Advisory Committees review data on drugs to advise the FDA about what to do
For many years, the U.S. Food and Drug Administration (FDA), which is the United States' regulatory agency for medications, has had a process for their staff members to obtain official advice from professionals and others about specific products that the FDA is reviewing. It is done through expert groups, which the FDA call "Advisory Committees" (and which are sometimes nicknamed "AdComms"). These committees focus on a specific area; for those of us interested in diabetes, most of the Advisory Committee action is done by the "Endocrinologic and Metabolic Drugs Advisory Committee."
These committees include scientists and health professionals, as well as representatives from industry, consumers, and may also include a patient representative. The FDA sets up scheduled meetings for each Advisory Committee, gives the members documents to review, sets up presentations by FDA staff and the manufacturer of the product under review, and then asks the members to respond to and vote on specific questions that the FDA. After the committee makes recommendations to FDA, the FDA itself makes the final decisions, usually several weeks after the Advisory Committee meeting.
Announcements of the meetings of the various Advisory Committees are posted on the FDA website, at Advisory Committees. The 2009 calendar is available at 2009 FDA Advisory Committee Calendar. Also, you can sign up at the FDA website for updates on advisory committee meetings.
The nice thing about the FDA website is that old Advisory Committee information is retained, so you can go back and review what the FDA was thinking about a subject years ago. I've found the easiest way to look for old information is to Google it. Available information on the FDA website will include presentations (in PowerPoint format), questions the FDA asked the AdComm, and transcripts of the meetings. As an example, if you want to learn more about the discussions on the first glitazone drug, troglitazone (Rezulin), enter the following information at the search box at the FDA website:
The results of AdComms can be interesting. Earlier this month (April, 2009), the Endocrinologic and Metabolic Drugs Advisory Committee met to review two new diabetes drugs that drugmakers are seeking approval to sell in the US. Documents about these sessions may be found on-line at Endocrinologic and Metabolic Drugs Advisory Committee: April 1 and 2, 2009."advisory committee" troglitazone
On April 1, 2009, the Endocrinologic and Metabolic Drugs Advisory Committee voted 10 to 2 that the investigational diabetes drug saxagliptin does not put type 2 diabetes patients at an increased risk for cardiovascular events. But all voted "no" in response to a question about whether data were adequate; the committee felt further long-term, post-marketing cardiovascular studies including higher-risk patients were necessary.
The next day, the investigational diabetes drug liraglutide was discussed. While the panel felt that this drug was safe from a cardiovascular standpoint (the advisory panel voted 8 to 5 that liraglutide does not increase cardiovascular risks), there was a concern about thyroid cancer that was seen in animal studies. The committee voted 6 to 6 that the cancer data in animals were sufficient not to recommend approval.
Will the FDA approve these two new diabetes drugs? The FDA usually follows the advice of the AdComms, but it may or may not. They might ask the manufacturers to do more studies of the safety of either of these two drugs before they are approved, or might approve either or both, and ask for additional studies after approval, or turn down the applications completely. We shall have to wait and see.
