FDA Task Force proposes to make more drug, device information public

The FDA Transparency Task Force is proposing that the FDA should make more information available to the public about a number of actions it takes, such as reasons for refusing to approve drugs and medical devices.

The task force Wednesday released 21 draft proposals for changes in FDA policy related to the disclosure of information. Under the proposals issued by the task force, the agency would be required to publicize rejection letters for new drugs and devices, as well as the reasons for the rejection.

For example, according to one of the draft proposals, the FDA would be required to disclose the fact that it had issued a “not approvable” letter in response to a pre-market approval application for a medical device, or that the FDA issued an “additional information” letter in response to a 510(k) submission. At the same time, it would have to release those letters—which contain the reasons for issuing the letters—to the public.

In an article published online Wednesday in the New England Journal of Medicine, Afia K. Asamoah, JD, director of the FDA’s Transparency Initiative, and Joshua Sharfstein, MD, the FDA’s principal deputy commission and chair of the Transparency Task Force wrote that if the proposals are adopted the FDA “would make substantially more information about the regulatory process available to the public.”

They also wrote the task force believes the implementation of some of the proposals will accelerate the medical product development process by allowing companies to learn from the successes and failures of other products.

For example, they point out that one proposal allows the FDA to explain that an orphan drug whose application has been withdrawn or abandoned for some reason still may have some therapeutic value for patients with a rare disease.

“This information would be of substantial interest to patients with that disease, their families, and their clinicians,” Asamoah and Sharfstein wrote. “It could also encourage additional investment for development of that drug or provide another company with the incentive to purchase and continue with the application."

The task force is also recommending that the FDA:

• Expand online public access to adverse event reports;

• Make public or confirm the existence or nonexistence of investigational applications;

• Disclose when the FDA receives a new drug, biologic or device application;

• Release safety and effectiveness summaries from pending applications in some cases;

• Disclose when the U.S. Department of Justice seeks enforcement action on the FDA's behalf;

• Release information about recalls as soon as practicable after receiving information from the firm involved, as well as inform the public as soon as a recall has been terminated; and

• Post on its website warning or untitled letters to individuals or firms notifying them of the Federal Food, Drug and Cosmetic Act.

The proposals will be published in the Federal Register on May 21 and the FDA will accept public comments on them for 60 days. The publication culminates an 11-month long process that began when the FDA formed the task force in June 2009.