STAT+: FDA publishes rejection letters sent to drugmakers, with a big caveat

The Food and Drug Administration on Thursday published more than 200 letters that it sent to companies when it rejected their medicines, focusing attention on what’s often an opaque part of the drug review process.

The agency only highlighted letters that went to drugmakers whose products were eventually approved, most of which have already been made public over the years. But by compiling all the letters into one place, the agency said the move was part of a broader campaign aimed at improved transparency. Some portions of the letters, which cover decisions made from 2020 to 2024, were redacted to safeguard private business details. 

At least 14 of the letters were published for the first time, the FDA told STAT.

Continue to STAT+ to read the full story…