FDA critics slam plan for safety reform

from news@nature

17 February 2005

Emma Marris

Calls grow for independent supervision of US drug regulation.

The US Food and Drug Administration is under fire again. © FDA

In an effort to regain the public's trust after a series of scandals, the United States' drug regulatory agency has announced plans for a new safety board. But public interest groups and some lawmakers are deeply sceptical about how much impact the group will have.

Mike Leavitt, the new head of the US Department of Health and Human Services, this week announced reforms at one of his agencies, the beleaguered Food and Drug Administration (FDA). The agency has been criticized for zealously defending their initial safety decisions on drugs, such as Vioxx, that turned out to be dangerous.

Leavitt plans to create a Drug Safety Oversight Board, which will be appointed by the FDA commissioner and will make recommendations to the Center for Drug Evaluation and Research (CDER). The board will consist of CDER employees and other government officials who will make recommendations about how and when to inform the public about drug safety. "It is primarily charged with making decisions about risk management or communication issues," says an FDA spokesman.

The FDA's critics, who have been calling for a drug-safety office detached from the CDER, or even moved outside of the FDA altogether, are not appeased. "This is smoke and mirrors and musical chairs," says Vera Sharav, president of the New York-based Alliance for Human Research Protection. "They will be using the very same officials that are the problem."

Senators move in

Larger changes to how drugs are declared safe and how they are monitored after sale will wait until the agency receives the results of an audit by the Institute of Medicine, a branch of the National Academies, based in Washington. The FDA commissioned the study in November 2004, but it has yet to begin and could take more than a year.

Meanwhile, the Republican senator for Iowa, Chuck Grassley, and the Democrat senators of Connecticut, Chris Dodd, and Massachusetts, Edward Kennedy, are planning legislation that will radically change the structure of the FDA.

Dodd and Kennedy issued statements on 15 February saying that the board was a step in the right direction, but did not go far enough. They called for more money to tackle drug-safety supervision.

Agency in the hot seat

The senators' announcement came during a busy week for the FDA as it faces safety hearings and a decision on the commissioner's job.

Hearings on the allegations that the FDA suppressed results about the safety of a class of painkillers called COX-2 inhibitors are running from 16 to 18 February.

One of the drugs is rofecoxib, sold under the name Vioxx by pharmaceutical giant Merck. Vioxx was yanked from the market after dramatic testimony by whistle-blower David Graham, who claimed that CDER officials had tried to prevent him from disseminating information about the danger of the drug (see "Suppressed study raises spectre of flawed drug regulation in US").

And on 14 February, President George W. Bush formally nominated the acting commissioner of the FDA, Lester Crawford, for the permanent job.

"Crawford hasn't been willing to stand up to the political pressure that the agency has been under," says Amy Allina, programme director at the Washington-based National Women's Health Network. "We need a strong commissioner at the FDA, one who is really committed to making evidence-based decisions."