FDA Halts Drug Advisory Committee Reviews
This article details a notable shift in how the FDA utilizes (or doesn’t utilize) its advisory committees – groups of outside experts traditionally consulted on drug approvals. Here’s a breakdown of the key points:
* Reduced Reliance on Advisory Committees: The FDA,under Commissioner Marty Makary,is holding significantly fewer advisory committee meetings. Numbers have dropped from 22 in a previous timeframe to only 7 recently.
* Shift to “Complete Response Letters”: Instead of seeking committee input, the FDA is now prioritizing the release of “complete response letters” - documents explaining why a drug submission was rejected. While transparency is good, experts argue this isn’t a substitute for open deliberation.
* Concerns about Bias & Transparency: The core criticism is that Makary is replacing vetted, independent advisory committees with panels of scientists he handpicks, who tend to share his views. This raises concerns about bias and a lack of genuine, independent review.
* Deliberation vs. Voting: There’s a suggestion that even if committees were used,simply deliberating without voting on products might be preferable to the current system. One expert reminisced about a past system they considered “amazing.”
* Traditional Role of Committees: Advisory committees historically served several vital functions:
* Reviewing important new drugs.
* Providing input on tricky decisions (like Aduhelm).
* Helping resolve internal disagreements within the FDA.
* Lack of Public Input: The new panels are frequently enough convened quickly, with limited opportunity for public review of materials or public comment. This further fuels concerns about transparency.
* Examples of Controversy: The article specifically cites the hormone replacement therapy panel, where Makary wanted a black-box warning removed and populated the panel with experts who agreed with him.
In essence, the article paints a picture of the FDA moving away from a system of independent, public review towards one that is more controlled by the Commissioner and potentially influenced by his pre-determined conclusions.