pharmaceutical sector embodies an enduring tension. It relies heavily on market-based incentives, intellectual property rights, and profit motives to fuel the innovation that produces life-saving and life-enhancing public health goods. However, the very mechanisms designed to spur innovation can also lead to outcomes—such as high prices and access barriers—that conflict with public health objectives and societal notions of fairness and equity.

Political power, as explored in Troy’s work, is a constant and critical variable in this equation. Government actions, whether through regulation, legislation, negotiation, or executive orders, profoundly shape the operating environment for the pharmaceutical industry. Conversely, the industry wields considerable influence through lobbying, campaign finance, and shaping public narratives. The resulting policies are often a product of these power dynamics, reflecting compromises, victories, and stalemates between various stakeholders, including patient advocacy groups, insurers, healthcare providers, and the public at large. The ongoing societal negotiation over values, resources, and priorities in healthcare is reflected in, and influenced by, public discourse featuring diverse perspectives like those of Shapiro and Troy.

The issues discussed are not merely technical or economic; they are fundamentally matters of political economy. Decisions about who pays for medicines, who profits from their sale, who benefits from innovation, and who bears the risks associated with new treatments are inherently political. They involve power struggles and the allocation of societal resources, making Tevi Troy’s analysis of the nexus between political and economic power particularly relevant.

There is likely no permanent “solution” to the inherent tensions within the pharmaceutical sector. Instead, what emerges is an ongoing search for a dynamic equilibrium that society, through its political processes, finds acceptable at any given time. This equilibrium is inherently unstable, subject to shifts driven by scientific advancements (e.g., the advent of high-cost gene therapies), changing economic conditions, evolving public expectations, and shifting political priorities (e.g., an outcry over a specific drug price, or intense demand for rapid innovation during a pandemic). Policymaking in this domain is therefore less about finding a final, definitive answer and more about continuously managing these competing demands and recalibrating the balance between incentivizing innovation and ensuring affordable access. An informed citizenry and engaged, evidence-receptive policymakers are crucial for navigating these complex trade-offs to ensure that the pharmaceutical system, and the broader healthcare apparatus, ultimately serves the public interest while fostering the innovation necessary for future health advancements.

VII. References

.1

Works cited

1. The Power and the Money: The Epic Clashes Between …, accessed May 14, 2025, https://www.amazon.com/Power-Money-Clashes-Commanders-Industry/dp/1684515408
2. The Power and the Money: The Epic Clashes Between Commanders in Chief and Titans of Industry by Tevi Troy, Hardcover | Barnes & Noble®, accessed May 14, 2025, https://www.barnesandnoble.com/w/the-power-and-the-money-tevi-troy/1145168201
3. FACT FOCUS: Trump blames other countries for high US drug prices. Experts say it’s not their fault - AP News, accessed May 14, 2025, https://apnews.com/article/fact-check-trump-drug-prices-subsidize-healthcare-a7a41cf2dbfb34fb39ecc38ea728c473
4. www.rand.org, accessed May 14, 2025, https://www.rand.org/content/dam/rand/pubs/research_reports/RRA700/RRA788-3/RAND_RRA788-3.pdf
5. Comparing Prescription Drugs in the U.S. and Other Countries: Prices and Availability, accessed May 14, 2025, https://aspe.hhs.gov/sites/default/files/documents/d5541b529a379d1f908ed2f9c00a9255/aspe-cover-idr-pricing-availability.pdf
6. Comparing Prescription Drugs in the U.S. and Other Countries …, accessed May 14, 2025, https://aspe.hhs.gov/reports/comparing-prescription-drugs
7. International Prescription Drug Price Comparisons: Estimates Using 2022 Data | RAND, accessed May 14, 2025, https://www.rand.org/pubs/research_reports/RRA788-3.html
8. Viewpoints: Most-Favored-Nation Pricing Would Balance Drug Costs; Oregon Model Could Reshape Medicaid - KFF Health News, accessed May 14, 2025, https://kffhealthnews.org/morning-breakout/viewpoints-most-favored-nation-pricing-would-balance-drug-costs-oregon-model-could-reshape-medicaid/
9. Trump Attempts To Reign In Drug Prices With Most-Favored-Nation …, accessed May 14, 2025, https://www.skadden.com/insights/publications/2025/05/trump-attempts-to-reign-in-drug-prices-with-most-favored-nation-approach
10. Trump Administration Revives Most-Favored-Nation Drug Pricing: Here’s What to Know, accessed May 14, 2025, https://www.hklaw.com/en/insights/publications/2025/05/trump-administration-revives-most-favored-nation-drug-pricing
11. Trump’s Favored Nation Drug Pricing is Unworkable, Critics Say, accessed May 14, 2025, https://www.managedhealthcareexecutive.com/view/trump-s-favored-nation-drug-pricing-is-unworkable-critics-say
12. The Market for Prescription Drugs Is Broken. Here’s Why Trump’s …, accessed May 14, 2025, https://www.cgdev.org/blog/market-prescription-drugs-broken-heres-why-trumps-executive-order-would-make-it-worse
13. Will President Trump’s Executive Order Lower Drug Prices? - KFF, accessed May 14, 2025, https://www.kff.org/quick-take/will-president-trumps-executive-order-lower-drug-prices/
14. President Trump signs Executive Order aimed at reducing prescription drug prices, accessed May 14, 2025, https://www.dlapiper.com/en-es/insights/publications/2025/05/president-trump-signs-executive-order-aimed-at-reducing-prescription-drug-prices
15. Tufts Center for the Study of Drug Development - Cost of Developing …, accessed May 14, 2025, https://www.appliedclinicaltrialsonline.com/view/tufts-center-study-drug-development-cost-developing-new-drugs
16. New study claims that cost to develop new drug is $2.6 billion - Bioanalysis Zone, accessed May 14, 2025, https://www.bioanalysis-zone.com/new-study-claims-that-cost-to-develop-new-drug-is-2-6-billion/
17. Typical Cost of Developing a New Drug Is Skewed by Few High-Cost Outliers | RAND, accessed May 14, 2025, https://www.rand.org/news/press/2025/01/07.html
18. Use of Clinical Trial Characteristics to Estimate Costs of New Drug Development - PMC, accessed May 14, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC11704977/
19. go.bio.org, accessed May 14, 2025, https://go.bio.org/rs/490-EHZ-999/images/ClinicalDevelopmentSuccessRates2011_2020.pdf
20. The R&D Cost of a New Medicine - OHE, accessed May 14, 2025, https://www.ohe.org/wp-content/uploads/2014/07/380-RD-Cost-NME-Mestre-Ferrandiz-2012.pdf
21. The Effect of Price Controls on Pharmaceutical Research | NBER, accessed May 14, 2025, https://www.nber.org/digest/may05/effect-price-controls-pharmaceutical-research
22. The Evidence Base on the Impact of Price Controls on Medical Innovation, accessed May 14, 2025, https://bfi.uchicago.edu/wp-content/uploads/2021/09/BFI_WP_2021-108.pdf
23. Analysis Finds Meaningful Impact on Pharmaceutical Innovation From Reduced Revenues, accessed May 14, 2025, https://schaeffer.usc.edu/research/pharmaceutical-innovation-revenues-drug-prices/
24. Taking Action To Reduce Drug Prices Will Not Harm Innovation, accessed May 14, 2025, https://www.protectourcare.org/wp-content/uploads/2021/06/POC-Fact-Sheet-Taking-Action-To-Reduce-Drug-Prices-Will-Not-Harm-Innovation-.pdf
25. Full article: A novel perspective on pharmaceutical R&D costs: opportunities for reductions, accessed May 14, 2025, https://www.tandfonline.com/doi/full/10.1080/14737167.2022.1987219
26. Federal Support Should Not Be A Factor In Determining Pharmaceutical Prices Under The IRA | Health Affairs Forefront, accessed May 14, 2025, https://www.healthaffairs.org/do/10.1377/forefront.20240613.956455/
27. Put Americans First by Ending Global Freeloading | Issues - America First Policy Institute, accessed May 14, 2025, https://americafirstpolicy.com/issues/put-americans-first-by-ending-global-freeloading
28. Policy options for the drug pricing conundrum - PNAS, accessed May 14, 2025, https://www.pnas.org/doi/10.1073/pnas.2418540122
29. Ethical Perspectives on Costly Drugs and Health Care - Neurology.org, accessed May 14, 2025, https://www.neurology.org/doi/10.1212/WNL.0000000000012571
30. www.bain.com, accessed May 14, 2025, https://www.bain.com/contentassets/040b2c20d74b4a42b262d0b0a3067a9b/rebuilding_big_pharma.pdf
31. Making more medicines that matter - McKinsey & Company, accessed May 14, 2025, https://www.mckinsey.com/industries/life-sciences/our-insights/making-more-medicines-that-matter
32. The Real Cost of Delays in Drug Development and the Role of RBQM and QbD, accessed May 14, 2025, https://cyntegrity.com/the-real-cost-of-delays-in-drug-development-and-the-role-of-rbqm-and-qbd/
33. The Impact of Patent Expiry on Drug Prices - DrugPatentWatch …, accessed May 14, 2025, https://www.drugpatentwatch.com/blog/the-impact-of-patent-expiry-on-drug-prices-a-systematic-literature-review/
34. The Role of Patents and Regulatory Exclusivities in Drug Pricing | Congress.gov, accessed May 14, 2025, https://www.congress.gov/crs-product/R46679
35. The Generic Drug Approval Process | FDA, accessed May 14, 2025, https://www.fda.gov/drugs/cder-conversations/generic-drug-approval-process
36. The More Things Change: Improvement Patents, Drug Modifications, and the FDA - Senate Judiciary Committee, accessed May 14, 2025, https://www.judiciary.senate.gov/download/karshtedt-dimitry-the-more-things-change-iowa-law-review?download=1
37. Navigating the Orphan Drug Ecosystem - DrugBank Blog, accessed May 14, 2025, https://blog.drugbank.com/navigating-the-orphan-drug-ecosystem/
38. The Orphan Drug Act at 40: Legislative Triumph and the Challenges of Success, accessed May 14, 2025, https://www.milbank.org/quarterly/articles/the-orphan-drug-act-at-40-legislative-triumph-and-the-challenges-of-success/
39. The Orphan Drug Act at 40: Legislative Triumph and the Challenges of Success - PMC, accessed May 14, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC10938927/
40. www.fda.gov, accessed May 14, 2025, https://www.fda.gov/media/184967/download?attachment
41. The Pharmaceutical Industry in 2024: An Analysis of the FDA Drug …, accessed May 14, 2025, https://www.mdpi.com/1420-3049/30/3/482
42. Prescription Drug User Fee Act - FDA, accessed May 14, 2025, https://www.fda.gov/media/177976/download?attachment
43. Expanding the Use of Real-World Evidence Can Make FDA Regulatory Decisions Faster, Cheaper, and Just as Safe | Manhattan Institute, accessed May 14, 2025, https://manhattan.institute/article/expanding-the-use-of-real-world-evidence-can-make-fda-regulatory-decisions-faster-cheaper-and-just-as-safe
44. Advanced Manufacturing - FDA, accessed May 14, 2025, https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/advanced-manufacturing
45. What FDA Is Doing to Lower Rx Prices, Congress Can Help - Commonwealth Fund, accessed May 14, 2025, https://www.commonwealthfund.org/publications/issue-briefs/2018/apr/what-commissioner-gottliebs-fda-doing-lower-prescription-drug
46. Retail, Pharmaceutical Industries Slip in Public Esteem - Gallup News, accessed May 14, 2025, https://news.gallup.com/poll/510641/retail-pharmaceutical-industries-slip-public-esteem.aspx
47. Trust in pharma and health care industries plummet with young …, accessed May 14, 2025, https://marketingandpharma.com/trust-in-pharma-and-health-care-industries-plummet-with-young-people-leading-the-way-report/
48. West Virginia court declines to answer whether opioids distribution can cause public nuisance - AP News, accessed May 14, 2025, https://apnews.com/31f030451eed47c34718c24d948dd4c9
49. A Report in Response to the Executive Order on Lowering Prescription Drug Costs for Americans - CMS, accessed May 14, 2025, https://www.cms.gov/priorities/innovation/data-and-reports/2023/eo-rx-drug-cost-response-report
50. Addressing the Trade-Off Between Lower Drug Prices and Incentives for Pharmaceutical Innovation - Brookings Institution, accessed May 14, 2025, https://www.brookings.edu/articles/addressing-the-trade-off-between-lower-drug-prices-and-incentives-for-pharmaceutical-innovation/
51. No Good Drug Goes Unpunished: Enforcing Innovation Through Tort Law and Infringing on Free Enterprise, accessed May 14, 2025, https://scholarlycommons.law.cwsl.edu/cgi/viewcontent.cgi?article=1785&context=cwlr
52. Are Cell and Gene Therapy programs a better bet? - Newdigs, accessed May 14, 2025, https://newdigs.tuftsmedicalcenter.org/wp-content/uploads/2023/10/NEWDIGS-Success-Rate-Comparison-2023F210v056.pdf
53. Regulatory Impact Analyses (RIA) - FDA, accessed May 14, 2025, https://www.fda.gov/economics-staff/regulatory-impact-analyses-ria
54. Tort Reform and Innovation - The University of Chicago Press: Journals, accessed May 14, 2025, https://www.journals.uchicago.edu/doi/pdfplus/10.1086/694337
55. How Proposed Drug Pricing and Patent Reform Bills Will Impact US Pharma Innovation, accessed May 14, 2025, https://www.nge.com/news-insights/in-the-media/how-proposed-drug-pricing-and-patent-reform-bills-will-impact-us-pharma-innovation/
56. Healthcare Insights - The Harris Poll, accessed May 14, 2025, https://theharrispoll.com/industries/healthcare/
57. Tariffs on medicines would harm American competitiveness, industry and patients - PhRMA, accessed May 14, 2025, https://phrma.org/blog/tariffs-on-medicines-would-harm-american-competitiveness-industry-and-patients
58. Use of Clinical Trial Characteristics to Estimate Costs of New Drug Development, accessed May 14, 2025, https://www.researchgate.net/publication/387761140_Use_of_Clinical_Trial_Characteristics_to_Estimate_Costs_of_New_Drug_Development
59. Innovative Drugs, Products Liability, Regulatory Compliance, and Patient Choice - eRepository @ Seton Hall, accessed May 14, 2025, https://scholarship.shu.edu/cgi/viewcontent.cgi?article=3128&context=shlr
60. Flaws in the Preemption Defense to Liability Claims Against Generic Drug Manufacturers - University of Miami School of Law Institutional Repository, accessed May 14, 2025, https://repository.law.miami.edu/umlr/vol79/iss3/3/
61. State Court Rejection of Federal Preemption in Product Liability Claim Highlights Uncertainty for Manufacturers - McGuireWoods, accessed May 14, 2025, https://www.mcguirewoods.com/client-resources/alerts/2025/3/state-court-rejection-of-federal-preemption-in-product-liability-claim-highlights-uncertainty-for-manufacturers/
62. The Pharmaceutical Industry Under Torts - American University, accessed May 14, 2025, https://aura.american.edu/articles/journal_contribution/The_Pharmaceutical_Industry_Under_Torts/23773575
63. Neither Goose Nor Gander: Why Tort Reform Fails All - The Florida Bar, accessed May 14, 2025, https://www.floridabar.org/the-florida-bar-journal/neither-goose-nor-gander-why-tort-reform-fails-all/
64. How Legal Battles in the Pharmaceutical Industry Impact Entrepreneurs - Business Age, accessed May 14, 2025, https://www.businessage.com/post/how-legal-battles-in-the-pharmaceutical-industry-impact-entrepreneurs
65. The Effects of False Claims Act Whistleblowers on the Pharmaceutical Industry - Harvard DASH, accessed May 14, 2025, https://dash.harvard.edu/server/api/core/bitstreams/7312037c-9cd4-6bd4-e053-0100007fdf3b/content
66. Healthcare And Tort Reform | Manhattan Institute, accessed May 14, 2025, https://manhattan.institute/article/healthcare-and-tort-reform
67. Trial Lawyers, Inc. - Manhattan Institute, accessed May 14, 2025, https://media4.manhattan-institute.org/pdf/TLI-ASBESTOS.pdf
68. American Tort Reform Association - ATRA, accessed May 14, 2025, https://www.atra.org/
69. Resources - ATRA - American Tort Reform Association, accessed May 14, 2025, https://www.atra.org/resources/
70. accessed December 31, 1969, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2828689
71. accessed December 31, 1969, https://www.judiciary.senate.gov/imo/media/doc/2005-02-08TroyTestimony.pdf
72. accessed December 31, 1969, https://www.healthaffairs.org/doi/10.1377/forefront.20240613.956455
73. accessed December 31, 1969, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11704977/