Healthy Skepticism Library item: 4511
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Mathews A.
Congressional Report Assails FDA on Drug Safety
The wall street journal 2006 Apr 24
http://online.wsj.com/article_email/SB114584152141633740-lMyQjAxMDE2NDI1NDgyNDQxWj.html
Notes:
Ralph Faggotter’s Comments:
“ The report also said that Congress should consider giving the FDA more power to order drug companies to do safety studies of medications already on the market.”
This is a necessary change, since pharmaceutical companies often promise to do follow-up safety studies as a condition of a new drug approval, but never actually get around to doing the studies!
Even better, funding should be provided to independent objective researchers to do the same thing.
Full text:
Congressional Report Assails FDA on Drug Safety
By ANNA WILDE MATHEWS
April 24, 2006; Page A3
WASHINGTON — Congressional investigators criticized the Food and Drug Administration’s handling of drug-safety issues, reiterating concerns that gained prominence in the past few years with worries about some widely used drugs.
Overall, the Government Accountability Office said, the FDA “lacks a clear and effective process for making decisions about, and providing management oversight of” drug-safety issues that arise after a medicine is on the market. The request for the report was sparked by high-profile safety issues of the past few years, including concerns about antidepressants and the 2004 withdrawal of Merck & Co.‘s painkiller Vioxx from the market.
The GAO report is set to be unveiled today by Sen. Charles Grassley, the Iowa Republican who is chairman of the Senate Finance Committee, and Rep. Joe Barton, the Texas Republican who heads up the House Energy and Commerce Committee. It may add momentum to stalled efforts to pass new drug-safety legislation, perhaps tied to next year’s must-pass renewal of the FDA’s industry user-fee program.
In a statement, Mr. Grassley, who has introduced a drug-safety bill, said the agency’s “problems are systemic and cultural, not isolated or easily fixed.” Mr. Barton said the drug-safety system is “not in crisis, but the FDA’s process may need some fine-tuning” and the agency has “taken some steps to address the concerns raised by the GAO.”
The FDA said it is already “leading a comprehensive and timely effort to transform the methods” the agency uses to manage safety issues with prescription medicines. The agency said “many significant reforms have already taken shape and are leading to improvements in how we communicate drug benefit and safety information” to doctors and patients. But investigators said that some planned improvements haven’t been fully implemented and the agency and Congress could do more.
The GAO report focused on the relationship between the FDA’s Office of New Drugs, which reviews medicines before they go on the market and has primary responsibility for them, and the Office of Drug Safety, which focuses on safety of medicines after they are approved. The report said the safety office served as a “consultant” to the new-drugs office, with no “independent decision-making responsibility.” Some drug-safety staff told the investigators their recommendations fell into a “black hole” or an “abyss.”
The GAO report also cited examples — which had previously been made public — in which the new-drugs office didn’t allow officials from the drug-safety office to speak publicly about their conclusions before outside advisory committees examining the drugs.
Because of tension over such incidents and others, the FDA established a new dispute-resolution procedure in November 2004, but the GAO said it has yet to be used and may need changes to “increase its independence.” The FDA’s new Drug Safety Board, established last year and consisting largely of agency officials, may have only a limited ability to give “neutral, independent advice” in resolving clashes, the report said.
The report also said that Congress should consider giving the FDA more power to order drug companies to do safety studies of medications already on the market. The agency lacks “broad authority” to demand that, the GAO wrote.
Write to Anna Wilde Mathews at anna.mathews@wsj.com
