Disorganization, bureaucratic infighting and an inability to force drug makers to conduct needed safety tests have undercut efforts at the Food and Drug Administration to uncover drug dangers, U.S. government auditors said in a report being released Monday.
When drug safety specialists raise alarms about certain medicines, they sometimes feel that their recommendations fall "into a 'black hole' or 'abyss'" at the agency, according to the report by the Government Accountability Office.
Agency officials sometimes excluded drug safety specialists from presenting findings at public hearings, and tensions between officials who approve drugs and those who ensure that they are safe are common, the report said.
The agency "lacks clear and effective processes for making decisions about, and providing management oversight," of issues involving the safety of popular medicines, the report stated.
The agency told the accountability office that its conclusions were "reasonable," the report said.
Last year, the agency created a drug safety oversight board and asked the Institute of Medicine to examine its drug safety practices. The institute's report is due in July.
The accountability office said the agency's responses so far might help, "but will not address all gaps."
Susan Bro, a spokeswoman for the Food and Drug administration, said it welcomed the accountability agency's audit and was "currently leading a comprehensive and timely effort to transform the methods our medical and scientific staff use to manage safety issues."
The report comes after a series of withdrawals of drugs from the market led critics of the agency and some in Congress to suggest that the agency was failing in its mission to protect the public from dangerous drugs.
When it approves new drugs for sale, the drug agency often requires manufacturers to study whether the medicines are working as intended and whether they have unwanted side effects once they get into a broader market.
But the agency announced in March that two-thirds of these promised studies had not been started. Hundreds of trials have been pending for years.
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Flaws found in approval process for drugs in U.S.
By Gardiner Harris The New York Times
MONDAY, APRIL 24 2006
http://www.iht.com/articles/2006/04/24/news/fda.php
When drug safety specialists raise alarms about certain medicines, they sometimes feel that their recommendations fall "into a 'black hole' or 'abyss'" at the agency, according to the report by the Government Accountability Office.
Agency officials sometimes excluded drug safety specialists from presenting findings at public hearings, and tensions between officials who approve drugs and those who ensure that they are safe are common, the report said.
The agency "lacks clear and effective processes for making decisions about, and providing management oversight," of issues involving the safety of popular medicines, the report stated.
The agency told the accountability office that its conclusions were "reasonable," the report said.
Last year, the agency created a drug safety oversight board and asked the Institute of Medicine to examine its drug safety practices. The institute's report is due in July.
The accountability office said the agency's responses so far might help, "but will not address all gaps."
Susan Bro, a spokeswoman for the Food and Drug administration, said it welcomed the accountability agency's audit and was "currently leading a comprehensive and timely effort to transform the methods our medical and scientific staff use to manage safety issues."
The report comes after a series of withdrawals of drugs from the market led critics of the agency and some in Congress to suggest that the agency was failing in its mission to protect the public from dangerous drugs.
When it approves new drugs for sale, the drug agency often requires manufacturers to study whether the medicines are working as intended and whether they have unwanted side effects once they get into a broader market.
But the agency announced in March that two-thirds of these promised studies had not been started. Hundreds of trials have been pending for years.
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Flaws found in approval process for drugs in U.S.
By Gardiner Harris The New York Times
MONDAY, APRIL 24 2006
http://www.iht.com/articles/2006/04/24/news/fda.php
