FDA Wants Help on Think Tank for Opioid Trials
May 2nd, 2013 // 12:56 pm @ jmpickett
FDA wants the help of the Clinical Trials Transformation Initiative to help it deal with the problems of abuse and addiction that are being caused by prescription painkillers. That Initiative is a think tank that was created by FDA with the help of both academic and industry stakeholders.
As in the past with this think tank, the idea is to help come up with ideas to set up clinical trials for opioids that can cut down on problems that have caused a debate across the US about the benefits/risks of these painkillers.
The decision will be announced by the end of this week. It comes after the agency in February came out with a new draft guidance that tries to help pharmaceutical companies figure out which clinical studies should be done to come up with medicines to cut down on abuse.
FDA is asking CTTI to help them with the opioid problem just as they have in other areas, according to the associate director for medical policy at CDER.
The debate on Rx painkillers has caused several legislative actions from regulators and policymakers. A bill was introduced on the Hill recently that would put drugs that have hydrocodone, including Vicodin, to a ranking with more restrictions on the schedule for law enforcement.
In 2012, the Senate Finance Committee in the US started an investigation into J&J, Purdue Pharma and Endo Pharmaceuticals regarding marketing efforts to increase the prescription of opioids.
In March, FDA declined to approve a generic version of old OxyContin because it was feared the new drug could be easily abused. The patent on the brand name drug had expired and several companies wanted to come out with a cheap, generic version. FDA said no.
FDA has gotten some heat over that call. It was seen by some as a gift to Purdue. That company pleaded guilty in 2006 and paid a $630 million fine for the misbranding of Oxycontin and for misleading doctors, consumers and FDA regulators about the dangers of the drug.
Purdue has sold a more tamper resistant version of OxyContin for 3 years. Purdue stopped shipments of the old drug at that time. FDA also has approved new labeling that say the new version is less prone to being abused. Purdue won’t have any competition for Oxycontin in the United States.
Still, FDA has defended its decision. FDA says that there is a major epidemic of prescription drug abuse in the US. When a safer option becomes available, FDA wants to get rid of the less safe option.
