One of the major complaints levied against FDA by the current administration is that the approval process is too complicated, takes too long, and needs to be modernized. The new leadership pledged to take various steps to rectify this and improve the drug approval process.
Key Takeaways
- FDA published over 200 complete response letters.
- These letters were published as part of the agency's goal of promoting transparency.
- Current FDA leadership says that sponsors would previously mislead stakeholders about the reasons for FDA's decision.
What steps is FDA taking to promote transparency?
Another element that the administration claims to be focused on is transparency. In an effort to promote this, FDA leadership issued a statement announcing the publication of over 200 complete response letters.1 According to the agency, these letters were sent in response to applications filed between 2020 and 2024.
The agency also stated that the letters will be publicly available in order to promote transparency.
In a press release, FDA commissioner Marty Makary, MD, MPH, said, “For far too long, drug developers have been playing a guessing game when navigating the FDA. 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.”
The statement continues to explain that, according to current FDA leadership, sponsors would misrepresent to their stakeholders the reasons why FDA failed to approve an application and would avoid mentioning the majority of the agency’s concerns for safety and efficacy.