November 3rd, 2011

FDA Approves TAVR But Remains in the Crosshairs

I participated in the panel that recommended approval of the Sapien Transcatheter Heart Valve (THV) for patients with inoperable severe aortic stenosis: so-called transaortic valve replacement (TAVR).

The recommendation for approval was based on (a) the perceived strength of the results of the PARTNER study; (b) collaboration and support of the Society of Thoracic Surgeons and the American College of Cardiology; and (c) a commitment to create a national registry for post-marketing studies.

I was surprised — perhaps naively — by the wide range of opinions regarding the FDA process.

In the past several weeks, the FDA was blasted by a former Food and Drug Administration deputy commissioner for taking too long to approve the THV, and a group of senators introduced the Medical Device Regulatory Improvement Act, seeking to streamline FDA’s pre-market device oversight by directing the agency not to ask companies for more data than it needs.

Simultaneously, in a JAMA piece, Harlan Krumholz recommended a new industry model that encourages more — not less — scrutiny of study results.  Specifically, Harlan called for:

  1. An external coordinating organization (an academic center) to contract with the medical device manufacturer, which agrees to provide access to all of its source material (i.e., patient-level clinical research data), post-marketing studies, and safety programs
  2. The coordinating organization to contract with two qualified groups to conduct independent reviews of the data
  3. A steering committee, consisting of subject-matter experts as well as patients, investigators, and policy makers, that is selected by the coordinating organization to provide oversight and guidance.
  4. All data to be made available by the coordinating organization to other investigators

A recent NEJM opinion piece acknowledges that the FDA has been “simultaneously faulted for inadequate assurance of safety and efficacy and for suppressing innovation.”

You can’t have it both ways.  So which is it?

Does the FDA need fewer rules and a more streamlined process, or does it need additional oversight?  Which best serves our patients? 

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