What Needs to Change at the FDA? A PharmedOut Report


From PharmedOut: “Amendments to the Federal Food, Drug, and Cosmetic Act, passed in 1962, significantly strengthened the FDA’s powers and bolstered its reputation globally. Known as the Kefauver- Harris amendments, the legislation granted the agency power to restrict advertisements, establish standards for clinical trials, and require drug manufacturers to provide proof of efficacy. These amendments alarmed the industry, which joined with economists at the Chicago School of Economics who were opposed to economic policies designed to serve the public interest.

Together they built a network of economists and thought leaders who formed an echo chamber of policy ideas critical of the FDA. In this ongoing project to bend the FDA’s purpose to the industry’s ends, the 1992 Prescription Drug User Fee Act (PDUFA) was one tangible change with far-reaching consequences. By rendering the FDA significantly dependent on user fees paid by pharmaceutical sponsors, PDUFA launched three decades of regulatory permissiveness and inconsistency that have distorted the agency’s standards of evidence, resulting in decisions that too often favor the interests of industry over those of the public.

The FDA previously emphasized assessing the safety and efficacy of products before approval, but in recent years the agency has emphasized studying safety and effectiveness after a drug is on the market. Expedited approval pathways allow companies to market drugs that have only been tested on indirect surrogate outcome measures (for example, lab tests) rather than direct patient outcomes: how a patient feels, functions, or survives. Although the expectation is that confirmatory studies with patient-oriented outcomes will be conducted after approval, those studies are often not completed in a timely manner. When post-marketing studies show a drug or medical device is ineffective–or harmful–it often stays on the market for years. While it is obviously in industry’s interest to keep selling disproven products, the FDA should take a stronger stand in forcing unsafe or ineffective products off the market.

This paper examines four main themes regarding problems at the FDA: transparency and accountability, innovation, pre- and post-market standards of evidence, and value in healthcare.”

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