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FDA Should Stay Out of Health Care Reform

When the new NIH director, Dr. Frances Collins, was interviewed by the New England Journal of Medicine, he stated that one of his priorities is to: “put science to work for health care reform.” I hope that Dr. Hamburg isn’t having similar thoughts about involving FDA in health care reform.

Health care reform is our nation’s #1 health priority. It does not lack for attention, participation and debate. Hundreds of billions of dollars will be driven by the outcome. However, our country will not be better off if every health-related agency diverts its attention and finite budgets to the cause.

I have been watching NIH for more than 30 years. All NIH directors have had the same goal: keep NIH and its biomedical research mission out of politics. Some directors have done this by pretending politics doesn’t exist. Others have protected the agency by being consummate politicians. Both strategies have been successful at different times and in the hands of different directors.

I do not remember any NIH director openly welcoming politics into the agency.

The NEJM interviewer asked Dr. Collins’ whether NIH will become politicized if it takes an active role in health care reform. He responded:

That is always a risk. I am exploring this. I don’t know the answer precisely. I do think the idea that NIH’s responsibility for trying to influence public health ends at the point of running a clinical trial and publishing the results may be a little narrow for the climate that we are in. While we are a research organization, and that’s always going to be our focus, maybe there is more opportunity now…..”

“Putting science to work for health care reform” will politicize NIH. This will not be good for biomedical research…or for America’s patients who are waiting for treatments and cures. I hope Dr. Collins’ comes to this realization quickly and does not let NIH get distracted.

This same point applies equally to FDA. The agency’s plate is full with mission-appropriate responsibilities, including implementation of its new authority over tobacco. More work is coming through food safety reform, follow-on biologics and other administrative and legislative initiatives.

The new FDA leadership has made a strong point that science, not politics, should be the basis of FDA decisionmaking. To this, we can all say: bravo! Involving the agency in health care reform guarantees that politics will creep into the agency’s activities and conclusions.

Getting involved in health care reform may be trendy….but it will be destructive, if not disastrous, for FDA. The agency needs to stay on mission and out of health care reform.


Dr. Collins’ NEJM interview can be found at: http://healthcarereform.nejm.org/?p=1808&query=TOC.

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