A Forbes article from 2018 highlights a very serious problem with the drug and vaccine approval process.
Jun 28, 2018 Forbes
Caroline Chen of ProPublica has written a provocative article challenging the objectivity of the FDA in its approval of new drugs. Entitled: “FDA Repays Industry by Rushing Risky Drugs to Market”, Chen contends that the agency is beholden to the biopharmaceutical industry which pays three quarters of the FDA’s budget used for the drug review process.
This is an astounding number. Is any other federal agency supported to this extent by the industry it regulates? Given this level of support, one might assume that the FDA would bend over backwards to meet the needs of its financial backers.
How did we ever get to the point where private industry is providing so much support for a federal agency?
Actually, this all began about 25 years ago, when the U.S. was facing a “drug lag”. Because of a lack of resources at the FDA, drugs were being approved at a much slower rate here than in Europe. More than half of all drugs approved in the U.S. had been approved in Europe more than a year earlier. Patients, advocacy groups, pharmaceutical companies, and physicians were all concerned that important new medicines were being denied to Americans.
To solve this problem, Congress enacted the Prescription Drug User Fee Act (PDUFA) of 1992–a mechanism whereby charges were levied on pharmaceutical companies for each new drug application (NDA) filed. The revenues, known as “user fees”, were used to hire 600 new drug reviewers and support staff. These new medical officers, chemists, pharmacologists, and other experts were tasked with clearing the backlog of NDAs awaiting approval. In fact, one of the biggest years of NDA approvals occurred in 1996 when the FDA approved 56 new products, largely the result of working through this backlog.