Panel: FDA needs more power, funds

WASHINGTON -- The Food and Drug Administration lacks clear regulatory authority and is chronically underfunded, shortcomings hindering its ability to evaluate the safety of drugs used by millions of Americans, according to outside scientists the agency asked to critique its performance.

The assessment from the independent panel comes nearly two years after the painkiller Vioxx was pulled from the market, a move that prompted thousands of liability lawsuits and a series of congressional hearings on the safety of drugs approved by the FDA.

The Institute of Medicine committee, in a $1.8 million report released yesterday , suggested 25 sweeping changes to bolster drug safety. One of the 15-member panel's strongest recommendations is a two-year moratorium on advertising for new drugs. The scientists also said new products should carry a label indicating that they may be less safe than drugs that have established sales histories.

If Congress and the drug industry can't fully fund improvements to the FDA, the panel said, more than $100 million annually could be raised through a tax of 10 cents per prescription. In addition, the panel said the FDA should be able to require such actions as quick changes to drug labels -- something it could not do with Vioxx -- the report said.

Since Merck & Co. voluntarily withdrew Vioxx, the FDA said it has aggressively improved how it uncovers drug risks and informs the public about potential dangers. Dr. Andrew von Eschenbach , acting FDA commissioner , said the agency will detail more changes after studying the report and receiving comment.

Even if the FDA moved to put a moratorium on advertising, manufacturers could challenge the decision, said Alta Charo , a University of Wisconsin law professor who served on the panel. ``Offering discretion does not mean offering dictatorial power," Charo said.

But a ban on advertising for FDA-approved drugs is unlikely to be upheld by the Supreme Court, said Daniel Troy , a former FDA chief counsel who now represents drug firms. Troy said the court ``has invalidated restrictions on ads for tobacco, gambling, alcohol, and compounded drugs." And its stance toward commercial free speech has become even more pronounced since Justices Samuel Alito and John Roberts joined the court, he said.

Another controversial suggestion by the Institute of Medicine panel would lift restrictions on how the FDA spends hundreds of millions in fees it receives each year from the drug industry. In some years, user fees account for 50 percent of the FDA's budget to review new drugs. Congress needs to correct a ``troubling resource imbalance" that insufficiently funds monitoring of drugs already on the market, according to report. Congress should do so through appropriations, the report said, or free up more money for drug safety by lifting restrictions on how user fees can be spent. Alternatively, it said, the 10-cent tax on prescription drugs could be implemented.

A Pharmaceutical Research and Manufacturers of America spokesman said the group has not taken a position on whether user-fee money intended to speed the drug approval process should be used to monitor the safety of treatments on the market.

On Monday, a coalition that includes drug industry representatives will begin pushing for more congressional funding for the FDA. The FDA's more vocal critics in Congress, meanwhile, are prodding President Bush to add his weight to the FDA reform effort.

``Vioxx was like a dead canary in a coal mine, a warning that worse may yet come," said Senator Charles Grassley , Senate Finance committee chairman. Yesterday Grassley called on the Bush administration to support Congress as it pushes for FDA reform. ``There's no question left that we need to strengthen post-market surveillance in order to improve drug safety and save lives," he said.

The heightened focus on drug risks during the pre-approval stage and the use of industry user fees for drug safety purposes are similar to the aim of FDA reform legislation co-authored by Senators Edward M. Kennedy , Democrat of Massachusetts , and Michael Enzi , Republican of Wyoming .

Diedtra Henderson can be reached at dhenderson@globe.com.