F.D.A. Widens Safety Reviews on New Drugs

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BlankJanuary 31, 2007

F.D.A. Widens Safety Reviews on New Drugs

By GARDINER HARRIS

The Food and Drug Administration announced changes yesterday that were intended

to ensure that marketed drugs are as safe as advertised, including the first

effort to do a comprehensive assessment of the safety of drugs 18 months after

introduction.

The agency also announced the creation of an advisory panel to improve the way

it announces safety worries and a collaboration with the Veterans Health

Administration to track how real patients fare after taking drugs.

The F.D.A. plan is the latest effort to fix the agency after a series of

missteps. In September 2004, Merck withdrew its arthritis drug, Vioxx, after a

study showed that it doubled the risks of heart attack. About the same time, the

agency announced that antidepressants cause some teenagers to think more about

suicide.

In both cases, the agency took years to acknowledge risks to millions of

patients that had been apparent to some researchers.

“We don’t see this as the only answer,” said Dr. C. von Eschenbach, the

F.D.A. commissioner, at a news conference in Washington announcing the

initiatives. “It’s merely a step as we continue a process of improvement that

will be ongoing.”

Senator J. Dodd, Democrat of Connecticut, said in a written

statement that far greater changes were needed at the agency. Mr. Dodd promised

to introduce two bills today that would reorganize the F.D.A. and require drug

makers to disclose the results of all clinical trials involving humans. The

bills’ co-author, Senator E. Grassley, Republican of Iowa, has called

the agency far too “cozy” with drug makers.

In many cases, the date that the agency will begin the efforts announced

yesterday is uncertain. For instance, Dr. Galson, director of the

agency’s drug center, said at the news conference that the pilot program to

assess systematically a drug’s safety 18 months after its introduction would

probably take about a year to put into place — with the assessment due 18 months

after that.

“We’re just organizing that process to get started,” Dr. Galson said.

In a scathing assessment released in September, the Institute of Medicine

concluded that the F.D.A. was rife with internal squabbles and hobbled by

underfinancing, poor management and outdated regulations. The institute, the

most important medical advisory organization in the country, suggested that the

agency undergo 25 major changes, many of which would require Congressional

authorization.

Alta Charo, a professor of law and bioethics at the University of Wisconsin and

one of the authors of the Institute of Medicine’s report, described the F.D.A.

announcement yesterday as “a good set of first steps towards improving the

safety of the drug supply in the United States.”

Professor Charo said she was “disappointed” that the agency had failed to adopt

some of the institute’s bolder recommendations, including one suggesting that

the agency give greater authority to officials who assess the safety of drugs

after they go on the market.

“We viewed that as critical,” she said.

Alan Goldhammer, deputy vice president for regulatory affairs for the

Pharmaceutical and Research Manufacturers of America, praised the F.D.A.’s

announcement as a “very thoughtful and comprehensive response” to the Institute

of Medicine’s report.

“The agency has made substantive and significant progress in improving and

enhancing the drug safety system in the U.S.” said Mr. Goldhammer, whose

organization represents drug makers.

Still, the plan does little to address a problem that nearly all agree underlies

many of its woes: a chronic shortage of government money. As Dr. von Eschenbach

noted at the news conference, the agency has regulatory authority over about a

quarter of the American economy. After the Sept. 11 attacks, the agency was

asked to increase its efforts to prevent bioterrorism. Despite having greater

responsibilities, its budget has remained relatively flat for years.

There are now thousands of drugs in routine use. Figuring out which of these

medicines may have undiscovered side effects will take a lot of money. The

agency gets about $400 million of its $1.9 billion budget from fees assessed on

drug makers. Under a formula negotiated with the drug industry, this money comes

with strings attached. One restriction was that the F.D.A. could use little of

the money to track the safety of approved drugs.

That deal between the F.D.A. and drug makers expires this year, and the drug

companies have agreed to allow more of their money to be used for postmarket

safety assessments. Whether those fees are enough, whether there should be any

strings attached to them and whether that money should be coming from drug

makers at all has become the subject of fierce debate.

“Drug makers clearly get their money’s worth with all this money,” said Dr.

Sidney Wolfe, director of Public Citizen’s health research group. Dr. Wolfe and

other consumer advocates say that the F.D.A.’s dependence on drug industry fees

has softened its oversight.

Dr. Gottlieb, who last week left his job as the F.D.A. deputy commissioner

to return to the American Enterprise Institute, a free-market research group,

said the real debate unfolding around the agency is between those who believe

that it needs more money and tools to assess drug risks, and those who believe

that the agency should begin regulating the practice of medicine.

“I think we need to give the agency the resources it needs to get information

about drug risks quickly,” Dr. Gottlieb said. “But we don’t need the government

telling doctors and patients what to do.”

The F.D.A. plan promises to return the agency to its scientific roots. It once

had robust laboratories that conducted original studies to assess drug risks on

its own. Those laboratories were largely eliminated in the past decade to apply

more money to the drug-approval process and the support of a bare-bones computer

program to track side effects of drugs.

But in the past two years, the agency has begun an effort to improve the science

of drug safety, making itself an active participant in scientific endeavors once

left exclusively to drug makers and basic scientists.

The efforts announced yesterday included the creation of a database of genetic

codes associated with bad drug outcomes, the development of a computer model to

identify patients who are most likely to suffer liver injury, and the design of

screening tests that would identify patients most at risk of general drug

problems.

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