FDA 2011 Regulatory Climate: Cloudy, With a Chance of More Regulation

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Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Last year we put on our weather forecaster’s hat and called for greater FDA enforcement of medical devices in 2010. For the most part, I’d argue we got that right.

Unfortunately for us amateur prognosticators, 2011 is looking cloudier – and weirder. While the FDA has sent some signals that it intends to take enforcement matters more seriously, we have also seen the agency behaving a bit oddly when it comes to its efforts to improve 510(K) regulation and make the agency more “transparent” to John Q. Public.

Let’s take a look at some of the FDA’s Greatest Hits of 2010:

  • The Kids Think They Are Alright: It’s not the year’s biggest issue by a long shot, but the dismissal of several senior media experts and their replacement by Young Turks with little or no FDA-related experience does suggest the FDA may be getting more political and less interested in real science. While hope springs eternal, this doesn’t bode well for an open or especially skilled department in 2011.
  • Cloudy Transparency: A clumsy FDA attempt to tout transparency when no one was watching oddly-timed “transparency” news release from the FDA isn’t really the best time to tell the world you want to open up and apply tougher metrics on your performance. Still, that’s just what the FDA did with an August 31, 2010, release touting its new “organizational performance management system” called FDA-TRACK. It promised to monitor FDA accountability and transparency and will monitor more than 100 FDA program offices through data from key performance measures established each year. Just don’t tell anyone.
  • CDRH Likes Itself: For the year, CDRH gave what kids in school would consider a B+ with an 86% completion rate in a new report, the Center for Devices and Radiological health says it accomplished 86 percent, or 92 of 107 actions it pledged to complete in Fiscal Year 2010.
  • 510(k) Regulation is Either Onerous or Marvelous: An AdvaMed funded report from Stanford sparked controversy –and a testy FDA response – when it concluded that device companies pay a heavy price in terms of time and money when it comes to FDA compliance. That’s the well-researched and well-argued thrust of the big study from Stanford that also said American firms and consumers were at a disadvantage compared to those in Europe. The debate on the cost and hurdles for medical device regulatory compliance will certainly continue into 2011.
  • Hamburg Talks Tough. A new FDA report suggests the agency is trying to get some of its regulatory swagger back after budget cuts and brain drains hampered much of its work in the George W. Bush years. In October, FDA Commish Margaret A. Hamburg M.D., said the agency proposes to build on what it calls the success of the Critical Path Initiative and other projects by leading an effort to advance regulatory science through its new Regulatory Science Initiative.

All in all, it looks like the FDA is still struggling to find its identity as we enter 2011. Will it become a more aggressive, strident regulatory agency? Will it slip back into relative lethargy? Worst scenario: Will it become more aggressive with less experienced inspectors and other professionals at the helm?

Watch this space in 2011.

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    Recently, it does seem like the F.D.A. is attempting to move in the right direction with their scrutiny of the production of metal-on-metal hip implants. For more information regarding their recent action, which was termed by F.D.A. official Dr. Maisel to be the “broadest” use of the company’s authority to regulate products already approved for sale, check out http://medicaldevicerecall.com. I hope this is one of many steps on the F.D.A.’s road to better regulation.

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