For months FDA regulators have been wrestling with the dangers of allowing a flood of cheap, generic version of the highly addictive OxyContin on the market vs. consumers with pain issues having access to cheaper meds.
Purdue's original patent on the superpotent and often abused painkiller OyxContin expires tomorrow, and drugmakers are jockeying for a piece of its $2.8 billion market share. But the FDA is under increasing pressure to require generic drugmakers to make their formulations tamper-resistant.
The FDA is enmeshed in a process to find the right balance on how to approve and regulate addictive painkillers and a vote expected today is just one small piece of that puzzle-piecing exercise.
Endo Health Solutions' ($ENDO) attempt to outmaneuver generic competition by kicking dirt all over its own product has come up short. A federal judge in Washington declined to force the FDA to declare the original formulation of Endo's pain drug Opana ER unsafe.
Here's another wrinkle in the debate over generic painkillers. Less than a week after Endo Health Solutions ($ENDP) sued the FDA to block cheap copies of non-tamper-resistant versions of its Opana pill, the White House is warning police and border officials to watch out for generic versions soon to be available in Canada.
On one side stand Endo Health Solutions ($ENDP) and Purdue Pharma. On the other, generic drugmakers that want to introduce copies of big-selling, high-powered painkillers. In the middle, the FDA, which has to decide whether to allow those cheap copies onto the market.
Transcept Pharmaceuticals and Purdue Pharma are planning huge new DTC blitz for their new insomnia drug Intermezzo, which has languished since its debut in April.
Whether essentially ending the pharma careers of three former Purdue Pharma executives will provide any kind of real deterrent to other drug company CEOs inclined to bending the law, is yet to be seen. Still the U.S. has the right to do it, an appeals court says.
On the heels of new addiction-fighting measures from FDA, Congressional reps are introducing a bill that would put the onus on drugmakers to curb abuse. The measure would require pain drugs to be formulated to deter abuse.
Purdue Pharma isn't counting on its aggressive patent litigation to extend its monopoly on OxyContin. It has a fallback plan. To qualify for 6 months' worth of extra exclusivity, Purdue is conducting a pediatric trial, testing the powerful painkiller in 150 children.