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A Victim of Their Own Devices
Guidant’s problems should lead the FDA to rethink how it collects postmarket safety data.

Peter J. Pitts
Medical Progress Today
December 8, 2005

Once again into the abyss of FDA reform. The issue at hand is the FDA’s continuing struggle with 21st century post-market surveillance—this time in the realm of medical technology. How can we make certain that crucial information on adverse events and mechanical problems is swiftly transmitted to the FDA and then acted on with equal alacrity? Or to be blunt, how can reform from within the FDA create a mindset that places post-approval information on par with pre-approval submissions among the medical technology community?

The subtext is the angst-inducing problems with Guidant defibrillators. Solid reporting by Barry Meier of the New York Times raises some troubling and important matters. The first, of course, is what did Guidant know, when did they know it, and why did they delay reporting important adverse events to the FDA? The second, more troubling question, isn't when the FDA knew—it's why didn't they act sooner? Or, to be more precise, how long did the report reside in a Centers for Devices and Radiological Health (CDRH) in-box before it was read and acted on?

The first set of questions raises the specter of disquieting corporate shenanigans. But the issue of CDRH timeliness is, in the broader scope of the public health, more important, more troubling and, believe it or not, easier to address and remediate. The "front end" of CDRH, the application, review, and judgment of medical devices, functions well enough. The "back end," the part that deals with post-market surveillance issues, not as well. Devices, like drugs, have risks as well as benefits, and when they fail, bad things can happen. In the Guidant case, people died.

The dedicated career staff at CDRH, under the respected leadership of Dan Schultz, work hard—but they (like the rest of FDA) are under-funded and under-staffed. Let me be clear. There is no excuse for delay—but human beings can only do so much. Minus an increase in funding (which doesn't seem to be in the cards any time soon) something else must be done, from a process perspective, to eradicate delays of potentially life-saving information. Even if Guidant had submitted its report on time (which it did not—for the first time—something else that's disquieting), it's likely the FDA would have taken the same amount of time to read it, digest the implications and issue the same public health advisory. And the FDA is not alone in the hot seat. Senator Charles E. Grassley, the chairman of the Senate Finance Committee, has notified Guidant that he is investigating whether the company had violated a 2003 agreement that required it to alert the government to product problems.

The question isn't commercial confidentiality. That's not even relevant. The issue is timeliness. And the answer is for the FDA to take a hard look at its existing processes and make them better. The New York Times, editorializing on its own report, recommends an interesting option—separate the wheat from the chaff. The agency should ask device companies to provide a separate "hot sheet" that directs the FDA's attention to the most crucial information—rather than burying it deep within the bowels of a more lengthy report. Drugs have risks and devices fail—that's the world in which we live. And it's all the more reason for device manufacturers to step up to the plate and be a more senior partner in protecting the public health. But corporate behavior is no excuse for an FDA process issue. A problem has been identified and a solution suggested. Now it's time for the dedicated public servants at the FDA to solve it—and fast, because regulatory delays have consequences, sometimes deadly ones, sometimes financial ones

Just ask Guidant. According to another story in the New York Times, as a result of Guidant's recent problems the company’s acquisition by Johnson & Johnson may be renegotiated at a lower price or even unravel. And on October 18th, Guidant shares fell 11 percent after Johnson & Johnson announced it was considering options related to its planned $25.4 billion acquisition of the heart device maker. Executives at J&J said they consider the regulatory issues involving Guidant to be serious and that J&J will closely monitor the situation. "In light of these matters and their impact, we are continuing to consider the alternatives under our merger agreement," said J&J CFO Robert J. Daretta. The rest, as they say, is (well, at least almost) history.

For the FDA and its stakeholders, it's always the right time for reform and it's always the right time for honesty and safety.

Peter J. Pitts is a former Associate Commissioner at the Food & Drug Administration and Senior Vice President for Global Health Affairs at Manning, Selvage & Lee.

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