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Where health care policy experts have their say
Sources of Medical Research Funding
December 19, 2008:
Barack Obama's candidate for FDA commissioner will inherit an agency facing enormous challengesincluding implementing the FDA Amendment Acts of 2007, policing food and drug imports, and keeping the agency abreast of rapidly changing science in everything from genomics to nanotechnology. In the next administration, what do you think the next commissioner's top priorities should be?
This edition of our expert panel includes:
I. Miller is a research fellow at the Hoover Institution, where
his research focuses on public policy toward science and technology. Miller
joined the Food and Drug Administration in 1979 and was the medical reviewer
for the first genetically engineered drugs evaluated by the FDA, a special
assistant to the FDA commissioner, and the founding director of the FDA's
Office of Biotechnology. Since joining the Hoover Institution, Dr. Miller
has become well known not only for contributions to scholarly journals
but also for articles and books that make science, medicine and technology
more accessible to nonexperts. His most recent book was The Frankenfood
Myth: How Protest and Politics Threaten the Biotech Revolution (Praeger
* * *
"The Bush Administration erred in restricting embryonic stem cell research. Eventually, stem cell research probably will create new therapies. Press reports indicate that the Obama Administration will quickly reverse this decision, and that is a good thing. But it will not instantaneously lead to miracle cures.
Stem cell research would not be the first priority to create new therapies because it takes years for basic research to lead to new drugs. There are numerous drugs in development that could lead to major benefits much more quickly than anything developed from stem cells. Anything the FDA can do to reduce the costs and delays in creation, approval and marketing of new drugs will lead to more new drugs more quickly, both from stem cells and from other sources.
These policies would include speeding the approval process for new drugs; allowing advertising and promotion of drugs, both to physicians and to consumers; and continuing the recent policy of advocating FDA approval as preempting state tort lawsuits (although this depends more on the Supreme Court and Congress.)
In a Democratic Administration there will be pressures to require more testing of new drugs and to restrict promotion, but the head of the FDA should do all in his (her) power to resist these pressures if our goal is more and better drugs and improved health."
H. Rubin is Samuel Candler Dobbs Professor of Economics and Law
at Emory University in Atlanta and editor in chief of Managerial and Decision
Economics. Dr. Rubin has written or edited eleven books, and published
over one hundred and fifty articles and chapters on economics, law, regulation,
and evolution. He has consulted widely on litigation related matters and
has been an advisor to the Congressional Budget Office on tort reform.
* * *
"The most difficult but valuable pharmaceutical policy for the new administration will be to resist the temptation to impose price controls. Price controls promise lower prices but the cost is fewer new drugs and diminished medical progress. Moreover, the promise is illusory. Since new drugs typically lower total health care costs (by reducing time in hospital) price controls will raise total health care costs. Prizes and patent buyouts, two innovative ways of reducing pharmaceutical prices while maintaining incentives to develop new drugs, should be investigated and tested.
The FDA should continue to move away from a paternalistic model and towards a Consumer Reports model. CR does not ban products, it provides information. The FDA should make it easier for patients and their physicians to compare drugs, evaluate tradeoffs, and make choices based upon an individual patient's preferences and circumstances.
The FDA's new Sentinel system can improve post-market surveillance. Post-market surveillance, however, is most likely to succeed when it is seen as a resource for patients and physicians and not as a threat to pharmaceutical manufacturers.
In short, the FDA's vision should be to encourage innovation, empower patients and enhance personalized medicine."
an associate professor of economics in the department of economics at
George Mason University. He is also research director for The Independent
Institute and a research fellow with the Mercatus Center. His research
interests include empirical law and economics (tort reform, bounty hunters,
judicial electoral systems etc.), voting theory and alternative political
institutions, health economics (especially the FDA) on which he has written
number papers. He is the co-author of an extensive website on the FDA,
and the editor of a number of books.
* * *
"In selecting the next FDA commissioner, President-elect Obama can signal determination to achieve the promise of personalized medicine. The FDA must be grounded in science; that means the new Commissioner must have deep knowledge of science and public health and must make that the foundation for all decisions. The agency must have a leader with strong management skills; a leader who will remain apolitical and who will exercise a level of independence, akin to that of the Federal Reserve chair.
The new Commissioner cannot succeed without a strong agency behind him
or her. The FDA requires double its current resources just to fulfill
its congressionally mandated responsibilities, and its workload will only
grow as it strives to assure safety and maintain a flow of potentially
life-saving new products.
is the president of Research!America. Woolley is an elected member of
the Institute of Medicine and a fellow of the American Association for
the Advancement of Science (AAAS), she is a Founding Member of the Board
of Associates of the Whitehead Institute for Biomedical Research. Woolley
has served as president of the Association of Independent Research Institutes
(AIRI), as editor of the Journal of the Society of Research Administrators,
as a reviewer for the National Institutes of Health and National Science
Foundation, and as a consultant to several research organizations. Woolley
has a 25-year editorial and publication history on science advocacy and
research related topics. She is a sought-after speaker and is frequently
interviewed by science, news and policy journalists.
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