Blog Topic

Why FDA Preemption should worry ordinary folks
Posted by: Melinda Derish
April 16, 2008

In response to the Supreme Court's recent decision in Riegel v. Medtronic, FDA preemption has been in the news a lot recently. It should stay there until people get the message loud and clear. This year the Court will hear Wyeth v. Levine, which may take preemption even farther than it has gone already, to the delight of drug and medical device companies.

This weekend's letter to the editor of the New York Times - "Drug Makers' Advantage" is right on target. In his letter, Henry Greenspan, faculty scholar at the University of Michigan, explains that FDA preemption makes as much sense as preemptive war - neither is connected to the way the real world works.

In the real world, drug and pharmaceutical companies already wield the clout of billion dollar industries.  In the real world, in the name of saving taxpayer money, drug companies pay the salaries of FDA scientists who are supposed to regulate them.  FDA preemption will have drastic effects on real folks who don't have that kind of clout, but most don't think about preemption very often, or at all!  And if they do, they may not understand how FDA preemption can hurt them.

The pharmaceutical and medical device industries have sought FDA preemption for years. Preemption for them means that whenever the FDA says a drug or a medical device can be marketed in the United States, the patient's right to sue in state court is preempted. That's right, patients who are negligently harmed by drugs or medical devices sold in the U.S. could not sue for their injuries. The same would be true whether the drug or device was negligently designed, manufactured, tested, or marketed.

FDA preemption might not be quite so scary if the FDA had a good track record for keeping dangerous drugs and devices off the U.S. market. But it's pretty clear by now that the FDA's record for protecting patients from dangerous drugs and medical devices (e.g., Vioxx and Medtronic defibrillators) is seriously flawed.

Congress knows the FDA isn't getting the job done.  For example, Senator Charles Grassley of Iowa, who has conducted oversight of the FDA's reviews for drugs and medical devices, believes that the FDA's relationship with the drug industry is "too cozy." In September 2007 he wrote: "Congress needs to do everything it can...to make the FDA more independent, rigorous and responsive in its work. Unfortunately, the case for reform gets stronger all the time, as new questions continue to emerge about FDA actions and inaction."

The medical profession also tracks the FDA's poor performance. For example, the Institute of Medicine ("IOM") published a 2006 report, The Future of Drug Safety, that identified several FDA deficiencies and made recommendations to fix them. The FDA has not followed those recommendations. As one advisor to the FDA and consultant to the IOM explains, the FDA "is in need of monumental change...." (Sheila Weiss Smith, Sidelining Safety- the FDA's Inadequate Response to the IOM, New England Journal of Medicine, September 6, 2007, Volume 357, pp. 960-963.)

Since 1992, the FDA has relied heavily on the pharmaceutical industry to pay the salaries of the FDA scientists who review new drug applications.  Prominent doctors who have worked at the FDA worry that because of this, the agency has a growing sense of accountablity to the industry it regulates instead of to the people it is supposed to protect.  (Dr. Jerry Avorn, Paying for Drug Approvals- Who's Using Whom?, New England Journal of Medicine, April 26, 2007, Volume 356, pp. 1697-1700.)  To those who argue that having the industry pay its own regulatory agency helps save the taxpayers' money, the obvious response might be that you get what you pay for. 

It's pretty interesting that the FDA has reversed its own position on whether preemption is a good idea. During the Clinton administration, the FDA argued that the agency's approval of medical devices should not preempt state lawsuits. Under the Bush administration, the FDA has reversed its position. Does anyone think the Bush administration could be pro-corporation, anti-ordinary folks?

Many people are surprised to learn that once the FDA lets drugs and medical devices onto the U.S. market, it has no active surveillance system to monitor their safety.  Instead, it waits passively for adverse event reports or complaints by doctors or hospitals to come to the manufacturer, who is responsible for investigating.  After the manufacturer conducts its own investigation into the complaints, it makes a report to the FDA. (Again, you get what you pay for.)  As former FDA commissioner Dr. Mark McClellan explains: "One key reason drugs may be used for years by millions of patients before risks become evident is that the United States has no active drug surveillance system."  (Mark McClellan, Drug Safety Reform at the FDA- Pendulum Swing or Sytematic Improvement?, New England Journal of Medicine, April 26, 2007, Volume 356, pp.1700-1704.)

It is during the time when active drug surveillance should be happening that some patients are harmed, and some of them (or their families) bring a lawsuit in their state's court.  Frequently, that is when the public learns for the first time about why a drug or device on the U.S. market is dangerous.  And it is in response to lawsuits, and the information they uncover, that the FDA often acts for the first time to recall a drug or device.

As Mr. Greenspan points out: "It is not often that doctors defend trial lawyers." But this should be one of those times. Because trial attorneys who devote their careers to representing negligently injured patients and doctors who devote their careers to caring for patients should be fighting together to fight FDA preemption. The public should call on their legislators to do so. And this is the year to do it, before it's too late.

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