Purdue Pharma and generic drugmaker Actavis have settled their patent suit over a special formulation of the painkiller OxyContin just 10 days the FDA banned generic versions that do not carry abuse resistant technology.
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 $2.8 billion market share. But the FDA is under increasing pressure to require generic drugmakers to make their formulations tamper-resistant.
An FDA advisory panel backed new controls on hydrocodone drugs, including cough medications and pain pills. The committee recommended prescription limits, in a 19-10 vote, in an effort to tighten up access.
The FDA is enmeshed in a process to find the right balance on how to approve and regulate addictive painkillers and a vote expected today is just one small piece of that puzzle-piecing exercise.
Endo Health Solutions' ($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.
There is abuse of power and then there is power over abuse and that is what an FDA panel exercised Friday when they recommended against a stronger form of hydrocodone from Zogenix ($ZGNX), citing its potential for illegal use by drug addicts.
Here's another wrinkle in the debate over generic painkillers. Less than a week after Endo Health Solutions ($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.
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.