The FDA published a database containing more than 200 letters to pharmaceutical companies detailing why the agency initially refused to approve their products, The New York Times reported July 10.
FDA officials described the move as a form of “radical transparency.” The documents, known as complete response letters, outlined early concerns about drugs that were eventually approved. Letters about products that were never approved were not included.
“For far too long, drug developers have been playing a guessing game when navigating the FDA,” said Marty Makary, MD, the agency’s commissioner, in a statement to the Times. “Drug developers and capital markets alike want predictability.”
HHS spokesperson Andrew Nixon acknowledged that many of the letters were public already, but said it is the first time a centralized database has been made available.
A review of the letters addressed to companies showed that they often revolved around problems discovered in manufacturing facility inspections and others outlined concerns about drug safety or effectiveness.
One letter showed why the agency initially declined to approve testosterone drug Jatenzo, then being developed by company Clarus Therapeutics. The letter said the drug could increase blood pressure, raising the risk of major heart problems and concluded that the drug’s risks outweighed its benefits.
