Reforming the FDA to Keep Lead in New Drugs, by Thomas A. Hemphill

Thomas A. Hemphill

The Reason Foundation, a libertarian think tank, recently released a policy brief (“Focus on the FDA: Allowing the Market to Determine Effectiveness”) that “reimagines” pharmaceutical regulation in the United States, with the aim of better serve society by encouraging the increased availability of life-saving medicines at lower prices.

The Food and Drug Administration is an agency of the Department of Health and Human Services responsible for ensuring the safety, efficacy, quality, and safety of human and veterinary drugs, vaccines, and other biological products, and medical devices, among other products.

Recently, however, critics have accused the agency – which regulates 20% of the US consumer economy – of unnecessarily delaying the rollout of COVID-19 testing and slowing the approval of lifesaving drugs for patients.

The FDA plays a strategic role not only for American consumers regarding their accessibility to pharmaceutical products, but also ensures the national security and global competitiveness of medical vaccines, treatments and medical devices. Of the 20 largest pharmaceutical companies in the world (based on drug sales revenue in 2021), 10 are American pharmaceutical companies, including five of the top 10 – Johnson & Johnson (first at 93.77 billion dollars), Pfizer (second at $81.29 billion), AbbVie (fourth at $56.2 billion), Merck (sixth at $48.7 billion) and Bristol Myers Squibb (seventh at $42.5 billion). dollars). These 10 US pharmaceutical companies generated an incredible $440.4 billion in revenue in 2021.

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To address FDA regulatory shortcomings and to accelerate and encourage pharmaceutical development of innovative products, the Reason Foundation offers four policy recommendations.

First, repeal the 1962 efficiency amendment. This repeal will have no adverse effect on pharmaceutical safety protocols. The potential efficacy of pharmaceuticals is best assessed by healthcare professionals (at the patient level) and professional associations (as a whole).

Today, physicians already perform this function by prescribing drugs for off-label use. The initial charge of “safety” for the FDA must remain with the agency, as the FDA is considered an international “gold standard” for safe drugs.

Rather than repealing the Efficacy Amendment of 1962, the legislation should be amended to require the drug candidate to pass the requirement for phase II clinical trials involving 100 to 300 patient volunteers. This phase provides a favorable indication of efficacy without the costly and time-consuming Phase III studies required to fully assess pharmaceutical efficacy, reducing the time up to half (six years) compared to the existing average approval process of the agency (12 years) .

Second, encourage financially responsible private actors to directly exercise increased surveillance powers. Since the FDA bears no legal responsibility for its decisions, that authority should be passed on to parties that bear financial responsibility, such as health insurers and managed care agencies, who recommend treatments and are arguably better placed to assess the efficacy of a pharmaceutical product. . It is advisable to transfer the financial responsibility to “private actors” with a strong pecuniary interest in reducing their expenditure, maximizing the efficiency of care and passing on part of the savings to the consumer.

Third, make the FDA a certifier of certifiers. Privatize a substantial amount of work currently done by the FDA while allowing the agency to retain formal oversight of these functions. The FDA could promulgate standards for private reviewers of clinical trial data and randomly audit the records of such reviewers. This recommendation is a cost-effective (and likely more timely) method of managing and using this important data for treatment efficacy (and potential long-term safety issues that emerge).

Fourth, the FDA could reciprocally recognize approvals issued by regulatory authorities in other advanced countries, such as the United Kingdom or European Union countries. This will allow US pharmaceutical manufacturers to conduct clinical trials in other countries.

The United States is the world leader in pharmaceutical research and development, thanks in large part to strong intellectual property protections and legislation that incentivizes risk-taking, as evidenced by most investment indices. in R&D and innovation. From 2004 to 2018, US-based companies produced nearly twice as many new drugs as their European counterparts, and three to four times as many as Japan. Yet to maintain this global economic leadership and ensure that the United States continues to respond to new public health challenges, an FDA actively adopting a 21st century drug regulatory regime is imperative to maintaining future safety and economic competitiveness. of the nation.

Thomas A. Hemphill is a professor of strategy, innovation, and public policy at the University of Michigan-Flint School of Management.

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