The Food and Drug Administration (FDA) has the awesome responsibility of regulating the powerful pharmaceutical industry. Most people believe that the FDA is a government agency that is fully funded by taxpayers and that it represents the gold standard in drug and medical device approval in the entire world. It’s true that the FDA is a government agency. While taxpayers still provide about one third of the FDA’s funding, the agency receives most its drug-review funding from the pharmaceutical industry through “user fees.” So, who does the FDA serve – U.S. citizens or the huge pharmaceutical companies?

Under the Prescription Drug Use Fee Act (PDUFA) of 1992, drug companies pay user fees to get drugs approved. Initially, Congress pass PDUFA to provide a budget to hire more scientists and researchers to deal with the new drug application workload because companies complained about how long it took to obtain approval of a new drug. Since 1992, reauthorizations of the act have weakened standards. For example, it allowed companies to use one trial instead of two to approve a drug in some cases.

While requiring pharmaceutical companies to help finance the agency that regulates them may not be a bad thing, it raises some serious concerns. Are pharmaceutical companies no longer private companies, but government-sponsored enterprises like Fannie Mae? Big Pharma pays the FDA that approves their drugs; they hire FDA employees and they lobby the politicians who oversee the FDA. The consumer ultimately must pay for all of that. Since that is the case, would we be better off funding the FDA with tax dollars only and making all FDA employees off limits to be employed by a pharmaceutical company or to lobby at FDA for a period of time after leaving the FDA?

I find that most folks believe the FDA tests every drug before the drugs are approved by the agency to be sold to consumers. Actually, the FDA does not test a single drug. Instead, the agency depends on the drug companies to test the drugs. We have seen lots of abuses in that system.

Is the FDA an independent agency looking out for the consumer? I have to believe there are FDA employees who hold themselves to a high standard. But we should all be concerned that the drug industry has come to rely on the FDA and politicians to feather its nest.

Sources: How Big Pharma controls the FDA. Crony Capitalism in American, Chapter 15 by Hunter Lewis and Misplaced Trust – Drugwatch by Michelle Llamas



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