Advisory Committees – The Missing Links and The Vacancies

Every so often, I check in to see how the agency is faring when it comes to Advisory Committee transparency.  The last time I did a chart like this several months ago, CDER and CBER figured in for having about 80% of the CVs of Advisory Committee members linked.  As of this writing, the combined average is about the same – doing well, but not perfect.

The chart below will show only CBER and CDER to look at two things.  First, are there links to the CVs and backgrounds of committee members.  Prior to any advisory committee meeting, it is worth knowing who the people are who are advising the FDA – their expertise, their knowledge and their experience.  Second, the chart below will also give a read on the level of vacancies that need to be filled on each committee.

The vacancies are also an important element in planning for an Advisory Committee meeting because the more vacancies, the more “wild cards” that will figure into the equation.  By contrast, while most advisory committee members have their CVs linked, the advisors the FDA uses to fill slots that are vacant or to address specific expertise are not available and in fact, the names of the individuals may not be revealed until the FDA posts the documents for the meeting 24-48 hours prior to the meeting time.

The vacant rate among CBER committees is particularly high, with about one-third of all biologics positions being vacant.  CDER has proportionally fewer vacancies.   The FDA now has a FDA Track Dashboard set up for following advisory committee activity.  The numbers are only entered through 2010 and no 2011 numbers have been entered, but in terms of vacancies, it shows little movement.  In the fourth quarter of 2010, the percent of vacancies at CDER was 27%, 26% and 25% – while the target is a 10% vacancy rate.  At CBER, the goal is the same, but the percentage was 32% for each of the last three months of 2010.  Overall, the combined vacancy rate for all advisory committees was approximately 24%.  As the numbers add up both vacancies and CV links, that means that for AdComms, were are about three-fourths transparent.

Committee Number of Members Number of Vacancies Number of linked CV’s Percentage of committee memb with linked CVs
CBER 47 25 23 49%
Allergenic Products Advisory Committee 9 1 6 67%
Blood Products Advisory Committee 8 10 4 50%
Cellular, Tissue and Gene Therapies Advisory Committee 13 1 3 23%
Transmissible Spongiform Encephalopathies Advisory Committee 6 10 4 67%
Vaccines Related Biological Products Advisory 11 3 6 54%
CDER 175 56 153 87%
Anesthetic and Life Support Drug Advisory Committee 11 3 7 64%
Anti-Infective Drugs Advisory Committee 12 2 12 100%
Antiviral Drugs Advisory Committee 10 4 4 40%
Arthritis Advisory Committee 7 5 7 100%
Cardiovascular and Renal Drugs Advisory Committee 9 3 9 100%
Dermatologic and Ophthalmic Drugs Advisory Committee 13 3 13 100%
Drug Safety and Risk Management Advisory Committee 13 1 10 77%
Endocrinologic and Metabolic Drugs Advisory Committee 7 5 5 71%
Gastrointestinal Drugs Advisory Committee 10 2 10 100%
Nonprescription Drugs Advisory Committee 8 7 8 100%
Oncologic Drugs Advisory Committee 10 4 10 100%
Peripheral and Central Nervous System Drugs Advisory Committee 8 4 7 88%
Pharmaceutical Science and Clinical Pharmacology Advisory Committee 22 8 21 95%
Psychopharmacologic Drugs Advisory Committee 12 0 11 92%
Pulmonary-Allergy Drugs Advisory Committee 14 0 10 71%
Reproductive Health Drugs Advisory Committee 9 5 9 100%
TOTAL 222 81 176 79%
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