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Drs. Hamburg and Sharfstein: “The FDA as a Public Health Agency”

Wasting no time, Drs. Hamburg and Sharfstein have written an essay, entitled “The FDA as a Public Health Agency.” (Available on-line at: http://content.nejm.org/cgi/content/full/NEJMp0903764). Noteworthy in the new essay is the “big tent” approach they plan to use. They repeatedly refer to consultation with regulated industries, consumers, patients, and the public. They describe specific areas for working more with CDC, NIH, CMS, and the Department of Agriculture.

Drs. Hamburg and Sharfstein touch upon a potpourri of agency issues:

  • FDA should be judged by its success in assuring a safe and nutritious food supply and innovative, safe and effective medical products. This must go “beyond such intermediate measures as the number of facilities inspected or drugs approved.”
  • The potential good of a medical product or policy should be balanced against its potential harm. They add: “Some benefits are not worth the risk; some risks are worth taking.”
  • The focus of increased work with NIH should be on accelerating the development of cures. The focus of increased work with CMS should be the exploration of ways to shorten the time from approval to reimbursement.
  • The focus of increased work with CDC should be on infectious-disease emergencies, outbreaks of foodborne illness, enhanced safety systems, and nutrition.
  • A new approach to external affairs is foreshadowed by discussion of risk communication, more focus on the scientific basis of agency decisions, and greater transparency.

Both by words and tone, the overriding message of the Hamburg/Sharfstein article is that the FDA is a public health agency and will be run by the principles of public health as applied to the issues and opportunities facing the FDA. My May 15 commentary, “Public Health Leadership Comes to FDA,” (http://www.fdamatters.com/?p=211) puts some additional texture on this:

It is a perfect time to put the agency in the hands of experienced public health leaders with real world experience. The answer to every question and pressing issue: we will explore what is right from a public health perspective, and then act accordingly. Public health does not require safety to be an absolute value that cannot be offset by other considerations. Innovation to restore health is just as much a public health value as safety.

Dr. Hamburg and Dr. Sharfstein have limited track records on FDA issues. This uncertainty breeds anxiety. Six months from now, everyone will see that the agency is being run by steady, pragmatic leaders. Indeed, it is quite difficult to run the public health department of a large city without these virtues.

This NEJM essay demonstrates that having “limited track records on FDA issues” has not stopped Drs. Hamburg and Sharfstein from having a good sense of the issues and well-developed ideas about how to improve FDA. Ultimately, we, as readers, learn from the essay that Drs. Hamburg and Sharfstein have the knowledge and commitment to address the challenges faced by FDA.

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