The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency.
The attempt may have created more questions, however, with only certain letters shared and some documentation provided happening outside of the four-year timeframe the FDA said the CRLs occurred during. Many also contain redactions, with some covering multiple paragraphs and large sections of the letters.
According to the federal agency, the letters are responses to applications submitted to the FDA for approval of drugs or biological products between 2020 and 2024. However, certain CRLs shared occurred far outside this range, such as a 2008 rejection for Kyowa Kirin’s istradefylline—now sold as Nourianz—for Parkinson's disease "off" episodes. The drug received approval in 2019.
The agency did not respond to questions regarding the timeframe discrepancies.
All of the CRLs are for drugs that have since gained approval from the agency, a Department of Health and Human Services spokesperson told Fierce Biotech.
“FDA has previously disclosed some CRLs as part of approval packages. Those that were previously disclosed were scattered and hard to find. Now, we are centralizing it,“ the spokesperson said. “The FDA is working to make more decision letters public, with appropriate redactions of confidential commercial information and trade secrets.”
The release comes after years of back-and-forth within the agency itself and the broader industry over making the rebuffs public.
“By making the CRLs available, the public now has significantly greater insight into the FDA’s decision-making and the most common deficiencies cited that sponsors must address before their application is approved,” the agency said in a July 10 release.
CRLs are rejections to a drug approval request and can be issued for numerous reasons, such as safety or efficacy concerns, manufacturing deficiencies and bioequivalence issues. The agency letters list the deficiencies for the sponsor and sometimes include recommendations for addressing the problems.
Historically, the FDA hasn’t publicly released the rejection letters. Sponsors are not legally required to share the details with the public.
“Sponsors often misrepresent the rationale behind FDA’s decision to their stakeholders and the public,” the FDA said in today’s release.
An HHS spokesperson declined to comment when asked for specific examples of sponsors misrepresenting FDA reasoning.
“For far too long, drug developers have been playing a guessing game when navigating the FDA,” FDA Commissioner Marty Makary, M.D., said in the release. “Drug developers and capital markets alike want predictability. So today we’re one step closer to delivering it to them, with an ultimate goal of bringing cures and meaningful treatments to patients faster.”