The FDA’s new clothes

The Vioxx disaster in the early 2000s triggered a crisis of mistrust in the US Food and Drug Administration (FDA), as evidence emerged that it had downplayed or ignored evidence of serious cardiovascular harm associated with Vioxx (rofecoxib), a cyclo-oxygenase-2 selective non-steroidal anti-inflammatory drug.

The result was a renewed emphasis on drug safety throughout a product’s lifecycle. At the same time, drug companies, which provide most of the funds for the FDA’s review of their drugs, kept pushing for faster approvals and new uses for old drugs, supposedly so that more patients could benefit. Any possible risks in getting new drugs to market more quickly would be offset by more intensive monitoring once they were being prescribed.

Two linked papers (doi:10.1136/bmj.h4633, 10.1136/bmj.h4679) provide valuable accounts of how the FDA is using faster reviews for what it deems to be important new drugs and using supplemental approvals for existing drugs more widely.1 2 This is just what patients and their doctors are said to want—more patients benefiting from taking more new drugs sooner, generating revenue for the companies to fund more breakthrough research.

Put in the context of the FDA’s larger record, however, these studies give cause for concern about whether most new drugs are any more effective …