FDA's safety reform is greeted with scepticism
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《英国医生杂志》
The US consumer watchdog group Public Citizen has described the creation of a new safety body at the Food and Drug Administration as a "desperate" and "cynical" attempt to respond to public alarm about the harms of prescription drugs.
Last week the FDA announced that it will set up a new drug safety oversight board, made up of experts from government agencies, including the FDA, to "oversee the management of drug safety issues" and provide information to doctors and patients more quickly than in the past. The board will not get involved in assessing drugs before approval but will concentrate on improving the way the FDA monitors and disseminates information about adverse events.
The move comes after a series of controversies involving the safety of hormone replacement therapy, antidepressants, antiarthritis drugs, and, most recently, a drug used to treat attention deficit hyperactivity disorder, atomoxetine, which has been linked to rare but serious liver problems. The controversies have raised serious questions about the independence of the US drug regulator and led to congressional investigations.
Dr Sidney Wolfe, director of Public Citizen's health research group in Washington, DC, said that the new board would only be an advisory body, relying on information from the FDA's Center for Drug Evaluation and Research, which itself stands accused of being too slow to move on safety and too close to one of its major sponsors, the drug industry. Dr Wolfe said that the new board will be a "toothless tiger" unless the opinions of the FDA's Office of Drug Safety are given more weight and enabled to prevail.
In Britain the Committee on Safety of Medicines and the government's Medicines and Healthcare Products Regulatory Agency have both come under public criticism in recent years, particularly over the slowness to uncover the dangers of withdrawal and suicidal behaviour associated with selective serotonin reuptake inhibitors.
Dr David Healy, a psychiatrist at the University of Wales, said that nothing would change significantly anywhere until the raw data from clinical trials of drugs were made publicly available.
In Australia the post-marketing surveillance of drugs is handled by the Adverse Drug Reactions Advisory Committee, which is made up of independent researchers who advise the national regulator.
David Henry, professor of pharmacology at the University of Newcastle, New South Wales, says he doesn't believe the Australian system needs the same reform as the US system because there is more separation between those who approve drugs and those who subsequently monitor their safety. (See p 440.)(Ray Moynihan)
Last week the FDA announced that it will set up a new drug safety oversight board, made up of experts from government agencies, including the FDA, to "oversee the management of drug safety issues" and provide information to doctors and patients more quickly than in the past. The board will not get involved in assessing drugs before approval but will concentrate on improving the way the FDA monitors and disseminates information about adverse events.
The move comes after a series of controversies involving the safety of hormone replacement therapy, antidepressants, antiarthritis drugs, and, most recently, a drug used to treat attention deficit hyperactivity disorder, atomoxetine, which has been linked to rare but serious liver problems. The controversies have raised serious questions about the independence of the US drug regulator and led to congressional investigations.
Dr Sidney Wolfe, director of Public Citizen's health research group in Washington, DC, said that the new board would only be an advisory body, relying on information from the FDA's Center for Drug Evaluation and Research, which itself stands accused of being too slow to move on safety and too close to one of its major sponsors, the drug industry. Dr Wolfe said that the new board will be a "toothless tiger" unless the opinions of the FDA's Office of Drug Safety are given more weight and enabled to prevail.
In Britain the Committee on Safety of Medicines and the government's Medicines and Healthcare Products Regulatory Agency have both come under public criticism in recent years, particularly over the slowness to uncover the dangers of withdrawal and suicidal behaviour associated with selective serotonin reuptake inhibitors.
Dr David Healy, a psychiatrist at the University of Wales, said that nothing would change significantly anywhere until the raw data from clinical trials of drugs were made publicly available.
In Australia the post-marketing surveillance of drugs is handled by the Adverse Drug Reactions Advisory Committee, which is made up of independent researchers who advise the national regulator.
David Henry, professor of pharmacology at the University of Newcastle, New South Wales, says he doesn't believe the Australian system needs the same reform as the US system because there is more separation between those who approve drugs and those who subsequently monitor their safety. (See p 440.)(Ray Moynihan)