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Dr. Collins Meet Dr. Hamburg

FDA and NIH should be working together more closely and productively. For this to occur, Dr. Hamburg and Dr. Collins need to bless a higher level of cross-agency commitment. The critical next step is a publicly announced meeting of the two to develop and advance a common agenda.

In an earlier column, I concluded that FDA and NIH are natural allies, with closely-related purposes as public health agencies. They share a similar worldview that medical and scientific knowledge should be derived from random clinical trials.

Subsequently, I wrote a column about the cultural and organizational barriers to a closer working relationship between NIH and FDA. I urged Commissioner Hamburg to meet with Dr. Collins to start breaking down those barriers.

Dr. Collins was interviewed in last week’s New England Journal of Medicine and stated his five priorities:

  • integrating new technologies to make basic research more productive;
  • translating basic research into clinical applications;
  • science in support of health care reform, notably comparative effectiveness;
  • global health; and
  • reinvigorating the NIH-oriented research community through support for more young researchers, more innovation-oriented grant review panels, and a stable and predictable funding trajectory for biomedical research.

These are appropriate priorities for NIH, but not reassuring to me as an FDA advocate.

Dr. Collins knows that most NIH-driven medical advances can’t go “from bench to bedside” except through FDA. Yet, he only mentions FDA once in the interview—to observe that the FDA has put the only clinical trial involving stem cells on hold. Although cooperation on this trial is a good thing, NIH and FDA need a broader, deeper and longer-lasting set of activities and goals.

Undoubtedly, NIH and FDA representatives are discussing how their new bosses can work together within the new Administration. This is necessary and useful, but not sufficient to dramatically improve the relationship between the agencies.

I am clamoring for something that is more public than emissaries feeling each other out.

The two agencies working together are powerfully synergistic….and boundless in the benefits they could bring to the American people by joining forces. The involvement of NIH Institute Directors and FDA Center Directors is essential to building a better, more productive relationship. But it will never happen if it requires them to overcome cultural and tribal impediments that keep resource-maximizing organizations from fully sharing responsibilities, decisions and monies.

Unless Drs. Collins and Hamburg personally create the expectation of cooperation at the highest levels, there will be little movement at the center/institute level. Only Dr. Hamburg and Dr. Collins can set the proper tone, provide guidance and break down the barriers. I previously asked Dr. Hamburg to meet with Dr. Collins.

Now, I urge Dr. Collins to meet with Dr. Hamburg. Please.


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

My two earlier columns on this topic:

FDA and NIH: Natural Allies
June 12th, 2009 http://www.fdamatters.com/?p=299.

Dr. Hamburg Meet Dr. Collins
July 12th, 2009 http://www.fdamatters.com/?p=366.

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