The FDA has a total of 33 Advisory Committees, 17 of which are focused on Drugs and 5 of which are focused on blood, vaccines and other biologics. For our purposes today, we are going to focus on those dedicated to drugs – see how well we are doing on keeping track of vacancies (remember, FDA is almost always looking for people to serve on an AdComm) and on transparency – specifically the ability to understand the range of expertise on the committee by knowing the background of the members.
Vacancies. Recruiting qualified experts to serve on advisory committees who do not have conflicts of interest has got to be one monumental job. As such, there are frequently vacancies and in fact, there have been times in the past where a committee could have more vacancies than members.
By last count per the FDA Track dashboard, there was a 13 percent vacancy rate (the goal is 10 percent) as of March 2015 (the date it was last updated) – and it has generally hovered around that number for many months.
Vacancies are important for a couple of reasons – first there may be good candidates for filling the vacancies and second because companies that will have drugs up for consideration before the committees generally like to know the makeup of the committee before a meeting. While there can always be added consultants to a committee meeting, having too many vacancies introduces a wild card element to the proceeding.
Here is a list of the committees that have current vacancies. Unfortunately, you will see two sets of numbers. The first number is the number of vacancies that are listed on the individual roster of each of the Advisory Committees, which you can see by clicking on the individual link/while the second number is the number of vacancies listed on the page FDA maintains to overview vacancies on the advisory committees. It is also interesting to note that while the roster page for the Non-Prescription Drugs Advisory Committee states that there are zero vacancies, where the name of the Chairperson should be is the word “Vacant” – so the body of the roster differs from the heading of the roster.
As you will see, there is frequent disagreement between the two sources of advisory committee information on vacancies making it uncertain as to exactly how many vacancies exist at present :
- Anesthetic and Analgesic Drugs AdComm – 0/0
- Antimicrobial Drugs AdComm (formerly Anti-Infective) – 2/5
- Bone, Reproductive & Urologic Drugs AdComm – 2/5
- Cardiovascular and Renal Drugs AdComm – 4/4
- Drug Safety and Risk Management AdComm – 1/1
- Endocrinologic and Metabolic Drugs AdComm – 1/1
- Gastrointestinal AdComm – 0/0
- Medical Imaging AdComm – 1/4
- Non-Prescription Drugs AdComm – 0/4
- Oncologic Drugs AdComm – 1/2
- Peripheral and CNS Drugs AdComm – 0/0
- Advisory Committee for Pharma Science – 3/4
- Pharmacy Compounding AdComm – 0/0
- Pyschopharmacologic Drugs AdComm – 5/2
- Pulmonary-Allergey Drugs AdComm – 0/1
In the end, determining the vacancies on committees appears to depend where you go for the information on the FDA site.
Transparency. The rosters for each of the AdComms not only provides us with the list of who is (and who is not) on the committee, but it also contains links to the curriculum vitae of each member. Usually.
For the sake not only of transparency and assessment of conflict of interest, but also again because companies should know the makeup and background of the committee before whom they are going to appear, the information should be readily available to the public. In the distant past, there were high numbers of members who did not have such links, sometimes comprising half of a committee. The numbers are much better, but the links are still not universal. Here is where there are deficits:
- Cardiovascular and Renal AdComm – 3 unlinked members
- Dermatologic AdComm – 2 unlinked members
- Drug Safety and Risk Management – 3 unlinked members
- Oncologic Drugs AdComm – 2 unlinked members
- Pharmaceutical Science AdComm – 3 unlinked members
- Psychopharmacologic AdComm – 1 unlinked member
As far as providing transparency – FDA is doing a much improved job over the past, but still has some work to do.
Keeping up the FDA website has to be a great big job to coordinate – there are so many moving parts. And these may seem like a few small issues, but for the sake of accuracy, credibility and transparency when it comes to the drug approval and monitoring process, they are worth noting and worth fixing.