FDA Urged To Increase Transparency of Drug, Product Review Process
FDA should publicly disclose more information regarding drug evaluations, food manufacturing inspections, and products' safety and efficacy, according to a report released on Wednesday by the agency's Transparency Task Force, Reuters reports (Heavy/Richwine, Reuters, 5/19).
The recommendations are part of a broader effort to improve the agency's public image, which has been criticized for being too slow to release information on potential safety issues. The panel recommended 21 strategies for FDA to release more information (Perrone, AP/Philadelphia Inquirer, 5/19).
The task force -- which included FDA's top lawyer and researcher, as well as directors of its device, drug and other departments -- recommended that FDA:
- Disclose letters to companies detailing why a product was not approved or why an application was rejected;
- Announce when a firm's proposed drug application was terminated, withdrawn or placed on hold; and
- Release pending applications' safety and effectiveness summaries if there is a public health interest.
If adopted, the changes could increase public awareness of FDA's review process and affect companies' ability to control negative information that might be detrimental to their financial interests, such as product denials.
While many companies and industry groups have said they support increased transparency by the agency, many also have argued that disclosing too much data could jeopardize the product development process.
Ken Johnson, senior vice president of Pharmaceutical Research and Manufacturers of America, in a statement urged FDA to "continue to protect proprietary information."
It is unclear how FDA would release such information or how quickly it could begin doing so.
Although the recommendations stated that "trade secrets should remain confidential," it also is uncertain how much information the agency could block from public view.
FDA Commissioner Margaret Hamburg ultimately will decide which recommendations to adopt, though the agency still must determine whether it has the legal authority and the resources to carry out the proposals.
FDA will accept public comments on the suggestions until July 20 (Reuters, 5/19).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.