FDA Proposal Would Provide More Info on Drugs in Development

The Food and Drug Administration (FDA) is considering a series of proposals that would provide physicians and consumers with more detailed information about drugs that are in the development stages and still pending approval.

Joshua Sharfstein, MD, the FDA’s principal deputy commissioner and chair of the agency’s transparency task force, explained that the proposals would “help consumers, stakeholders and others understand the agency’s operations and decision making—all while balancing the need for transparency with manufacturers’ desire to protect their proprietary information.” The proposals were published in the Federal Register and are currently open for a 60-day comment period that ends July 20. When this period ends, Sharstein and the rest of the task force will review the comments and choose which proposals should be recommended to FDA Commissioner Margaret Hamburg, MD.

The first phase of the FDA’s “transparency initiative” was launched last summer by Hamburg, during which the FDA reached more than 1,500 comments. These comments served as the basis for this summer’s draft proposals.

If the proposals are adopted, according to Sharfstein, the FDA would be able to disclose when a drug or medical device is being studied and what possible uses it could have. The new proposal would also allow the FDA to disclose “when an application for a new product has been submitted or withdrawn, whether there were safety concerns associated with a product that led to withdrawal of an application, and why the agency did not approve an application.”

Sharfstein used an orphan disease as an example of how the proposal could be beneficial. If a drug aimed at treating an orphan disease is withdrawn or terminated by a sponsor for business reasons, the FDA would then be allowed to clarify that the application was not withdrawn because the product was unsafe or defective, should the new proposal be adopted. This type of knowledge could encourage other companies to continue research on the product, possibly opening doors to a new treatment for an orphan disease.