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FDA Final Rule: Drug Firms Must Promptly Report Risks or Adverse Reactions of Clinical Trials

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September 28, 2010

The U.S. Food and Drug Administration (FDA) has instituted new requirements for reporting risks or adverse reactions found during clinical trials of investigational drugs and biologics.

“This Final Rule will expedite FDA’s review of critical safety information and help the agency monitor the safety of investigational drugs and biologics,” Rachel Behrman, M.D, associate director for medical policy in the FDA’s Center for Drug Evaluation and Research said in a release. “These changes will better protect people who are enrolled in clinical trials.”

The new FDA rule requires that pharmaceutical companies or drug sponsors report certain safety information, which previously did not require reporting to the FDA, within 15 days of becoming aware of an occurrence. These reports include:

  • findings from clinical or epidemiological studies that suggest a significant risk to study participants
  • serious suspected adverse reactions that occur at a rate higher than expected
  • serious adverse events from bioavailability studies which determine what percentage and at what rate drug is absorbed by the bloodstream and bioequivalence studies which determine whether a generic drug has the same bioavailability as the brand name drug

“This final rule is expected to improve the quality of safety reports submitted to FDA, thereby enhancing the safety of patients in clinical trials,” the FDA said in the Final Rule. “The final rule lays out clear, internationally harmonized definitions and standards so that critical safety information about investigational new drugs will be accurately and rapidly reported to the agency, minimizing uninformative reports and enhancing reporting of meaningful, interpretable information.”

The definitions and reporting requirements in the FDA’s Final Rule are now more consistent with two international organizations, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and the World Health Organization’s Council for International Organizations of Medical Sciences. This is important because many pharmaceutical companies conduct clinical trials outside the U.S. and the FDA can now evaluate this safety information along with information from U.S. clinical trials.

The new FDA regulations come after public outcry and media stories regarding an inquiry into GlaxoSmithKline’s Avandia by the U.S. Senate Committee on Finance, who oversees the FDA, that found GSK knew of potential cardiac risks and failed to disclose those risks.

“Our report was based on a review of hundreds of thousands of pages of internal GSK documents and concluded: The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public.… Based on this knowledge, GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner. Instead, GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk,” said Senator Max Baucus and Senator Chuck Grassley in a the letter to Margaret A. Hamburg, MD, Commissioner of the FDA.