FDA Postmarket Rx Safety Surveillance Insufficient, GAO Finds
FDA "lacks a clear and effective process" for tracking safety issues related to approved drugs, according to a Government Accountability Office report released on Monday, USA Today reports (Rubin, USA Today, 4/24).
For the report, which was requested in 2004 by Sen. Chuck Grassley (R-Iowa) and Rep. Joe Barton (R-Texas), researchers examined the agency's handling of four controversial drugs -- statin Baycol, painkiller Bextra, rheumatoid arthritis medication Arava and nighttime heartburn treatment Propulsid -- and concluded that "there is a lack of criteria for determining what safety actions to take and when to take them" (Kaufman, Washington Post, 4/24).
The report "comes after a series of drug withdrawals led agency critics and some on Capitol Hill to suggest that the agency was failing in its mission to protect the public from dangerous drugs," the New York Times reports (Harris, New York Times, 4/24). Of the four drugs examined, all but Arava were eventually taken off the market because of safety concerns.
The report found that disputes between FDA's Office of Drug Safety and Office of New Drugs slowed the evaluation process, the Post reports (Washington Post, 4/24). The new drug office reviews medicines before they go on the market, while the drug safety office focuses on postmarket safety (Wilde Mathews, Wall Street Journal, 4/24).
According to the report, "ODS serves primarily as a consultant to OND," and OND sometimes has excluded ODS analyses at advisory committee meetings (USA Today, 4/24). ODS has "no independent decision-making responsibility," the report states (Wall Street Journal, 4/24). In addition, the report says ODS officials sometimes feel that their recommendations fall "into a 'black hole' or 'abyss'" at the agency (New York Times, 4/24).
According to the report, the management of ODS "has not effectively overseen postmarket drug safety issues, and, as a result, it is unclear how FDA can know that important safety concerns have been addressed and resolved in a timely manner" (Blum, Bloomberg/Arizona Daily Star, 4/24).
The report also finds that although FDA sometimes requests that drug makers conduct postmarket safety studies as a condition of approval, only about 25% of such studies were completed between 1991 and 2003 (USA Today, 4/24). The report states, "One senior FDA official and several outside drug safety experts told us that FDA needs greater authority to require such studies."
GAO also found that FDA's budget for its own drug safety studies was less than $1 million per year from 2002 to 2005 and was expected to increase to $1.1 million annually through 2010, while a single clinical trial can cost as much as $7 million (New York Times, 4/24).
In addition, the report finds that since 2000, 10 drugs have been removed from the market for safety reasons, all of which were withdrawn voluntarily by the manufacturers (Bloomberg/Arizona Daily Star, 4/24).
Both ODS and OND are part of FDA's Center for Drug Evaluation and Research. The report recommends that FDA clarify the safety office's role (USA Today, 4/24). FDA established a dispute-resolution procedure in 2004, but GAO said it has not been used and could need changes.
In addition, the agency's new Drug Safety Oversight Board, which was established in 2005, might have only limited ability to give "neutral, independent advice" when resolving disputes because it consists largely of FDA officials, the report finds (Wall Street Journal, 4/24).
GAO also recommends that Congress consider expanding FDA's authority to require pharmaceutical companies to conduct postmarket safety studies, USA Today reports. Grassley and Sen. Chris Dodd (D-Conn.) have sponsored a bill that would create an FDA Center for Postmarket Drug Evaluation and Research that would have authority equal to that of CDER (USA Today, 4/24).
Grassley said, "This report provides solid evidence that everything is not all right at the FDA and calls for long-overdue reform. The FDA's problems are systemic and cultural, not isolated or easily fixed" (Bridges, AP/Miami Herald, 4/24). Grassley added that the report supports "what everybody seems to know, that the FDA needs reform, that things that go on in the FDA don't really protect the consumer. The FDA is kind of a Good Housekeeping seal of approval on drugs, and really, it's questionable (whether) they should have that honor" (USA Today, 4/24).
A spokesperson for Barton said he would wait for a related National Academy of Sciences report to be released this summer before deciding whether to pursue legislation. Barton said, "The GAO report shows that the drug safety system is not in crisis, but the FDA's process may need some fine-tuning" (Alonso-Zaldivar, Los Angeles Times, 4/24). He added, "Prescription drugs approved by the FDA should keep you out of the hospital, not send you to one" (USA Today, 4/24).
FDA told GAO that its conclusions were "reasonable," according to the report. FDA spokesperson Susan Bro said, "The FDA welcomes the GAO report and is currently leading a comprehensive and timely effort to transform the methods our medical and scientific staff use to manage safety issues" (New York Times, 4/24).
Caroline Loew, senior vice president of the Pharmaceutical Research and Manufacturers of America, said the group "believes that the FDA takes postmarket surveillance of prescription drugs seriously and has taken additional steps over the past couple of years to help ensure that patient safety cannot be compromised," adding that only 3% of all approved drugs have been later withdrawn (Washington Post, 4/24).
Arthur Levin, head of the Center for Medical Consumers, said "I wish [the report] had gone further," adding that FDA needs "not just more authority, but more authority with clout."
Sidney Wolfe, head of Public Citizen's Health Research Group, said the current relationship between ODS and OND results in a "dangerous imbalance of power between postmarket safety and the reviewing decision." Public Citizen said GAO's recommendations were "necessary, but grossly insufficient" (USA Today, 4/24).