Intended for healthcare professionals

Feature Regulating New Approaches to Medicine

FDA faces regulatory challenges with new approaches to medicine

BMJ 2014; 348 doi: (Published 14 February 2014) Cite this as: BMJ 2014;348:g1530
  1. Bob Roehr, journalist
  1. 1Washington, DC, USA
  1. BobRoehr{at}

Bob Roehr looks at how medicine is changing and what it means for the regulators

The US Food and Drug Administration (FDA) faces unprecedented regulatory challenges not just with new products but with entirely new fields of activity that are likely to transform medicine in the decades to come. Among them are stem cell therapies, commensal microbial transplants, and personalized genetic testing. They are rapidly evolving and much remains unknown, or at least not definitively proven.

That uncertainty plays to the tension between emphasizing safety and affording opportunity for treatment that is at the core of the agency’s responsibility. Another often less apparent tension playing out is that between regulating interstate commerce, which is the legal basis for FDA authority, and the practice of medicine, which, to the extent that it is regulated, is the responsibility of state government.

The FDA regulatory paradigm historically is the model of infectious disease where a single drug targets an invading pathogen. Once that invader is neutralized, the body reverts to a normal state. But these new fields are characterized by the complexity of the intervention itself and its effect on the patient. The agency is struggling to understand and adapt to these new interventions.

Genetic testing services

One example occurred in November 2013 when the FDA told 23andMe to stop marketing its direct to consumer genetic testing services.1 It said that the company had failed to provide information necessary for approval and that consumers might misinterpret the information provided.

The company’s response, in an email to their clients, suggested that the FDA should have used a different regulatory pathway. It hinted that the disagreement was fundamental, not amenable to compromise, and might need to be resolved through the courts.

It is “a culture clash between Silicon Valley, with its devotion to libertarianism and self-knowledge, and …

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