Senior faculty from Johns Hopkins Bloomberg School of Public Health, Harvard Medical School/Brigham and Women’s Hospital, Yale Medical School and Yale Law School are calling for more transparency from the U.S. Food and Drug Administration to improve product safety.
The researchers collaborated to create the Blueprint for Transparency, 18 recommendations to improve transparency at the U.S. Food and Drug Administration (FDA) in five principal areas: application process, analysis and decision-making, review process, correction of misleading information, and data from scientific studies of medical products.
“FDA is more than an agency that makes regulatory decisions,” Dr. Joshua Sharfstein, professor of the practice at Bloomberg and former FDA Principal Deputy Commissioner, says in a press release. “It is also a repository for scientific analysis and data that, if more widely available, would improve understanding of existing therapies, the pharmaceutical pipeline and opportunities for innovative product development.”
Currently, the FDA does not disclose when a drug is being tested and Sharfstein and the other researchers suggest transparency at key steps of the process could benefit patients, doctors and researchers on progress of the testing.
Researchers also want the FDA to disclose why a product was not approved, which is not often disclosed by the companies who were denied FDA approval.
Another area researchers want to see more transparency in is disclosing which products are in the generic review process for generic drugs. This lack of transparency was apparent when Congress held hearings on the skyrocketing cost of EpiPens and FDA officials were not allowed to disclose if there were any applications filed for generic alternatives.
Researchers are also calling for quicker action and transparency from the FDA when a manufacturer releases information the FDA knows to be false or misleading.