March 6, 2006

The FDA needs the ability to impose financial penalties as an incentive for drug companies to submit required annual postmarket study reports on time, according to a public advocacy group.

The recommendation by Public Citizen follows the release of an FDA report that showed half of the required postmarket reports hadn't been submitted as of Sept. 30, 2005. Most of these studies had not even been started. Sixty-five percent of the required brand and generic drug postmarket studies and 37 percent of the biologic product studies had not been started, the FDA said recently.

The FDA doesn't have enough authority to police these commitments, Peter Lurie, deputy director of Public Citizen's Health Research Group, told FDAnews. "The only thing the agency can do is take the drug off the market, which is a decision that often would not serve the public health very well," he said. "[The FDA needs the] authority to fine these companies heavily for each day they are late."

The agency has never withdrawn a drug from the market because a company has not completed the required safety and other postmarket studies, according to John Jenkins, director of the FDA's Office of New Drugs. The FDA also does not impose civil or criminal penalties for late filings of postmarket data, he added. In a "really serious case," the FDA would consider withdrawing the drug from the market, Jenkins said.

Lurie said companies fully understand the FDA will never pull a drug off the market, so they keep violating the requirements. "The great majority of postmarketing studies address safety issues, at least in part, so patients and physicians are denied critical safety information when these studies are not completed in a timely fashion," he said.

Lurie also criticized the FDA's report on the status of postmarketing commitments, noting there is no way of knowing what the deadlines are for each stage of the commitment and if they are being met or not.

Jenkins explained the FDA sets the schedule for firms to complete a battery of studies on products that require a postmarket study. The agency then evaluates each study to see if the drug company has fulfilled the requirements of the study commitment. If the company fails to submit data on time, the commitment is considered delayed, Jenkins said. The agency has been setting commitment schedules for the last four or five years, he added.

The reports must contain information on the status of each FDA-required study for clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology. The firm must continue to submit the report until the FDA determines that the commitment has been fulfilled or that the agency no longer needs the reports.

PhRMA cautioned the data in the FDA's report should not be "distorted."