For the Food and Drug Administration, the agency charged with ensuring drug safety, 2007 brought a slew of charges undermining its credibility. The most widely reported involved a study by Cleveland Clinic cardiologist Steven Nissen showing that the diabetes drug Avandia, FDA-approved in 1999, raised the risk of heart attack by 30 to 40 percent. The agency was also called to testify before Congress about its inaction regarding side effects of the antibiotic Ketek and a widely used class of anemia drugs. In addition, a study published in the Archives of Internal Medicine in September found that reports of serious side effects and deaths caused by FDA-approved medicines nearly tripled between 1998 and 2005, to about 90,000.
The accumulation of evidence apparently forced a reckoning in Congress and the White House. On September 27, President Bush signed into law an amendment giving the agency unprecedented new powers to conduct and demand safety studies on approved drugs, police drug advertisements, and require companies to register data from their clinical trials in a publicly available database. The new law also boosts the agency’s budget, an increase approved in time to avert the layoffs of some 2,000 FDA employees, including many researchers.
“This has been a tough year,” acknowledges Janet Woodcock, deputy commissioner of the FDA and acting director of the agency’s Center for Drug Evaluation and Research. “[But] I do think this is an inflection point about the communication on drug safety. We have the opportunity to set up new systems.”
Bruce Psaty, a drug safety expert at the University of Washington, says the agency had been too sluggish in responding to reported problems about Avandia. “On occasion, there will be problems [with drugs]. That’s normal,” says Psaty. “The FDA should not be judged to have made an error when a drug is found to be unsafe. But it’s an issue of timeliness. With Avandia, they did not seem to me to do well because they had this info for nearly a year.” The European Medicines Agency, in contrast, added a warning to the label in 2006.
Woodcock says the agency was evaluating the information when Nissen published his analysis in the New England Journal of Medicine last May. “We weren’t sitting still,” she says. “There are times when we are also going to be criticized for putting information out too early.”
Among the new law’s mandates is the creation of a clinical trial registry as well as an active surveillance system—rather than the current network of anecdotal reports from doctors and companies—that would spot problems with approved drugs faster. The law also calls for a new database that would scan hospital and insurance records for trends in side effects of certain drugs and include data from 25 million patients by 2010.
When the agency spots problems, it now has the authority to require companies to conduct follow-up studies on approved drugs and to make changes to the drug labels. The FDA also has greater powers to ensure that drug advertisements, including those that target consumers directly, present safety risks clearly—and not merely in quick, tacked-on lists, like those that now follow most television ads for drugs.
Many of the law’s provisions were outlined in an Institute of Medicine (IOM) report, The Future of Drug Safety, released in 2006. Fulfilling one of that report’s recommendations, in September the agency launched a drug-safety newsletter to update doctors. The FDA also announced in June that a new committee of ethicists, journalists, and marketing specialists would advise the agency on communicating drug risks to the public. Further, in an attempt to make the agency more credible and independent, the law aims to limit the number of scientists with financial conflicts of interest who can serve on FDA advisory panels.
The law does not, however, tackle one of the report’s principal recommendations: an overhaul of the user-fee system. Under this system, drug and device manufacturers pay the FDA user fees totaling more than $300 million—to be increased under the new law to at least $400 million—each year in exchange for speedier review of their applications. The IOM report recommended that the companies have no say in how that money is spent and that the funds be directed to improving drug safety and other programs at the FDA. Critics note that by maintaining the status quo, the law keeps FDA officials’ salaries dependent on the very industry they regulate.
Merrill Goozner, director of the Integrity in Science project at the Center for Science in the Public Interest, in Washington, D.C., contends there should be a publicly funded drug safety arm that functions completely independently within the FDA and has veto power over new drug approvals. In the meantime, he says, “This is progress, there’s no doubt about it.”
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