Proposals may change way drugs are regulated

The Baltimore Sun

WASHINGTON -- Since Vioxx was withdrawn from the market in 2004, drug companies, lawmakers and regulators have unveiled one initiative after another to make prescription medicines safer. But they haven't radically altered the way the government handles new drugs.

Now, the expiration of a key drug safety law is driving a flurry of activity that could lead to major changes.

Last week alone, lawmakers introduced two plans and federal drug regulators proposed a third. That's on top of an earlier proposal by the regulators. The House Energy and Commerce oversight subcommittee will hold a hearing on the issue Tuesday.

"You have an odd configuration of the stars that may lend itself to resolution this year," said Sheila P. Burke, who chaired a blue-ribbon panel that studied the issue for the Food and Drug Administration. Burke said it's unusual, and therefore promising, that so many people from all sides are proposing changes.

One reason for the frenzy: Democrats, who get less financial support from the pharmaceutical industry than Republicans, now control Congress.

Under a law that expires this year, manufacturers pay fees to the Food and Drug Administration to review the safety and effectiveness of new drugs.

Without the money, approval of new medicines would grind to a halt. So legislators see the renewal of user fees as an opportunity to consider other drug safety reforms.

"Congress will act on FDA-related legislation this year, and meaningful structural reforms to the agency need to be a part of what Congress does with regard to drug safety," said Sen. Charles E. Grassley, an Iowa Republican and outspoken FDA critic who offered one reform plan.

The House Energy and Commerce Health subcommittee expects to consider drug safety in its deliberations over renewing user fees, said a spokesman for the chairman, Democrat Frank Pallone Jr. of New Jersey. The Senate Health committee says it will do the same.

FDA officials kicked off the recent spate of proposals last month with one that would increase user fees to pay for monitoring the safety of drugs after they've gone on sale. They also recommended new fees to cover the cost of reviewing direct-to-consumer television advertisements. Critics say those ads encourage people to buy drugs they don't need.

"The proposed recommendations would support significant improvements in FDA's ability to monitor and respond to emerging drug safety issues," Health and Human Services Secretary Michael O. Leavitt said in a statement.

Drug companies say safety has always been a top priority, and the general record of prescription medicines has been good. The manufacturers, who worked with FDA officials on the proposal to renew user fees, argue that it does address drug safety concerns.

"What FDA needs is not new authority," said Scott Lassman, senior assistant general counsel to the Pharmaceutical Research and Manufacturers of America, the leading industry group. "What it needs is more resources and a more modernized approach, and that's what [the user fee proposal] would do."

Last week FDA officials announced new drug safety measures, including a pilot program to monitor the side effects of newly approved drugs, a newsletter about the medicines and a program to mine the Veterans Administration and other large medical databases to detect dangerous side effects earlier.

FDA Commissioner Andrew C. von Eschenbach called these proposals significant, but critics said they were really designed to preempt more radical moves by Congress.

"Most of what is in here is the FDA saying, 'We're going to do what we've been doing, but we're going to do it better,'" said Amy Allina, program director of the National Women's Health Network.

Addressing drug safety problems, Allina said, "requires something bigger."

The safety of drugs after they've been approved emerged as a public concern in 2004 with reports that the painkiller Vioxx increased consumers' risk of heart attack and stroke.

The drug was eventually withdrawn from the market, and fears about the system intensified with reports of conflicts of interest among university scientists who assess new medicines for drugmakers and advise the FDA.

Critics also assailed the pernicious effects of drug advertising and referred to additional problems with other pharmaceuticals, as well as medical devices.

A report by the Institute of Medicine last fall called for major changes, including giving the FDA authority to change labels or even recall drugs when it identifies serious side effects.

Burke, who chaired the panel that wrote the report, commended the FDA for proposing changes but said it didn't go far enough. The agency needs to involve its safety staff in reviews of on-the-market drugs much earlier than it does now, Burke said, and Congress must give the FDA more authority and money to do the job.

In his budget proposal for the coming fiscal year, President Bush added $11 million for drug safety, but Burke said that wasn't enough,"given the importance of the work that must be done and the inadequacy of funds at the agency."

A coalition of drug companies, liberal interest groups and former policymakers is urging Congress to raise FDA funding far more - by $40 million a year for five years.

"If you're going to be serious about drug safety, you've got to spend the money. You can't do this on the cheap," said William K. Hubbard, a former FDA associate commissioner who is helping the coalition.

Grassley and Democratic Sen. Christopher J. Dodd of Connecticut are sponsoring legislation that would create a new, independent office at the FDA to monitor the safety of drugs once they go on sale.

Experts say new drugs can cause the most harm because their health effects have only been tested in clinical trials, not in widespread use by thousands or even millions of consumers.

Meanwhile, the leaders of the Senate Health committee - Democrat Edward M. Kennedy of Massachusetts and Republican Michael B. Enzi of Wyoming - have fashioned their own proposal. It would require regulators and companies to develop plans for monitoring each new drug for side effects during its first three years of sales.

"We need a more effective system to identify and assess the serious risks of drugs, inform health care providers and patients about such risks, and manage or mitigate these risks as soon as they are detected," Kennedy said in a statement.

Rep. Henry A. Waxman, a California Democrat, will be introducing a companion bill in the House soon.

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