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The right prescription for drug safety

Marie Gryphon, Paul Howard
DC Examiner
December 4, 2008

Last month, the Supreme Court heard oral arguments for the most controversial and important business case on its winter docket, Wyeth v. Levine. Largely overlooked during the election, the case hinges on whether the FDA's decision on what warnings should or shouldn't be required on a prescription drug label "preempts" lawsuits in state courts alleging that drug companies failed to warn consumers of possible side effects. A ruling in favor of FDA preemption would be a change for the better from the "sue anywhere, for anything" status quo. Companies that provide the FDA as Wyeth did - with truthful information about drug risks, which are then incorporated into the FDA-approved label, would be protected from "failure to warn" lawsuits. Patients could still sue companies for withholding information from the FDA or for side-effects that weren't listed on a drug's label.

If Wyeth loses its appeal, drug companies would have a powerful incentive to flood the agency with alternative label warnings in hopes of finding the "magic words" that might protect them from litigation. They would also issue more contraindications on drug labels, effectively prohibiting uses that benefitted the vast majority of patients.

Opponents of preemption make three basic arguments: First, the FDA doesn't have the resources or powers to adequately monitor drug safety alone; next, that drug withdrawals are evidence of the agency's failure to weed out "unsafe" drugs; and, finally, that lawsuits force manufacturers to make safer products since they know they can be sued when something goes wrong.

The FDA is famously imperfect. But it does not follow that interference from tort lawyers will do more good than harm when it comes to drug safety and labeling practices. Plaintiffs' lawyers receive contingency fees of 33% or more. This is a powerful incentive to press any colorable claim, even those involving drugs that unquestionably do more good than harm.

It also produces powerful incentives to drive up aggregate attorney's fees by lumping thousands of fraudulent or minor injuries in with a few serious ones. Average award per claim then falls hurting the claimants who most deserve compensation.

This is exactly what happened in the multibillion dollar Fen-Phen litigation, which American Lawyer says "will long be remembered as a mass tort debacle." In 2004, cardiologists at Duke University reviewed hundreds of echocardiograph records alleging injuries and approved for payment; 70 percent, they concluded, should never have been approved.

Every time a rare but serious drug safety problem is discovered after FDA approval, as with Vioxx, lawyers claim that the agency has failed to protect us from "unsafe" drugs and launch multibillion dollar lawsuits. The reality is much more complex.

Before the FDA approves a drug for marketing, most will have been tested in relatively small clinical trials with several thousand patients; after approval, some rare side effects may not be discovered until after a drug is taken by millions. But that doesn't mean that drug safety testing failed, or that companies hid data. Human biology is mind-bogglingly complex, and side effects are difficult to predict.

While additional testing might uncover more rare side effects, it would also slow access to new therapies. We tolerate rare side-effects and occasional drug withdrawals because the benefits of the vast majority of FDA-approved medicines outweigh their risks.

Finally, the argument that preemption would weaken drug safety is not supported by real world evidence. After litigation nearly bankrupted the vaccine industry in the early 1980s, Congress created the National Vaccine Injury Compensation Program in 1986, which preempts most vaccine lawsuits.

The program offers generous compensation to injured patients based on a list of vaccine-related injuries developed by scientific experts. While vaccine litigation has declined sharply, vaccines today are safer than they ever have been before, thanks to advances in science and manufacturing.

Managing and communicating complex drug safety risks is best left to the FDA, not the courts, because the agency has the scientific expertise to balance the harm of over warning millions of patients against the risk of serious side effects for a few. Preemption is, ultimately, the best prescription for drug safety.

Paul Howard, Ph.D. is a senior fellow and director of the Manhattan Institute's Center for Medical Progress. Marie Gryphon, JD, is a senior fellow at the Institute's Center for Legal Policy.

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