US FDA publishes 200 complete response letters from archive in transparency drive
The U.S. Food and Drug Administration on Thursday publicly shared over 200 archived so-called complete response letters related to medicines that were later approved, in a bid to improve transparency under the leadership of U.S. Health Secretary Robert F. Kennedy Jr.
Kennedy has promised “radical transparency” at the Department of Health and Human Services, which oversees the FDA, and has previously been vocal in his criticism of the agency, accusing its staff of doing the bidding of Big Pharma and Big Food.
Typically, the FDA sends the letters, or CRLs, to drugmakers whose treatments are not approved, detailing reasons and whether additional data is required, but companies have historically exercised discretion on what information from the CRL is shared with investors.
The letters published on Thursday were issued in response to applications the FDA had received between 2020 and 2024, the agency said, adding it was in the process of sharing additional letters.
The FDA cited a 2015 analysis, which concluded that companies avoided mentioning a majority of the safety and efficacy concerns highlighted by the FDA, and instead published “incomplete substitutes” for the CRL details.
Lessons learned from non-approvals are also not shared within the industry, which leads to companies repeatedly making similar mistakes, the FDA said.
“The policy justification that (the) FDA is offering will invite challenge by one or more sponsors (applicant companies) or possibly a trade association,” said health policy lawyer Paul Kim, citing the scale and the unprecedented nature of the decision.
Kim also said that some information from the published letters may have been previously disclosed in response to Freedom of Information Act requests, but it was difficult to determine the details of the same.
HHS did not immediately respond to a Reuters request asking if the companies whose letters were published were given a prior notice.
Piper Sandler analyst Biren Amin said that the letters could help investors gain better insights into the FDA’s review process.
“Since CRLs are now publishable, sponsors may feel more pressure to be transparent when disclosing approval failures,” Amin said.
Trade secrets and confidential commercial information were redacted from the letters before they were publicly shared, the agency said.
