FDA Report on Faulty Device Approval


Medical device safety and the FDA are in the news again. One of the first posts I wrote for the Blog was “FDA Hit With Yet Another Negative Report.” And there it was, top of the fold on the front page of the New York Times, and many other papers across the country, “F.D.A. Admits Role of Politics In Safety Case.” The article was on FDA leadership ordering the approval of Menaflex, a medical device, over the objections of FDA scientists. But this time is different. This time the report didn’t come from an outside investigation. This time it came from FDA.

faulty medicl device FDA

FDA Discusses Device Approval Process

The Times wrote, “The agency has never before publicly questioned the process behind one of its approvals, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.”

That certainly is my experience. I first joined FDA in November 1987 as a temporary under assistant support staff making Xerox copies of inspection reports to be redacted for release under the Freedom of Information Act. I was hired in January 1988 and worked for the next 17 years (and three days) and not once saw FDA publicly admit they made a mistake (I left in January 2005). Not once. Trust me. during that period FDA made many mistakes (some of them by me).

Now it seems that new commissioner, Dr. Margaret Hamburg and the new principal deputy commissioner Dr. Joshua Sharfstein, have a different approach. I personally saw Dr. Hamburg speak at the annual meeting of RAPS (Regulatory Affairs Professionals Society) and discuss FDA’s shortcomings (see previous posts). And as a result of the FDA report on the approval of Menaflex, Dr. Sharstein said the following:

“The message here is that there were problems with the integrity of F.D.A.’s decision-making process that have solutions.”

I have never heard an FDA leader say anything remotely like that before. And Dr. Sharfstein is not just concerned with FDA’s problems; he actually wants to fix things. My personal opinion is that things are changing at FDA. Dr. Hamburg and Dr. Sharfstein certainly have my attention. And they have my support. FDA needs significant, meaningful change to fulfill its public health mission. It looks like the agency has two determined leaders to begin that process.

When I first joined FDA the agency would always state that we were a science-based agency. It will be better for patients, industry, and the public at large if once again we can make that an accurate statement.

UPDATE: Here is a comment from the Blog’s very own book reviewer, Sid Olufs:

Yes, fascinating report, deserves to be read closely. OK Times stories yesterday and today, but here is the line I found worth copying from the report: “Our ability to assess the effect of these departures on the decision-making process was in many cases undermined by the failure of important decision-makers to sufficiently explain and document the bases for their decisions in an administrative record. This failure constitutes a clear deviation from the principles of integrity used in this review and undermines the ability of the agency to counter the suggestion that lobbying on behalf of ReGen affected the decision.” I think you are right, Carl. Yet I find it troubling that integrity depends entirely on who does the appointing of top officials. No set of rules guarantees integrity, but the political lines of authority here make it too uncertain. More independence, tighter mission, seem in order.

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2 Responses to FDA Report on Faulty Device Approval

  1. sid olufs says:

    Yes, fascinating report, deserves to be read closely. OK Times stories yesterday and today, but here is the line I found worth copying from the report:
    “Our ability to assess the effect of these departures on the decision-making process was in many cases undermined by the failure of important decision-makers to sufficiently explain and document the bases for their decisions in an administrative record. This failure constitutes a clear deviation from the principles of integrity used in this review and undermines the ability of the agency to counter the suggestion that lobbying on behalf of ReGen affected the decision.”
    I think you are right, Carl.
    Yet I find it troubling that integrity depends entirely on who does the appointing of top officials. No set of rules guarantees integrity, but the political lines of authority here make it too uncertain. More independence, tighter mission, seem in order.

  2. […] Safe & Effective?Since the appointment of Dr. Margaret Hamburg as FDA Commissioner FDA has made steady progress in modernizing the Agency. Will the 2010 elections undo that? Steve Grossman reported a few weeks ago in FDA Matters that “deficit hawks” could threaten future FDA funding. That funding provides consumer protection for 25% of the U.S. economy. Think back to the period before Dr. Hamburg’s appointment to the merry-go-round of ineffective FDA Commissioners and Acting Commissioners. The lack of effective leadership in an era of globalized food and drug industries is not the direction to be heading. Early entries into this blog were full of FDA follies. Now commentaries on GxP Perspectives are about the modernization of regulations for adverse event reporting. It has been quite a positive change. Here is an early post on Faulty Device Approvals. […]

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