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WASHINGTON, D.C.—Long-standing concerns over the U.S. Food and Drug Administration's (FDA) oversight of post-market drug safety continue to plague the regulatory agency, three years after the investigative arm of Congress made key recommendations to address these weaknesses, according to a recent Government Accountability Office (GAO) report.
The report, issued in November, follows up on a 2006 GAO review of the FDA's process for monitoring the safety of marketed drugs. The report was requested by Rep. Henry Waxman, D-Calif., and Sen. Ted Kennedy, D-Mass., after the FDA approved the blockbuster pain drug Vioxx, only to pull it from the market in 2004 after it was linked to a high incidence of heart attack and stroke.
In its 2006 report, the GAO found that the FDA had not clearly defined the roles of two offices involved in making decisions about post-market safety—the Office of New Drugs
(OND) and the Office of Surveillance and Epidemiology (OSE). The GAO also expressed concerns about limitations in the data FDA relies on to identify post-market drug safety issues and the systems it uses to track such issues.
The GAO made a number of recommendations to address the problems it identified, including that FDA improve the independence of its program for resolving scientific disputes related to post-market drug safety. In 2007, legislation further expanded FDA's
But in following up on its earlier report, per the request of Sen. Charles Grassley, R-Iowa, the GAO found that the "FDA is beginning to address previously identified weaknesses in its oversight of post-market drug safety issues, but challenges remain."
Specifically, the FDA is changing its post-market decision-making process as part of its Safety First Initiative, which includes formalizing interactions between OND and OSE and providing OSE with added responsibilities. But the one authority FDA transferred from OND to OSE is a pre-market review responsibility, the GAO notes.
"FDA officials said the agency plans to transfer authority for two postmarket responsibilities for reviewing certain types of drug safety studies, but the agency does not have a timeframe for their transfer," the GAO says. "Officials said that OSE must still gain experience leading the one transferred responsibility and expand its staff before it can assume these additional responsibilities. While most of the OSE and OND employees GAO interviewed indicated that OSE's role in managing safety issues has increased since 2006, most OSE employees GAO interviewed said that OND's perspective still carries more weight in decision-making."
According to the report, OND recently created safety management positions in each of its 17 divisions; OSE expanded its similar positions from 9 to 25, although an employee said turnover has made it difficult for the OSE managers to gain experience.
"FDA is also revising its program for resolving scientific disputes, but these changes have not increased its independence, as GAO recommended," the report points out.
The FDA plans to implement new data systems and is increasing access to external data to assist with drug safety decisions, the report continues. The agency plans to implement new systems in 2010 to improve the timeliness, quality, and analysis of reports of adverse events associated with human drug use. The FDA has also increased funding for contracts with private companies and is in the early stages of forming partnerships with federal data holders to access external data.
"As mandated in the 2007 legislation, FDA is developing the Sentinel System, a network of external data providers intended to enhance drug safety surveillance, but the agency is in the early stages of developing it," the GAO notes.
Finally, the report found that the FDA is still barely treading water when it comes to meeting an expanded workload. In fact, FDA officials told the GAO that expanded responsibilities resulting from the 2007 legislation increased its workload, and both OND and OSE employees described difficulties meeting their responsibilities. The FDA indicated that since fiscal year 2008, OND staff increased from 736 to 928 and OSE staff increased from 114 to 193. However, an agency review suggests that OSE may still need to more than double its staff of 193 by fiscal year 2011 to meet its new responsibilities, the report states.
"Although OSE has increased its staff, officials cited hiring challenges, such as competition from the private sector, that may make it difficult to hire staff quickly enough to meet the increasing workload," the GAO states. "FDA also expects to complete a growing number of drug safety studies, but technological and staffing challenges limit its capacity to conduct these studies. To assist its decision-making, FDA has increasingly sought advice from members of its external drug safety advisory committee. However, the agency has encountered difficulty filling several committee vacancies. An official said FDA is reviewing candidates with the goal of filling these vacancies as soon as possible."
In short, while the FDA has acted on some of the GAO's 2006 recommendations, "this has not moved along very quickly," admits Marcia Crosse, director of healthcare at the GAO."We want to maintain some focus on this, to essentially say 'yes, you have made progress, but we believe this component is still lacking," Crosse says.
That component, at the forefront of the GAO's new recommendations, involves the FDA's development of a comprehensive plan to prepare OSE for the transfer of additional regulatory authorities from OND. According to the report, the FDA agreed with the GAO's recommendation.
The FDA said it intends to give the OSE more responsibilities, but only after its nearly 200 employees gain the experience and resources needed to take on those tasks.
But while the GAO agrees that both funding and staff are important to the successful transfer of these regulatory authorities, the GAO notes that the FDA has the flexibility to align its resources in such a way as to ensure that post-market drug safety receives appropriate attention.
"The FDA has the resources to do it—it just got a huge supplemental and regular, annual appropriations increase this fiscal year," Crosse says. "However, these types of changes take time. Our main concern is the timeframe in which these changes occur."
For Grassley, those changes can't come soon enough, as his office issued a statement Dec. 9 saying simply, "No more time should be wasted at the FDA in establishing independence for its post-market surveillance."