Download 0302320.01 - American Bar Association

REPORT
The ABA Section of Business Law and the Section of Administrative Law & Regulatory
Practice submit this report recommending the appointment of a Commissioner of Food and
Drugs. Please note that these views are being presented only on behalf of the Sections of
Business Law and of Administrative Law & Regulatory Practice. They have not been approved
by the House of Delegates or the Board of Governors of the American Bar Association and
should not be construed as representing the position of the American Bar Association.
George W. Bush was elected to the office of President of the United States in November
2000. Shortly after he assumed office in January 2001, he asked for and accepted the resignation
of the existing Commissioner of Food and Drugs, Dr. Jane Henney. Since that date in early
2001, the U.S. Food and Drug Administration (FDA) has been without a Commissioner to lead
it. The White House has nominated no candidate for this important public position in nearly 20
months in office; one-half of the term of the Bush Administration.
FDA has broad legal and regulatory responsibility as a component of the United States
Public Health Service and the Department of Health and Human Services (HHS). It has been
estimated that FDA oversees products that constitute $0.25 of every dollar spent by the
American consumer. The discovery, testing, manufacturing, marketing and sale of these
products constitutes over one-quarter of the American economy. Products regulated by FDA
include: all processed foods (with the exception of beef, eggs and poultry that are regulated by
the U.S. Department of Agriculture), medical foods, dietary supplements, bottled water and
beverages, tableware, food additives, food packaging and contact materials, infant formulas,
prescription drugs, generic drugs, over-the-counter medicines and consumer health care
products, cosmetics, animal drugs, biologics, the blood supply, medical devices, all devices
which emit radiation (e.g., lasers, light bulbs, cellular telephones, TVs, microwave ovens, etc.),
kitchens on airplanes, trains, cruise ships, etc. Agency inspectors are also responsible for
monitoring, sampling and testing all foreign products imported into the United States. They also
are responsible for inspecting all manufacturing facilities that produce or process the products
highlighted above in the U.S. and abroad.
In addition, as government resources and priorities shift to protecting the country from
bioterrorism, FDA has become the designated lead agency in promoting and testing new antibacterial and antiviral agents. The Agency’s mission is to insure that vaccines, antibiotics, other
pharmaceuticals, gas masks and other devices are developed, tested, manufactured, packaged,
distributed, marketed, prescribed, and used safely and effectively by American consumers. The
borders must also be policed to insure that tainted or contaminated products are not imported into
American commerce.
The Agency’s enormous jurisdiction and responsibility for our public health requires
strong and independent leadership. FDA’s resources are extremely limited for the scope of its
jurisdiction (approximately $1.2 billion per year to fund slightly over 10,000 employees) in five
regions, 21 districts and 130 resident inspection posts throughout the U.S. Therefore, the
Agency’s top leader must carefully prioritize its use of resources while modernizing surveillance
apparatus and keeping current with a revolution in life sciences. The disparate constituencies
served by this important agency require that the FDA Commissioner be a respected scientist,
clinician, scholar, manager, politician and diplomat. It is not often that there is agreement among
consumer advocates, patients, physicians, hospitals, contract research organizations,
manufacturers, other health agencies, states, the Congress, White House and the media.
The Administration, or Department of HHS, has floated the names of approximately a
dozen qualified individuals for the position of Commissioner. None of the proposed candidates
has achieved universal support from the Presidential Personnel Office, the Department of Health
and Human Services, and the Chairman of the Senate Health, Education, Labor and Pensions
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June 26, 2017 4:23 PM
Committee. The majority of the prior Commissioners have been physicians who came from
academia as deans of universities or medical schools.
In the interim, the Administration appointed two senior officials to FDA, neither or
whom required Senate confirmation. Dr. Lester Crawford, a veterinarian, former Director of
FDA’s Center for Veterinary Medicine and Director of the Virginia Tech Center for Food and
Nutrition Policy was appointed as Deputy Commissioner. Dan Troy, a partner at Wiley, Rein &
Fielding and former law clerk to Judge Robert Bork was appointed as General Counsel.
The ABA Committees designated above, which are composed of experts in food and drug
law who regularly interact with FDA, HHS, the White House and the Congress believe that it is
essential to nominate and confirm a qualified FDA Commissioner as expeditiously as possible to
meet the following objectives:

Restore leadership; direction; innovation to FDA;

Establish accountability;

Upgrade FDA representation in senior Administration policy circles;

Strengthen employee morale; confidence; dedication; retention;

Create legitimacy;

Reevaluate field interpretations of company good manufacturing practices;

Restore consistency between product centers; field investigations;

Bring Centers together;

Reduce unduly conservative risk-adverse decision-making;

Expedite and prioritize reviews; resources;

Make hard decisions;

Create certainty in chain-of-command; end internal leadership squabbles;

Create confidence; certainty in marketplace; and

Reshape and more clearly define the Agency for the benefit of the public and regulated
industry.
For these reasons, the Committee seeks the support of the Sections in taking a public
position on behalf of the Sections among policymakers to expedite the process used in selecting
a FDA Commissioner.
Respectfully submitted,
Section on Business Law
Committee on Food, Drug and Cosmetic Law
Marc J. Scheineson-Chair
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Section on Administrative Law
Committee on Food and Drug
I Scott Bass-Co Chair
August 9, 2002
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