Senator Urges Consideration of Bills on FDA Oversight
Senate Finance Committee Chair Chuck Grassley (R-Iowa) on Monday urged lawmakers to consider legislation that would address FDA's postmarket regulation of approved drugs, CongressDaily reports. Responding to a Government Accountability Office report released Monday, Grassley touted his bill (S 930), co-sponsored by Sen. Christopher Dodd (D-Conn.), which would authorize FDA to conduct postmarket drug reviews (CongressDaily, 4/25).
The GAO report said FDA "lacks a clear and effective process" for tracking safety issues related to approved drugs. GAO researchers concluded that "there is a lack of criteria for determining what safety actions to take and when to take them" and found that disputes between FDA's Office of Drug Safety and Office of New Drugs slowed the evaluation process.
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" (California Healthline, 4/24).
Grassley said the bill would increase transparency at FDA, which he said is "underfunded, lacking in independence and lacking in decision-making responsibility" (CongressDaily, 4/25). Grassley said FDA "remains an agency in denial when it comes to the problems addressed in this new report." He added that he would leave the markup of a bill to the Senate Health, Education, Labor and Pensions Committee, which has jurisdiction, and provide only oversight in his role as Finance chair (Schuler, CQ Today, 4/24).
Grassley said he was "reluctant to pre-empt" the HELP Committee but added that there might be other vehicles for his proposals (CongressDaily, 4/25).
Senate HELP Committee Chair Mike Enzi (R-Wyo.) said he and Sen. Edward Kennedy (D-Mass.) are working to draft their own "comprehensive drug safety legislation soon."
FDA spokesperson Susan Bro said FDA is working to address some of the report's findings, adding that FDA "welcomes the GAO report and is currently leading a comprehensive and urgent effort to transform the methods our medical and scientific staff use to manage safety issues associated with prescription medicine use in the U.S." (Heavey, Reuters/Washington Post, 4/24).
Newspapers published two editorials and an opinion piece that addressed the GAO report and Grassley's efforts. Summaries appear below.
Boston Globe: The creation of an independent drug safety board "might be required at some point, but in the meantime Congress should pass the Grassley-Dodd bill," a Globe editorial states. It says, "The measure is an overdue corrective for the pressure that drug makers in recent years have put on the FDA and Congress to let them bring drugs to the market more quickly." The editorial concludes, "The public should not have to pay for greater regulatory efficiency with damaging and in some cases fatal side effects" (Boston Globe, 4/25).
New York Times: The GAO report shows that "reforms are badly needed" at FDA, which is "often sluggish in responding to danger signals" and also "lacks the legal authority to require manufacturers to conduct needed safety studies," a Times editorial states. It adds that the findings are "serious," and "partial reforms now being put into place will not suffice." The editorial concludes, "If this GAO report does nothing else, it ought to prod Congress to expand the FDA's authority to force manufacturers to conduct needed postmarket studies" (New York Times, 4/25).
- Sharon Brownlee, Los Angeles Times: A new "Institute for Effective Medicine" modeled after "the Federal Reserve Board or the Securities and Exchange Commission to protect it from political pressure" is needed to study the safety and effectiveness of drugs, Brownlee, a senior fellow at the New America Foundation, writes in a Times opinion piece. She says the new institute's mission "would be threefold" -- it would "serve as a new, independent source of research dollars for medicine"; it would "provide independent evaluation of data generated by industry"; and it would "oversee the creation of clinical practice guidelines, a manual of proven 'best practices' for physicians devised entirely without industry influence." She concludes, "Congress may be reluctant to fund a new agency -- particularly one the drug industry may hate -- but an Institute for Effective Medicine would be worth its freight in better health care and lower costs" (Brownlee, Los Angeles Times, 4/25).
Two broadcast programs reported on the study:
- APM's "Marketplace": The segment includes comments from Grassley; Art Levin, director of the Center for Medical Consumers; and Alistair Wood, a drug safety expert from Vanderbilt University (Palmer, "Marketplace," APM, 4/24). A transcript of the segment is available online. The complete segment is available online in RealPlayer.
- CBS' "Evening News": The segment includes comments from Steven Nissen, a cardiologist at the Cleveland Clinic (Kaledin, "Evening News," CBS, 4/24). The complete segment is available online in RealPlayer.