Congress Expands FDA's Oversight On Drug Safety

[JohnMack]

Source: Wall Street Journal

By SARAH RUBENSTEIN, HEATHER WON TESORIERO and ANNA WILDE MATHEWS
September 21, 2007; Page A12

Legislation expanding the Food and Drug Administration's drug-safety oversight won final congressional approval, but its impact on the pharmaceutical industry will depend largely on how the agency opts to use its new powers.

The bill, which the Senate passed yesterday following House approval Wednesday, increases the fees that drug makers pay the FDA to review their drugs and allots a portion of the money for the agency to monitor the safety of drugs after they go on the market. It also solidifies the agency's authority to mandate changes to drug labels, require additional safety studies and limit the distribution of medications when safety concerns arise -- powers that have existed informally but haven't always been clearly delineated.

Amid safety concerns about Merck & Co.'s Vioxx, which was withdrawn from the market in 2004, as well as other painkillers, antidepressants and diabetes medications, lawmakers and consumer groups have accused the FDA of allowing drug makers to drag their feet before making label changes or taking other precautionary steps.

With its expanded clout, an FDA leadership motivated to flex its muscles could lean on the bill's provisions to require label changes and other measures -- bolstered by civil monetary penalties for noncompliance -- without having to secure cooperation through give-and-take with the industry.

But the agency could also fall back on approaches it has relied on in the past, engaging in discussions with companies about safety concerns and looking for mutually acceptable ways to resolve them. The FDA already had the ability to mobilize public opinion by trumpeting its concerns in news releases or to demand that drugs be pulled from the market -- tools the drug companies say already gave the agency significant leverage.

For the most part, drug companies say they welcome the changes, hoping that with more money and power, the FDA will resolve safety worries more quickly -- and with measured approaches that don't scare the public or entail calling for withdrawal of drugs from the market.

The idea is to have "more-thoughtful discussions of these matters" than have taken place during controversies such as the recent one over the safety of diabetes drug Avandia, said Timothy R. Franson, vice president of global regulatory affairs for Eli Lilly & Co.

One negative for the industry may be how the bill affects drug makers' legal liability for FDA-approved drugs.

Last year the industry got an assist from a Bush administration change to FDA regulations, saying FDA-approved drug labels pre-empt state laws. Drug makers have since seized on this policy change as part of their defense in product-liability suits, arguing that an agency-approved warning absolves them of any subsequent liability.

The new legislation could limit that protection at a time when the industry is dogged by product-liability litigation. Merck faces some 27,000 lawsuits over Vioxx alone.

Some experts say the new shift of greater power to the FDA doesn't resolve such pre-emption issues, since the agency's bigger role also implies additional responsibility for assuring safety. "The plaintiffs are trying to have it both ways, having the FDA have more power, but claiming at the same time that that doesn't have greater pre-emptive effect," said Daniel Troy, a former FDA chief counsel who now represents drug companies in private practice.

But the matter may be decided drug by drug. Those that undergo greater postmarketing FDA scrutiny, for example, might be more likely to be granted pre-emption.

Write to Sarah Rubenstein at sarah.rubenstein@wsj.com1, Heather Won Tesoriero at heather.tesoriero@wsj.com and Anna Wilde Mathews at anna.mathews@wsj.com