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|
|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%|
|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%|