Note the date. Perhaps, with Operation Warp Speed, the FDA is merely repaying industry for the millions industry paid them to “rush risky drugs to market.”
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”.
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 [were] known as “user fees”,
As a concession to agreeing to these “user fees”, the pharmaceutical industry was promised that the FDA would reduce review times of NDAs
“User fees” have gone up over the years, from $208,000 per NDA in 1995 to a whopping $2,421,495 for fiscal year 2018.
Chen’s concern about the rapid approval on drugs on the basis of limited data or based on surrogate endpoints merits discussion. In fact, it’s a worry that I have shared. It is important that a drug maker prove the benefits of its drug before unleashing it on the public.
When you ask anyone involved in drug R&D about pro-industry bias on the part of the FDA, they laugh.
In 2018, drug companies paid the government $2.4 million to expedite the review process for a drug, one drug. Honestly, it’s like sanctioned corruption.