When Transparency is Easy – Advisory Committee Transparency

With respect to the workings of the FDA Advisory Committees, last August the agency issued a heap of guidance and statement to make more apparent potential committee conflicts of interest and issued new standards.  But in fact, information about the committee members has been harder, not easier to come by.

It used to be that when you went to the FDA Web site to look at a particular advisory committee, there would be hotlinks from the name of the committee member that took you to their CV.  In this way, one could learn a great deal about the committee as a whole – determining their research backgrounds and associations that can be very informative when a sponsor is bringing a presentation before the committee – sponsors who, by the way, pay a good deal in user fees to support the regulatory process.  And such information was particularly useful for the media when the Reproductive Drugs Advisory Committee was found to have several ultra-conservative members when considering Plan B for OTC approval.  Then, the makeup of committee rosters was very transparent.  

But today, if you visit the roster pages of the Advisory Committees, here is what you'll see:

• Anesthetic and Life Support Drugs Advisory Committee – 10 members, no links;
• Anti-Infective Drugs Advisory Committee – 14 members, 13 links;
• Anti-Viral Drugs Advisory Committee – 13 members, no links; 
• Arthritis Drugs Advisory Committee – 8 members, 6 links; 
• Cardiovascular Drugs Advisory Committee – 12 members, 11 links; 
• Dermatologic and Ophthalmic Drugs Advisory Committee -  8 members, no links; 
• Endocrinologic and Metabolic Drugs Advisory Committee – 10 members, 5 links; 
• Gastrointestinal Drugs Advisory Committee – 6 members, no links
• Non Prescription Drugs Advisory Committee – 12 members, 2 links
• Oncologic Drugs Advisory Committee – 13 members, 9 links; 
• Peripheral and Central Nervous System Drugs Advisory Committee, 7 members, 6 links; 
• Pharmaceutical Science and Clinical Pharmacology Advisory Committee – 9 members, 9 links
• Pharmacologic Drugs Advisory Committee – 11 members, 1 link 
• Pulmonary Allergy Drugs Advisory Committee – 13 members, 9 links 
• Reproductive Drugs Advisory Committee -  10 members, 5 links  

And this is just looking at CDER.  Of the 143 sitting members of CDER Advisory Committees, there is only information available about for about half of them – specifically 78 of them.  That's not very transparent.

Some of the time, transparency is about putting into force new standards, new regulations, calling for public meetings and starting blogs.  But sometimes, transparency is about the doing the simple things that you should be doing all along and it doesn't necessarily require all that hoopla.  It isn't necessarily about setting up new systems of transparency – it is about fixing the old ones.