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Commentary By Paul Howard

Pharmaceutical Litigation For All, and Safety For None

Governance Civil Justice

Congress is considering renewing the federal Prescription Drug User Fee Act, but plaintiff’s lawyers and their House allies are trying to hijack the legislation and use it to siphon billions of dollars from the pharmaceutical industry into their own pockets.

First passed in 1992 and signed into law by former President Bush, the user fee act is a critical piece of legislation that helps fund the Food and Drug Administration’s review of new drugs through fees the FDA uses to hire additional staff. Renewed every five years, the act has been widely praised for helping the FDA speed up its review of new drug applications.

The Senate recently passed its version of the legislation: a bipartisan compromise that gives the FDA increased funding as well as new powers to monitor drug safety. However, plaintiff’s lawyers are trying to insert a dangerous provision into the House bill still being drafted that would open the industry to a flood of new litigation. Language in the draft would allow them to sue drug companies in state courts — even if they complied with all FDA labeling and reporting requirements — and would replace a single FDA-approved label with 50 different, incoherent state standards for disclosing potential side effects.

Rep. Michael Burgess, R-Texas, told the National Journal that the new language, if approved, “will open up the state courts for a situation that might be deemed ‘litigation for all.’ ”

It will also slow medical innovation and cost lives. All drugs have benefits and risks that have to be weighed carefully by patients and their doctors. Having one agency — the FDA — use sound science to weigh those risks and benefits and communicate them to the public ensures that companies know what standards they need to adhere to so doctors can find the best treatments for their patients.

Allowing lay juries in highly complex, emotional cases to second-guess FDA-required labels would dilute the science of drug safety and drive manufacturers to “data dump” endless warnings on labels — making them nearly useless to physicians but giving companies (some) protection from lawsuits.

Litigation also drains funding from the research and development of new medicines. Merck’s liability in Vioxx litigation could exceed $50 billion — more than enough to bankrupt the company and nearly twice the budget of the National Institutes of Health. Wyeth has set aside $21 billion to pay claims related to its diet drug Fen-Phen — about four times what the National Cancer Institute spends on research every year.

Expanding tort liability for the industry won’t make anyone safer. Pharmaceutical companies already spend, on average, about $1 billion and a decade of research to bring a single new medicine to market. Much of that expense is used to weed out unsafe drugs in lab testing and clinical trials. Still, there is often no way to predict rare side effects before medicines are used in hundreds of thousands — or even millions — of patients in the real world.

Making drugs safer takes better science, not more lawsuits. For instance, the Critical Path Institute in Arizona is working with the industry and the FDA to validate safety biomarkers for carcinogenicity, and vascular, liver and kidney toxicity that can help improve drug safety testing. The Senate version of the user fee bill also gives the FDA the ability to tap into databases held by public and private insurers to help identify rare side effects that might take years to identify using clinical trials.

Today, drug companies are damned if they do and damned if they don’t. When new side effects from drugs are uncovered, they will be sued no matter how responsible and forthcoming they have been with the public and the FDA. Writing about Vioxx litigation in The Washington Post, columnist Sebastian Mallaby says “the U.S. tort system creates an enclave of idiotic whimsy in the heart of the most open society in the world.”

Rather than expand liability, Congress should offer companies that agree to conduct post-market studies of their drugs “safe harbor” from punitive damages. This would give them a powerful incentive to update studies of their medicines long after they come onto the market.

The alternative is to allow everyone to sue for everything — and make us all less safe.

This piece originally appeared in

This piece originally appeared in