A Government Accountability Office report critical of the FDA's oversight of safety after drugs reach patients may help resurrect the Food and Drug Administration Safety Act of 2005, S. 930 (type "S 930" in the search box after selecting "Bill Number"). The bill has been buried in the Senate Committee on Health, Education, Labor and Pensions for a year.
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Recent GAO Report Cited
Legislator Urges Action on FDA Drug Safety Oversight
By News Staff
S. 930 would establish a Center for Postmarket Drug Evaluation and Research, or CPDER, within the FDA. The center would track adverse health effects of drugs after they've been released for sale to patients and act quickly to pull the medications off the market, if indicated; inform patients and physicians about problems; and prevent potentially widespread deleterious effects.
If established by law, the CPDER would replace the current Office of Drug Safety, which is responsible for postmarket safety. The Office of Drug Safety, however, acts only as a consultant to the FDA Office of New Drugs, which approves new drugs.
Noting that the GAO report, "Drug Safety: Improvement Needed in FDA's Postmarket Decision-Making and Oversight Process," (PDF file: 67 pages / 790 KB. More about PDFs.) "identifies the kinds of problems I've been tracking and investigating for the last two years," Sen. Charles Grassley, R-Iowa, chair of the Senate Finance Committee, urged the Senate to act on S. 930. He made his comments in an April 24 statement (PDF file: 3 pages / 409 KB. More about PDFs.).
"The GAO describes an Office of Drug Safety that is underfunded, lacking independence and lacking decision-making responsibility," said Grassley. "This is unacceptable. … Officials from the Office of New Drugs -- which is responsible for approving or disapproving drug applications in the first place -- have responsibility for any regulatory action related to the safety of drugs already on the market. The conflict of interest is clear."
Under S.930, the CPDER would be responsible for
If established by law, the CPDER would replace the current Office of Drug Safety, which is responsible for postmarket safety. The Office of Drug Safety, however, acts only as a consultant to the FDA Office of New Drugs, which approves new drugs.
Noting that the GAO report, "Drug Safety: Improvement Needed in FDA's Postmarket Decision-Making and Oversight Process," (PDF file: 67 pages / 790 KB. More about PDFs.) "identifies the kinds of problems I've been tracking and investigating for the last two years," Sen. Charles Grassley, R-Iowa, chair of the Senate Finance Committee, urged the Senate to act on S. 930. He made his comments in an April 24 statement (PDF file: 3 pages / 409 KB. More about PDFs.).
"The GAO describes an Office of Drug Safety that is underfunded, lacking independence and lacking decision-making responsibility," said Grassley. "This is unacceptable. … Officials from the Office of New Drugs -- which is responsible for approving or disapproving drug applications in the first place -- have responsibility for any regulatory action related to the safety of drugs already on the market. The conflict of interest is clear."
Under S.930, the CPDER would be responsible for
- conducting postmarket risk assessment and drug surveillance research,
- contracting or requiring the drug's sponsor to contract with surveillance databases to conduct epidemiological studies,
- determining whether a drug presents an unreasonable health risk,
- taking corrective action if such a risk exists, and
- informing physicians and members of the public about risks in a timely manner.
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