Recent Second Opinion:

Post-Election Predictions for Obamacare
November 11, 2010

Improving the FDA's REMS Program
August 05, 2010

Are Foreign Clinical Drug Trials Safe?
July 08, 2010

FDA's Bad Ad Program
June 03, 2010

Obesity and Public Health
May 05, 2010

The Route to Reconciliation
March 05, 2010

Conflict of Interest
January 28, 2010

Analyzing the Healthcare Bills
November 18, 2009

President Obama's Plan for Reform
August 24, 2009

The Healthcare Reform Debate
July 23, 2009

Priorities for the New FDA Commissioner
December 19, 2008

PhRMA's New Marketing Code
August 28, 2008

Personal Genetics Testing
July 29, 2008

Where health care policy experts have their say
June 13, 2008

Sources of Medical Research Funding
April 24, 2008

Off-Labeling Marketing
March 17, 2008

Second Opinion:
Where health care policy experts have their say

December 19, 2008:
Priorities for the New FDA Commissioner

Barack Obama's candidate for FDA commissioner will inherit an agency facing enormous challenges—including 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:

• Henry I. Miller, Research Fellow at the Hoover Institution
• Paul H. Rubin, Samuel Candler Dobbs Professor of Economics and Law at Emory University in Atlanta and editor in chief of Managerial and Decision Economics
• Alex Tabarrok, Associate Professor of Economics at the George Mason University
• Mary Woolley, President of Research!America

Priorities for the new FDA Commissioner
By Henry I. Miller

• Regulatory reform. Several recent developments at the FDA will further increase the already-excessive time and costs of drug development. The FDA needs to streamline its regulatory procedures and requirements, and the agency's senior and mid-level managers must be made more accountable for their decisions—especially those that delay the availability of new drugs, vaccines and medical devices to patients in need of them.
• Excessive risk-aversion. The culture of excessive risk-aversion throughout the FDA must be changed—which will require the commissioner to take significant political heat.
• Effective management. The FDA's own professional staff can frame the issues and options, so the function of the agency head should be primarily to manage the far-flung empire and to make the final decision on difficult policy questions. In addition, the commissioner must enforce the agency's ethics rules by reining in rogue officials who make public statements that conflict with FDA policies and decisions.

Henry 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 Publishers, 2004).

Please Create Incentives for New Drugs
By Paul H. Rubin

"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."

Paul 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.

Encourage Innovation, Empower Patients, Enhance Personalized Medicine
By Alex Tabarrok

"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."

Alex Tabarrok 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, FDAReview.org, and the editor of a number of books.

Federal Reserve Chair: A Model for FDA Independence
By Mary Woolley

"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.

According to recent public opinion surveys, Americans expect breakthroughs in the next decade in diabetes, cancer and heart disease, yet 57% believe we are not making enough progress. Americans deserve an FDA that is fully funded and armed with the leadership and vision to meet public expectations for research."

Mary Woolley 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.