(Reuters) -The U.S. Food and Drug Administration released more than 200 of its so-called complete response letters from its archive on Thursday, in a push to increase transparency under Health Secretary Robert F. Kennedy Jr.
The health regulator typically sends such letters to drugmakers whose treatments are not approved, detailing reasons and whether additional data is required.
The letters were published in response to applications received between 2020 and 2024, the FDA said, adding it was in the process of sharing more letters from its archive.
Kennedy has promised “radical transparency” at the agency and has been vocal in his criticism of the FDA, accusing its staff of doing the bidding of Big Pharma and Big Food.
“No more guessing games. Developers, investors, and patients deserve to see how we make decisions,” FDA Commissioner Marty Makary said in a post on social media platform X on Thursday.
Historically, companies have exercised discretion on what information from the CRL is shared with investors.
Companies avoided mentioning 85% of FDA’s safety and efficacy concerns in their statements about the CRL, according to a 2015 analysis conducted by FDA researchers.
Lessons learned from non-approvals are also not shared within the industry, leading companies to repeatedly make similar mistakes, the FDA said.
Trade secrets and confidential commercial information were redacted from the letters before they were publicly shared, the agency said.
(Reporting by Bhanvi Satija in Bengaluru; Editing by Tasim Zahid and Sriraj Kalluvila)
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