Why Doesn’t FDA Publicly Disclose All NDAs and BLAs? Researchers Discuss
Although current regulations prohibit the US Food and Drug Administration (FDA) from publicly disclosing new drug applications (NDAs) and biologics license applications (BLAs), a new JAMA Internal Medicine research letter reasoned that the agency should consider more transparency, because almost all NDAs and BLAs are publicly disclosed by their sponsors.“We found that information that the FDA treats as confidential with regard to applications for NDAs and BLAs was in most cases already available to the public and that the disclosure rate in 2016 was 97.6%. Most disclosures took place in press releases, SEC filings, or both and occurred within 1 week of application submission,” the letter says.
The letter also notes a 2010 FDA report recommending that such NDAs, BLAs and other information, such as complete response letters (CRLs), be disclosed by the agency.
Similarly, a viewpoint published last July in JAMA Internal Medicine called on FDA to release clinical study reports (CSRs) and CRLs, and FDA said in January 2018 that it would release partially redacted CSRs. But so far, only the CSR for Janssen’s Erleada (apalutamide) has been released.
And former FDA Commissioner Scott Gottlieb also said an FDA official was reviewing about 100 CRLs to see if a subset could be released with redactions. But the agency has not revealed anything further on this end.
In an editor’s note accompanying the JAMA research letter, Robert Steinbrook of the San Francisco School of Medicine adds: “Disclosing basic information about the filing of marketing applications would be a long overdue and modest advance for an agency that has not been known for its embrace of transparency.”
JAMA Research Letter