Drugs regulators are revisiting the conflict-of-interest rules that have raised the complaints of some critics who believe that the rules overly restrict who can serve on drug advisory panels. The advisory panels are made up of outside experts who consult about drug approvals and other FDA decisions. The FDA is not required to follow the advisory panel's recommendations, but often does.
WHAT ARE FDA COMMITTEES?
There are 49 committees and panels that advise the FDA, and more than 600 members serving on the panels. Each panel deals with a certain area of expertise. The committees provide independent advice on the approvals of drugs and medical devices, and also on general drug policy matters.
WHO IS ON FDA COMMITTEES?
The panels are made up of scientific experts such as doctors and biostatisticians. The advisers must be able to analyze complex scientific data and "understand its public health significance."
The committees also have a consumer and patient representative, as well as an industry representative who can't vote, but are present for advice and inquiries.
LEGAL GUIDELINES FOR FDA PANELS
The panels are governed by the Federal Advisory Committee Act, which applies to all government agencies. The rules try to ensure that the population, as a whole, is represented. This includes women, minorities, those with disabilities, and individuals living in different geographic regions of the country.
Each potential member of the committee must provide information about financial holdings, employment, research grants and contracts, and any other potential conflicts of interest which could hinder participation. Unfortunately, critics doubt that the FDA can discover a violation of the rules if someone decides to hide a potential conflict.
WHAT ARE FDA PANEL WAIVERS
Currently, panel members with financial ties of over $50,000 to a drugmaker or a competitor are not allowed to serve on a panel for that company. Those with smaller financial ties may still advise on the drug - though the agency must justify the move in a waiver letter, which must be approved by the FDA.
Federal guidelines cap the number of waivers the agency can use. In 2010 the agency waived about 13 percent of panel applicants. This figure is expected to diminish over time.
HOW THE FDA FINDS PANELISTS
Professional societies, industry, consumer and patient advocacy groups, along with the FDA itself, can nominate panel members based on their expertise. People can also self-nominate. Nominees must go through a vetting process for conflicts of interest and scientific expertise, after which they can serve on a panel for up to four years.
REASONS FOR BEING A PANELIST
All advisory members become "Special Government Employees" and get a salary for each meeting day, as well as travel expenses and daily costs. Many panel members have stated that the salary rarely covers the hardship of frequent, possibly cross-country, trips, the lost salary at regular jobs, and the need for extensive preparation ahead of each meeting.
But there are benefits to serving on a panel besides cost. Serving as an FDA panelist can often boost an individual's credibility and resumé, even though many members are already established experts in their field, and do it simply to have a more direct effect on medical practice.