July 11, 2006

The FDA is opposing substantive changes to its postmarketing policies despite a recent HHS Office of Inspector General (OIG) finding that the agency does not take its postmarketing review responsibilities seriously enough.

The OIG's report, "FDA's Monitoring of Postmarketing Study Commitments," concluded that the FDA is failing to ensure that companies meet their postmarketing responsibilities. The agency cannot readily identify whether or how timely postmarketing study commitments are progressing and these reviews are "not a top priority at FDA," the report found. The report, which was publicly released July 7, is available at: oig.hhs.gov/oei/reports/oei-01-04-00390.pdf (http://oig.hhs.gov/oei/reports/oei-01-04-00390.pdf).

Postmarket reviews are necessary to ensure that a drug is safe and effective because premarket studies are usually too limited to catch many of a drug's side effects. This is especially true for rare side effects, the report said.

The agency has faced growing criticism for its handling of Vioxx and other drugs, with critics arguing that the FDA review process is too slow and incomplete to catch potential problems.

The OIG found that 35 percent of the annual status reports (ASRs) drug applicants provided in fiscal 2004 were missing or incomplete. The agency also validated only 30 percent of these reports. Companies are required under the Food and Drug Administration Modernization Act of 1997 to submit ASRs that provide information on the status of these studies.

The OIG recommends that the FDA require that industry provide "additional, meaningful information" in their ASRs, improve its management of this information and ensure that these studies are being monitored and validated. However, the agency rejected the OIG's conclusion that the FDA cannot readily identify whether and how timely these studies are progressing. The agency also disagreed with the report's recommendation that the additional information be provided in the ASRs.

The agency lacks the regulatory authority to require additional information, the FDA said in a May 16 letter responding to the draft report. Current regulations have specific content and format elements. "A provision for additional information would require that new regulations be written," the agency said.

Numerous congressional critics of the FDA seized on the report as evidence of an agency in decline. "The Inspector General's report is the most recent assessment of the

Food and Drug Administration that shows the agency is a facilitator and not a regulator," Sen. Chuck Grassley (R-Iowa) said in an email.