© Oxford University Press 2006.
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Report Hits FDA to Revamp Safety Oversight
The Food and Drug Administration continues to feel pressure to revamp its safety surveillance systems after a critical federal review of postmarketing oversight failures.
A congressionally requested analysis from the U.S. Government Accountability Office found that the FDA lacked a consistent process for acting on postmarketing safety data and, in fact, restrained some results from being presented to decision makers. Agency critics recommend a multitude of fixes, including everything from minor repairs to a complete overhaul, but whether such changes will be made is unclear.
"Despite recent developments, the FDA remains an agency in denial when it comes to the problems addressed in this new report. In fact, many concerns about the agency's postmarket review of drugs are not new. GAO says they date back over 30 years," Republican Sen. Chuck Grassley of Ohio said in a briefing.
The GAO report cited several instances where the FDA's Office of New Drugs kept staff of the Office of Drug Safety from presenting safety concerns to the advisory committees that the agency relies on to review and make recommendations on drug approvals.
Those findings confirm that the Office of Drug Safety, which is responsible primarily for assessing safety data after a drug enters the market, is "underfunded, lacking independence, and lacking decision-making responsibility." The report also shows that the Office of New Drugs, which is responsible for approving and disapproving drugs, faces a persistent conflict of interest when overseeing those same drugs, said Grassley, who requested the report.
The GAO also found that there was often poor communication between the Office of Drug Safety and the Office of New Drugs.
"Despite the fact that ODS's epidemiologists have some defined responsibilities, there appears to be some confusion about the scope of their activities and a lack of understanding on the part of OND about their role and capabilities," the report states.
Aside from having a poorly defined role within the agency, the Office of Drug Safety has also suffered from a lack of consistent leadership. ODS has had eight different directors in the past 10 years, and four of those have been acting directors. A new director was named in October 2005, the first permanent director in 2 years.
"The Director of [the Center for Drug Evaluation and Research], as well as staff within and outside of ODS, told us that the lack of consistent leadership of ODS has had a negative effect on the work and morale of staff. One ODS staff member told us that since drug safety issues often take a fair amount of time to resolve, it is important to have consistency in leadership so that the leaders are knowledgeable of ongoing issues," according to the report.
The FDA welcomes the GAO report and is leading a comprehensive effort to transform how staff manage safety issues, according to an agency spokeswoman.
"Many significant reforms have already taken shape and are leading to improvements in how we and the public-health community identify, assess, manage, and communicate emerging drug safety information," she said.
Changes Needed
In response to the report, Grassley called on his Senate colleagues to act on legislation that would give the agency the authority to require companies to conduct postmarketing studies. The GAO also said that Congress should give the agency more power. Currently, FDA can only levy small fines or revoke drug approval to penalize companies that fail to complete postmarketing research commitments, but it has no other enforcement options.
Those recommendations, however, don't go far enough, said Brian L. Strom, M.D., M.P.H., professor of public health and preventive medicine at the University of Pennsylvania in Philadelphia.
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"The real problem isn't the FDA or the people within the FDA," he said. "The real problem is the structure that was set up by Congress."
The current system provides the agency with little incentive to find problems with drugs after they have entered the market. It also contains no motivation for companies to conduct postmarketing safety assessments, which can result only in marketing restrictions on their products.
"Both FDA and industry have been acting rationally and properly under a twisted system," Strom said. He pointed out that the response to recent problems in postmarket surveillance has not been to rectify the problem but instead to slow the approval process.
Strom recently proposed his own fix, called conditional approval, in an article published in the Journal of the American Medical Association. Conditional approval would allow drugs to come to market sooner, improve the availability of real-world surveillance, and create incentives for companies to produce safety data. Such a change would require congressional action.
It's not clear that the motivation for such a change exists. Grassley, who again recently criticized the FDA for keeping information posted on their Web site about a postmarketing study of the antibiotic Ketek (telithromycin), which the Office of Drug Safety has identified as fraudulent, has called for major changes but within the existing structure of the agency.
"The leadership of the Food and Drug Administration faces tough challenges. The first step is to acknowledge the problems and make a commitment to reform now rather than later," said Grassley.
There seems little hope that Congress will make substantial changes to the agency's structure or mandate, given that the only proposals currently on the table call for only modest reforms. Even Grassley's provisions, despite bipartisan support, were recently stripped from an agricultural appropriations package, leaving its future uncertain.
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