It Girls and Beyond
FDA: Drug Safety (last updated January 24, 2005) (back to top)
In defending a doctor charged with illegally prescribing a drug that was not approved by the Food and Drug Administration, Denny Crane and Alan Shore attack the FDA for being too slow in approving new drugs and cite recent criticism by a FDA researcher that the FDA does not do enough to test a drug's safety once the drug has been approved.
First, the FDA has been criticized in recent months for whether the drug Vioxx should have been pulled from the market sooner. Vioxx was voluntarily withdrawn from the market by its manufacturer in September 2004, though FDA researcher David Graham has testified that the FDA could have acted sooner if not for an organizational structure that prioritized new drug approvals over post-approval safety.
Graham testified in a Nov. 18, 2004 hearing that the Vioxx case was "a profound regulatory failure" and that the "FDA, as currently configured, is incapable of protecting America against another Vioxx." He argued that the FDA and its Center for Drug Evaluation and Research are "broken" because the office that evaluates post-marketing safety, the Office of Drug Safety, has no regulatory power and because the office responsible for taking any post-marketing regulatory action is also the one that approves drugs for marketing, the Office of New Drugs.
FDA officials have criticized Graham's arguments, saying that the Office of Drug Safety is already independent and separate from the Office of New Drugs. FDA officials have also defended the safety of five drugs that Graham cited during the Nov. 18 hearing as having safety issues that warranted further scrutiny.
Nonetheless, the FDA has announced new measures to strengthen its post-marketing surveillance program. On Nov. 5, it announced that it would study the effectiveness of the drug safety system, formalize a program to better incorporate scientific reviewers' opinions, and finalize guidelines to assist manufacturers in managing risks involved with drugs.
Second, the FDA also has long been criticized for not approving drugs fast enough and has taken some steps over the years to accelerate the process. For example, in the 1980s, the FDA ended AZT drug trials early and took steps to make AZT available to AIDS patients; it also issued new regulations codifying the circumstances in which investigational agents were given to seriously ill patients not to gain information about safety and effectiveness but for treatment. Since the 1990s, Congress has also passed legislation that charged drug manufacturers fees so that the FDA could hire more reviewers and speed up the review process.
The following graph shows the total median approval time in months for priority and safety drugs approved by calendar year, based on FDA data available here:
Sources: The FDA has information about Vioxx's withdrawal on-line here. Information about the Senate Finance Committee's Nov. 18, 2004 hearing in which David Graham testified is on-line here, and Graham's opening statement is on-line as a PDF here. The FDA has statistics about new drug approval times here and has information about the Prescription Drug User Fee Act on-line here.
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By Stephen Lee
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