FDA says changes will boost drug safety

Critics contend steps don’t go far enough

By Gardiner Harris
NEW YORK TIMES NEWS SERVICE

January 31, 2007

The Food and Drug Administration announced changes yesterday that were intended to ensure 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 that it announces safety worries and a collaboration with the Veterans Health Administration to track how patients fare after taking drugs.

The FDA 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. At about the same time, the FDA announced that antidepressants cause some teens to think more about suicide.

In both cases, the FDA 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,” FDA Commissioner Dr. Andrew C. von Eschenbach said at a news conference announcing the initiatives. “It’s merely a step as we continue a process of improvement that will be ongoing.”

Sen. Christopher Dodd, D-Conn., said in a written statement that far greater changes are needed at the FDA. Dodd promised to introduce two bills today that would restructure the FDA and require drug makers to disclose the results of all clinical trials involving humans. The bills have been co-authored by Sen. Charles Grassley, R-Iowa, who has called the FDA far too “cozy” with drug makers.

In many cases, the date that the FDA will undertake the efforts it announced yesterday is uncertain. For instance, Dr. Steven Galson, director of the agency’s drug center, said at the news conference that the pilot program to systematically assess a drug’s safety 18 months after its introduction will 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,” Galson said.

In a scathing assessment released in September, the Institute of Medicine concluded that the FDA was rife with internal squabbles and hobbled by underfinancing, poor management and outdated regulations.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 FDA 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 FDA announcement as “a good set of first steps towards improving the safety of the drug supply in the United States.”

She said that 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 FDA’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,” said Goldhammer, whose organization represents drug makers.

Still, the FDA plan does little to address a problem that nearly all agree underlies many of its woes: a chronic shortage of government money. As Von Eschenbach noted, the agency has regulatory authority over about a quarter of the U.S. economy. After the Sept. 11, 2001, terrorist attacks, the agency was asked to beef up 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 agency could use very little of this money to track the safety of already-approved drugs.

That deal between the FDA and drug makers expires this year, and drug makers have already agreed to allow more of their money to be used for these post-market safety assessments. Whether those fees are enough, whether there should be strings attached to them, and whether that money should be coming from drug makers has become the subject of fierce debate.

“Drug makers clearly get their money’s worth,” said Dr. Sidney Wolfe, director of Public Citizen’s health research group. Wolfe and other consumer advocates say that the FDA’s dependence on drug industry fees has softened its oversight of drug makers.

Dr. Scott Gottlieb, who last week left his job as deputy commissioner of the FDA to return to the American Enterprise Institute, a free-market think tank, said that the real debate unfolding around FDA is between those who believe that the agency 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,” Gottlieb said. “But we don’t need the government telling doctors and patients what to do.”

The FDA plan promises to return the agency to its scientific roots. The FDA once had robust labs that undertook original studies to assess drug risks on its own. Those labs were largely eliminated over the past decade to plough more funds into the drug approval process and the support of a bare-bones computer program to track drug side effects.

But over the past two years, the agency has begun an aggressive effort to improve the science of drug safety, making itself a participant in scientific endeavors once left exclusively to drug makers and basic scientists.

Among these efforts announced yesterday was 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.