The Association of Clinical Researchers and Educators (ACRE) today announced its support for reforms to the Food and Drug Administration’s (FDA) conflict of interest standards. ACRE strongly recommends that FDA adopt new policies that ensure experts with the highest scientific and clinical qualifications are actively recruited to serve as advisory committee members.
The FDA regulates more than 150,000 marketed drugs and medical devices, with nearly 3,000 investigational new drugs being developed at any given time. These advances offer hope for patients and the opportunity to improve public health, which must be balanced against the potential risks.
Although FDA employees have extensive scientific and medical training and experience, they cannot alone encompass the full range of expertise necessary to evaluate the increasingly complex minutiae associated with medical innovation. The agency therefore looks to outside experts to serve on technical and scientific advisory committees that evaluate the safety and efficacy of experimental products. Advisory committees provide crucial independent advice to assist with regulatory decision-making processes and support sound decision-making by the FDA.
In 2007, new conflict of interest standards were adopted that set an arbitrary financial threshold for committee participation. Experts with personal or family financial interests above $50,000 are excluded from serving as committee members, and even if conflicts are resolved, they must wait at least one year before being permitted to serve. Those with interests below the threshold are allowed to serve, but are stripped of their voting rights.
Since adoption of these new policies, committee vacancy rates have steadily increased. The most recently released data for overall FDA committee membership from the third quarter of 2010 show vacancy rates ranging from 25% to 27%. The Center for Biologics Evaluation and Research (CBER) vacancy rates are markedly worse, reaching 32% for the last three months of 2010.
“These rising vacancies clearly demonstrate the unintended consequences of overly restrictive conflict of interest policies,” stated Michael Weber, MD, a Director of ACRE, “Both government and industry rightfully seek out accomplished leaders in many fields for their expertise. Excluding a portion of these leaders because they have collaborated with industry to promote advancements in science and health is hindering the FDA’s ability to meet its responsibilities to patients. Product reviews are unnecessarily delayed along with patients’ access to new therapies and medical devices.”
Data obtained by both critics and supporters of industry collaboration consistently reveal that industry consultants are often the most qualified and prominent physicians and productive researchers. Moreover, detailed analysis of FDA panels’ recommendations reveals no effect of industry relationships on panel members’ voting behavior.
“Advisory committee members should be chosen based on their direct experience with, and expert knowledge of, the specific technology under review,” stated Weber. “ACRE supports a transparent evaluation process under which remuneration from for-profit and non-profit entities is examined and made available to the public. Relationships that indicate direct financial interests with an entity whose product is the subject matter of a particular Advisory Board meeting would reasonably lead to recusal of a potential advisor.. Other interests, including so-called perceived conflicts, should not be used as exclusion criteria.”
“We urge the FDA to further scrutinize the impact its current conflict of interest policy is having on product reviews and approvals and make the appropriate adjustments.”
The Association of Clinical Researchers and Educators (ACRE) is a non-profit professional organization of medical professionals dedicated to the advancement of patient care through productive collaboration with industry and its counterparts. ACRE seeks to define and promote balanced policies at academic medical centers and within government that will enhance rather than interfere with our highly valued collaboration. In addition, ACRE will identify and train next generation of researchers and educators.