FDA Reviewers Question Drug Safety Process
Reuters reports that some FDA reviewers are concerned about the agency’s drug safety system. The antibiotic Ketek, manufactured by Sanofi-Aventis, was the focus of discussion during a recent FDA oversight of safety hearing. Ketek has been linked to liver failure and has recently undergone labeling changes (see this pdf now provided by the manufacturer) because the drug is too risky to treat mild infections. Lawmakers are concerned about the lack of post-marketing drug studies and have discussed measures to improve the FDA’s ability to monitor drug safety. Suggestions include:
- “Establishing an independent office to monitor adverse events once drugs are approved; and
- Granting the FDA authority to force drug makers to complete post-marketing approval studies.”
See also: Observers Argue About Whether FDA Found Teeth in Drug Approval Process.
February 14, 2007 Related topics: Legal & legislative, Quality, Safety, Errors, Pharmaceuticals