White House adds voice to debate over generic painkillers
Here's another wrinkle in the debate over generic painkillers. Less than a week after Endo Health Solutions ($ENDP) sued the FDA to block cheap copies of non-tamper-resistant versions of its Opana pill, the White House is warning police and border officials to watch out for generic versions soon to be available in Canada.
"The potential exists for diversion into the United States because the old formulations, which are easier to abuse, are unavailable in the United States," the alert from the White House Office of National Drug Control Policy stated (as quoted by The Wall Street Journal).
Patents on the old formulations of Endo's Opana and Purdue Pharma's OxyContin are soon to expire. Generics makers already have the right, under a patent settlement with Endo, to roll out copies of Opana's original formula. OxyContin's patent runs out in April. Both drugmakers have pulled their original branded versions in favor of the new, crush-resistant formulations they developed. Generics of the old-style pills could severely cannibalize the new versions' sales.
So, copycat drugmakers are lining up to sell versions of the big-selling drugs, while Purdue and Endo are fighting to keep them out, saying the FDA shouldn't allow non-tamper-resistant versions to be sold. Purdue has said it's worried about Canada's approval of generics, predicting a "resurgence in abuse," the WSJ says. And some in Congress agree; according to the WSJ, Rep. Harold Rogers met privately with the FDA last week to argue against the generics.
- read the WSJ piece (sub. req.)
Should FDA usher old-style opioid generics onto the market?
New bill aims to mandate abuse-deterrent painkillers
OxyContin abuse overshadows formulation fix
Purdue, Endo answer calls to deal with painkiller abuse
Purdue Pharma's OxyContin reformulated to thwart abusers