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| Endo Pharmaceuticals petitioned the FDA to require tamper-resistant generics--courtesy of Endo Pharmaceuticals |
The FDA's path through the swamp of painkiller abuse advanced a bit on Friday. An advisory panel backed new controls on hydrocodone drugs, including cough medications and pain pills. The committee recommended prescription limits, in a 19-10 vote, in an effort to tighten up access.
The FDA doesn't always follow the advice of its outside experts, but it usually does. The split vote opens up the question a bit, however. As The New York Times reports, some of the panelists were skeptical that new limits would forestall abuse of the drugs. The same limits already apply to oxycodone products--including the notoriously abused OxyContin.
Plus, the agency recently decided that non-tamper-resistant copies of OxyContin and similar drugs could be sold, even though the branded versions are no longer on the market in their old, easily abused formulations. Endo Pharmaceuticals ($ENDP), which makes an oxycodone drug, Opana, had petitioned the FDA to require the generics to be tamper-resistant, as its new Opana product is. The agency decided that patient access to pain relief was more important. (Endo then sued FDA, but a judge declined to force the agency's hand.)
But that's not to say that FDA isn't keen on preventing abuse. The agency is convening a two-day meeting next month to consider prescribing guidelines for opioid drugs. And earlier this month, the FDA issued guidance for makers of tamper-resistant pills.
- read the NYT piece