Harvard Drug Study of FDA Deadlines Finds Increased Recalls

Recalled pharmaceutical drugs such as Vioxx, Bextra, Rezulin, and Baycol all were approved by the United States Food and Drug Administration (FDA) under speedy approval deadlines enacted in 1992 according to a Harvard study published in today’s New England Journal of Medicine. The New England Journal Article discusses the deadlines enacted in 1992 that required FDA approval of drugs within 12 months for most drugs submitted by pharmaceutical companies for sppedy approval and within 6 months for drugs designated as high priority for potentially life saving benefits. The speedy approval deadlines for most drugs was tightened to 10 months in 1997. Under the 1992 legislation the drug companies paid millions of dollars to the FDA for the speedy approval and the FDA was financially penalized if the drugs were not approved on schedule. This created a financial incentive for the FDA to approve a drug that might not be safe for the public in my opinion.
Harvard professor Daniel Carperter found that approval of drugs was 3.4 times more likely in the two months before the user fee deadline than at any other time. The study also found that drugs approved in the just before deadline time frame had a four to five fold rate of later being withdrawn or requiring additional later safety warnings.
This New England Journal article raises important public policy questions about the wisdom of the current FDA speedy approval rules that subject the FDA to financial penalties if it delays approval of a drug that may have a public health risk.