Gaps, Tensions, and Conflicts in the FDA Approval Process: Implications for Clinical Practice

Richard A. Deyo, MD, MPH


J Am Board Fam Med. 2004;17(2) 

In This Article

Postmarketing Surveillance of New Products

Although user fees have facilitated preapproval evaluation of new drugs, the money cannot be used to evaluate the safety of drugs after they are marketed. Experts point out that approximately half of approved drugs have serious side effects not known before approval, and only post-marketing surveillance can detect them. But in the opinion of some, FDA lacks the mandate, the money, and the staff to provide effective and efficient surveillance of over 5000 drugs already in the marketplace.[24] Although reporting of adverse effects by manufacturers is mandatory, late or nonreporting of cases by drug companies are major problems. Some companies have been prosecuted for failure to report, and the FDA has issued several warning letters as a result of late reporting. Spontaneous reporting by practitioners is estimated to capture only 1% to 13% of serious adverse events.[25]

Widespread promotion of new drugs—before some of the serious effects are known—increases exposure of patients to the unknown risks. It is estimated that nearly 20 million patients (almost 10% of the US population) were exposed to the 5 drugs that were recalled in 1997 and 1998 alone.[26] The new law allowing user fees for device manufacturers does not have the same restriction on postmarketing surveillance that has hampered drug surveillance.