In its latest bid to grapple with abuse and addiction problems caused by prescription painkillers, the FDA has enlisted the assistance of the Clinical Trials Transformation Initiative, a think tank created by the agency with academic and industry participation.
As the think tank has done in the past, the purpose will be to help formulate ideas for designing clinical trials for opioids that can minimize the problems that have led to a nationwide debate over the benefits and risks of prescription painkillers.
The decision, which will be announced later this week, comes after the FDA earlier this year issued a draft guidance that attempts to help drugmakers determine which studies should be conducted to develop medicines to thwart abuse and the labeling claims that the agency may approve (back story with a link to the guidance).
The FDA “is asking CTTI to help with the opioid situation as they have with other situations,” said Rachel Sherman, associate director for medical poliy at the FDA Center for Drug Evaluation and Research. She disclosed the move while speaking at a Rutgers Business School conference on healthcare.
The debate over prescription painkillers has prompted a number of reactions from policymakers and regulators. Recently, a bill was introduced in Congress to move medications than contain hydrocodone, such as Vicodin, to a more restrictive ranking on the law enforcement schedule (read here).
Last year, the US Senate Finance Committee opened an investigation into several drugmakers – including Johnson & Johnson (JNJ), Purdue Pharma and Endo Pharmaceuticals (ENDP) - patient advocacy groups over marketing efforts to boost opioid prescribing (back story).
And last month, the FDA decided not to approve generic versions of the older form of OxyContin over concerns that the drugs would be susceptible to abuse. The patent on the brand-name pill, which is sold by Purdue, had just expired and several drugmakers sought to launch lower-cost copycat version (read more here).
The FDA received some criticism over that decision, which was seen as a gift for Purdue, which had pled guilty six years ago and paid a $634 million fine for misbranding OxyContin and misleading regulators, physicians and consumers about the risks of the painkiller.
The drugmaker has been selling a newer, tamper-resistant version since 2010. At the time, Purdue halted shipments in the US of the older OxyContin. In fact, the FDA also approved labeling that this version is less prone to abuse. As a result, Purdue will not face any competition for OxyContin in the US.
However, Sherman defended the agency decision by noting that “there is an epidemic of drug abuse in this country. When a safer alternative becomes available, we try to get rid of the less-safe alternative,” she said. “We do not want to expose people to undue risk… It’s a delicate balance.”
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