The US Food and Drug Administration (FDA) has published a database containing over 200 letters to pharmaceutical companies detailing why the agency initially refused to approve their products. The move, described as “radical transparency,” sheds light on an obscure aspect of drug development.
The database includes complete response letters, which outline problems with experimental drugs that cannot be remedied and were previously not made public. The letters detail concerns about safety and efficacy issues, manufacturing facility inspections, and other problems discovered during the review process.
According to experts, the move aims to provide predictability for pharmaceutical companies and investors. However, some notable rejection letters have been absent from the database, including those related to drugs that were never approved.
One example is the testosterone drug Jatenzo, which was initially declined due to its potential to increase blood pressure and raise major heart problems. The agency eventually approved the product with prominent warnings after new data showed similar cardiovascular risk among men with low testosterone using the gel compared to a placebo.
The FDA database is seen as a step towards greater transparency in the approval process, but critics argue that more information should be released, especially for drugs that were rejected due to safety concerns.
Source: https://www.nytimes.com/2025/07/10/health/fda-drugs-letters.html