ADRs: Report Faults FDA, Recommends Mandatory Reporting
In a study released yesterday, federal investigators report that the FDA has failed to adequately track dangerous reactions and side effects caused by prescription medicines and recommend that the agency adopt a mandatory reporting system for adverse drug reactions (ADRs). Investigators found that the FDA is not aware of the full scope of the ADR problem because it has "no quality control system" in place to evaluate the frequency of side effects and the risks they pose, the New York Times reports. The study, issued by the Department of Health and Human Services inspector general's office, recommends that hospitals be required to report serious drug reactions in order to participate in Medicare and Medicaid, noting that under the current voluntary reporting system, providers routinely fail to pass on ADR information. A mandatory reporting rule would require approval from HCFA. The FDA has already begun to take some steps to improve ADR tracking, the report notes (Stolberg, 12/15).
LA Times Blasts FDA, Too
Meanwhile, the Los Angeles Times today criticized the agency for failing to pull the diabetes medication Rezulin from the market despite evidence linking the drug to sudden liver failure and death in patients. The Times suggested that the FDA has become "too responsive" to pharmaceutical companies and questioned why regulators are reluctant to ban the drug, which has generated $1.7 billion in revenue for manufacturing giant Warner-Lambert (Willman, 12/15).