The FDA's amendments to the waiver has made it easier for those with financial COI to participate on advisory committees. According to Wood and Mador, "...waivers are granted if one of the following is true: the COI is unlikely to 'affect the integrity of the services,' (ii) the 'need for the individual's services outweighs the potential for a COI,' or (iii) they will contribute 'essential expertise." It is arguable that (ii) should, instead, read as follows: 'the need for the individual's services outweighs the potential for a COI to influence behaviors,' as the existence of the waiver already assumes that that COI are present and need to be waived for the individual with COI to serve of the FDA advisory committee.
The FDA has also stated that experts who have financial COI in excess of $50,000 may not participate on advisory committees. In addition to the ambiguity of the term "may not," there is research that suggests that even small gifts, such as drug company pens with logos, have been positively associated with physicians feeling increased senses of loyalty to the sponsoring company (see literature on physicians receiving industry gifts below). According to an FDA guidance statement, the waivers and disclosed COI must be available on a publicly accessible website. Furthermore, unlike other health institutions that require the disclosure of all COI, the FDA requires that only financial relationships and COI within the past 12 months are relevant.
The 2007 FDA Amendments Act (FDAAA) instituted "caps" on the number of COI waivers that the FDA is able to grant. The 2012 FDASIA removed this restriction and, although COI must be publicly disclosed, an unlimited number of waivers can be granted. Among others, an implication here is that many, if not all, members on an FDA advisory committee may possess financial COI with a drug company and influence the agency's decisions to benefit industry. The move to weaken the 2007 policies that protected the public against COI within the FDA was calculated and responded to lobbying by industry-supportive groups.
A viable alternative to continually using mostly conflicted experts and instituting waivers to allow conflicted experts to sit on FDA advisory committees is finding nonconflicted experts. A study cited in the article by Wood and Mador found that 42.7% of a population of academic life science researchers had no conflict of interest relationships with industry. This study concluded that although it may be difficult to find nonconflicted scientists to serve on FDA advisory committees, it is not impossible and should be considered, especially when the health of the population is at stake.
Uncapping Conflict of Interest?
Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
Doctors, Drug Companies, and Gifts
Physicians' Behavior and Their Interactions with Drug Companies: A Controlled Study of Physicians who Requested Additions to a Hospital Drug Formulary
Who pays for the pizza? Redefining the relationships between doctors and drug companies. 1: Entanglement
A Social Science Perspective on Gifts to Physicians From Industry
Drug Companies & Doctors: A Story of Corruption
Book: The Truth About Drug Companies: How They Deceive Us and What To Do About It
All Gifts Large and Small
Attitudes of Physicians and Public to Pharmaceutical Industry ‘Gifts’