Commissioner addresses CSSP meeting
By George B. Corcoran, Past President, Society of
Toxicology
 One highlight of the CSSP winter meeting was an address given by Dr.
Margaret Hamburg, commissioner of the Food and Drug Administration. Hamburg was
confirmed in May 2009 by unanimous vote of the U.S. Senate as FDA Commissioner,
the second woman to serve in this capacity. She is a graduate of Radcliffe
College and Harvard Medical School who completed her residency in internal
medicine, pursued neurosciences and neuropharmacology research at Rockefeller
University and NIMH, and AIDS research as Assistant Director of the NIAID. She
served as Commissioner of Health for New York City where she emerged as a
leading public health innovator and advocate. She served as Assistant Secretary
of Planning and Evaluation at DHHS and is one of the youngest scientists to be
elected to the Institute of Medicine.
Hamburg's
remarks to the Council addressed two important challenges facing the agency and
the citizens of our nation. The first was the state of science at the agency and
regulatory sciences overall, and the second was the more recent concern over
conflict of interest of members of FDA committees advising on regulatory
decisions. The FDA is a crucial and unique science-based regulatory agency with
the mission of protecting public health, ranging to assuring safety of drugs,
vaccines, food and food additives, medical and radiation-emmiting products,
veterinary products, cosmetics, and the foods people eat every day. More than 25% of all consumer spending in the
US is on products regulated by the FDA.
For these great and important historic responsibilities, the agency has
under-appreciated and seriously underfunded. Despite attention that is turning
now to new challenges like the regulation of tobacco, the approval of novel
products from emerging areas of science, and expanded expectations brought on by
globalization, there is a growing sense at the agency that it is now beginning
to turn a major corner.
Medical review by FDA includes
product safety and efficacy as well as considerable post-marketing monitoring.
The science capability of the agency must be equal to this task. Currently, the
nation is not investing to keep pace in science, particularly in the regulatory
sciences. China plans to invest over $10B and the EU of over $5B, dwarfing those
of the US which is in the low $Ms. FDA
scientists need the knowledge, tools and professional stakeholder interactions
to support the agency in achieving its mission.
Dr. Hamburg reiterated that the US must increase its recognition of and
support for the regulatory sciences involving basic and applied research,
training, and cross-cutting multidisciplinary approaches. A successful agency is an important driver of
the US health, its economy, and its global competitiveness. FDA Chief Scientist,
Dr. Jesse Goodman, has been charged to increase scientific collaboration with
academia, industry, and agencies like NIH and CDC, to increase scientific
development of agency scientists, and encourage the creation of centers for food
regulatory sciences.
Hamburg
directed her remaining comments to FDA scientific advisory boards and
committees, and specifically addressed the issue of conflict of interest (COI).
The agency has 49 committees with over 600 members across a large number of
sub-specialty areas. Some committees
provide guidance and others the basis for agency regulations. FDA needs the best
experts to serve on these committees, but this is not always easy to achieve
because of extensive and time paperwork needed to satisfy appointment
requirement and the demanding workload on committees once appointed. The issue
of COI can be a challenge where the committee requires expertise in highly
technical areas where the number of true experts is small. The agency has
authority to grant COI waivers, but they can not exceed 13% of committee
membership. COI waivers are currently 5%. Hamburg acknowledged that use of
necessary COI waivers is controversial and can undermine confidence in the
agency. FDA has recently held many "listening" sessions with stakeholders
including patient and consumer groups, trade organizations, and others. When
asked for top issues with the agency, it was not avoiding COI but that it was
important to have the expertise at the table and to manage conflict
appropriately.
Appointing a committee member with a COI is a difficult judgment that is
made by senior agency officials who themselves are free of COI. While there are no absolute answers to the
issues of COI at this point, the agency welcomes feedback on how to move
forward. Two principles are driving current thinking: 1. Not all COI is equal
[example - an organization receives funding from a conflicted source but the
individual researcher on the committee should not be classified with a COI], and
2. Not all committees and meetings are equally sensitive to COI (example -
general advice versus regulatory approval committees). Disclosure is a crucial
part of managing COI, including why a committee member with a COI waiver is
essential for the capabilities of a committee and what avenues were exhausted
resulting in use of the member with the COI. The waiver process must be fully
transparent. Approaches discussed during
question and answer included non-voting status for COI members, and public
release of information on all committee members under the uniform disclosure
policy of the International Committee of Medical Journal Editors. Hamburg closed
her remarks noting the positive change in administration support of the
importance of science in advancing the FDA responsibility of ensuring the safety
and high quality of more than a trillion dollars worth of products that are
critical for the survival and well-being of all Americans.
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