Researchers create a set of recommendations for transparency at the agency in five principal areas.
As the new administration considers the future of the FDA, a group of researchers is calling for greater transparency at the FDA in a viewpoint article recently appearing in JAMA.
Joshua Sharfstein, MD, professor of the practice at the Bloomberg School, and Michael Stebbins, PhD, of the Laura and John Arnold Foundation, have created recommendations to advance the development of safe and effective new products at the agency. The full report, “Blueprint for Transparency at the U.S. Food and Drug Administration,” is being released simultaneously.
“The FDA can support evidence-based practice and innovation in product development by becoming more transparent,” says Sharfstein. “A number of academic experts decided to pull together a set of recommendations in one place.”
The report makes 18 recommendations in five principal areas:
1. The FDA should disclose more information about key milestones in the application process. Currently, the FDA does not disclose when a drug is being evaluated; transparency at key steps could help shed light on progress through the therapeutic pipeline for a wide range of medications, informing patients, doctors and researchers.
2. The FDA should disclose more of its own analysis and decision-making. The FDA does not explain why products are not approved, and companies often leave out important reasons in their public communications. Greater disclosure would help guide drug development to more promising areas.
3. The FDA should disclose more about the application and review process for generic drugs and follow-on biologics. Disclosing which products are in the generic pipeline can help more companies make decisions to enter the market and lower prices for consumers, according to the researchers.
4. The FDA should correct misleading information in the market. In some cases, manufacturers have released information the FDA knew to be false or misleading, but the agency waited months to correct the record. When there is potential for confusion about the safety or efficacy of a medical product for both approved and unapproved uses, the FDA should help to clarify matters.
5. The FDA should disclose data from scientific studies to enhance understanding of medical products. When manufacturers have not already done so, the agency should make de-identified data from all clinical trials used to approve or reject a drug available for other researchers.
“Managed care executives should know that greater transparency at FDA means more data and analysis to inform smart policy,” Sharfstein says. “They should be supportive of transparency efforts by FDA.”