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Two House leaders yesterday demanded the FDA provide them with a massive number of agency records related to the potential for increased risk of suicide in children taking antidepressant drugs and to whether an FDA official was prevented from presenting his findings at an advisory committee meeting in February.
The FDA and the Drug Enforcement Administration (DEA) are developing new, more explicit labeling guidelines for manufacturers of controlled substances like Purdue Pharma’s OxyContin and Abbott Laboratories’ Vicodin in an effort to curb widespread abuse of the prescription painkillers.
FDA Commissioner Mark McClellan last week fired off a letter urging Canadian authorities to more aggressively regulate internet pharmacies in the wake of a Minnesota study that found safety violations at several sites.
New guidelines issued by the Health Industry Group Purchasing Association (HIGPA), which represents 175 healthcare purchasing and supply chain organizations, could help strengthen drugmakers’anticounterfeiting efforts.
The leader of a key subcommittee in the U.S. House of Representatives is investigating allegations that drugmakers have suppressed clinical trial data that shows increased risk of suicide in children who are treated with antidepressants.
While one group of U.S. researchers recently released a report finding that antidepressants like Prozac, Zoloft and Paxil do not raise the risk of suicide in children, other researchers claimed last week that drug companies’ refusal to release details of negative studies denies physicians and parents critical information needed to assess the safety of such drugs.
The FDA’s guidance on risk management plans (RMPs) for controlled substances that could be categorized by the Drug Enforcement Administration (DEA) as schedule II drugs should encourage manufacturers submitting new drug applications to include plans for monitoring their use and identifying potential abuse and diversion problems, according to the General Accounting Office (GAO).
Antidepressants like Prozac, Zoloft and Paxil do not raise the risk of suicide in children, a group of U.S. researchers said in a report released just weeks before an FDA advisory panel is scheduled to discuss safety concerns about the drugs.
The FDA must review and improve risk management plans (RMPs) for all controlled substances that could potentially be categorized by the Drug Enforcement Administration (DEA) as schedule II drugs, according to a recent General Accounting Office (GAO) report.