Who Funds the FDA? Follow the Money.

The Food & Drug Administration (FDA) is supposed to represent and protect the American public. But does FDA’s massive funding from large pharmaceutical manufacturing companies influence the agency to look after the interests of the large drug companies instead? Just follow the money for the answer.

As disclosed in its October 2019 report, in FY2019, FDA’s budget was $5.7 billion. Of this total, 33 percent, or approximately $1.9 billion, was spent on approving and regulating human drugs. Of this $1.9 billion, 65 percent was collected from drug-industry user fees. In other words, FDA’s biggest client when it comes to regulating drugs is Big Pharma, not the American public.

Compounded medications, which are not FDA-approved because they are regulated by state boards of pharmacy and compounded under stringent guidelines of the U.S. Pharmacopeia, generate $0 in FDA drug-approval fees. Overall, compounded medications are estimated to have a three- to five-percent market share of total human drugs. Some estimates show that Compounded Bioidentical Hormone Replacement Therapy (cBHRT) has a market share approaching 50 percent for hormones. So, this is an area in which the preferred choice of prescribers, men and women patients for cBHRT disproportionately affects Big Pharma’s profits.

FDA is planning to greatly restrict or even take compounded bioidentical hormones off the market. Why? Follow the money.