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Test Subject Dies While Taking Experimental Drug

A man taking part in a French drug trial died in January while undergoing treatment with an experimental painkiller drug. He was one of 90 healthy men who had volunteered to be tested with the drug, which was being developed by Bial, a Portuguese pharmaceuticals company. The volunteers were given the medication in differing amounts, and at different times. In all, six test subjects had to be hospitalized, and it was feared that three of them might have suffered brain injuries from the medication. Other test subjects had been treated in clinical trials before this group, with no major adverse reactions.

FDA Announces Changes to Its Opioid Drug Policies

On Feb. 4, Dr. Robert Califf, the FDA's Deputy Commissioner for Medical Products and Tobacco, announced measures the agency planned to take in an effort to address the growing opioid abuse problem in the United States while preserving access to opioid medications for patients who really need them. “We are determined to help defeat this epidemic through a science-based and continuously evolving approach,” said Califf. “This plan contains real measures this agency can take to make a difference in the lives of so many people who are struggling under the weight of this terrible crisis.”

On March 15, the action plan was announced. It includes:

  • Expanded use of advisory committees.
  • Development of warnings and safety information for immediate-release opioid labeling.
  • Strengthening of postmarket requirements to require drug companies to follow patients and obtain data on the long-term impacts of opioid use.
  • Updating the Risk Evaluation and Mitigation Strategy (REMS) Program for opioid makers, to improve the continuing medical education (CME) courses they fund for providers so that prescribers of such medications are better trained in safe prescribing practices.
  • Expanding access to abuse-deterrent formulations (ADFs) to discourage abuse.
  • FDA review of options to deal with overdose, including the possibility of over-the-counter availability of naloxone, which can quickly counteract the effects of opioid overdose.
  • Reassessment of the risk-benefit approval framework for opioid use.

See http://1.usa.gov/1W6x1by.

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