FDA Commissioner Martin Makary says the agency will begin publishing drug rejection letters long kept confidential to help developers better understand what he calls the FDA's "black box."

Washington

The US Food and Drug Administration (FDA) has announced it will start publishing its drug rejection letters, which have previously been kept confidential. FDA Commissioner Martin Makary stated that this initiative is intended to provide greater transparency and guidance for drug developers, helping them understand the reasons behind the agency's decisions.

Makary explained that drug companies have often been able to 'spin' the FDA's feedback, sometimes downplaying the extent of required changes or additional trials. By making rejection letters public, the FDA aims to eliminate confusion and help the industry make faster progress in developing effective drugs.

The FDA's push for 'radical transparency'

Drug developers and inventors of new drugs are trying to figure out, how do they get through this long, gnarly regulatory process? Well, we can be more transparent. We can provide better communications. We can provide guidance. We can answer questions on demand. And we are announcing that we're going to make our decision letters public so that drug developers can see why drugs are not accepted at the FDA. Why weren't they public? Some of the drug companies don't want them public. We learned that most companies will spin the results from the FDA. The company will not even say that the FDA is asking for a new clinical trial when we've asked for a new clinical trial in our decision letter. So there's an opportunity for companies to sort of spin the results, make it sound like, oh, the FDA got it back to us. And they just want to see one small tweak. If, in fact, there's more disclosure about letters that say, we're not approving your drug, could that help the rest of the industry make progress faster on developing the right drug? Absolutely. Look, we need more transparency. The FDA has been a black box. And companies have scratched their heads to try to figure out, what do the reviewers want? Why are they rejecting a drug? Did they actually reject it with a big rejection or just ask for a small modification? Well, no one's known because none of this has been public information. Well, that's going to change.

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