The FDA's move to put tighter controls on combo pain drugs like Vicodin that contain hydrocodone with over-the-counter painkillers like aspirin have it again balancing its role as a regulator concerned about the safety and effectiveness of drugs with growing concerns about overdose deaths and addition.
Which doctors to flag for reckless OxyContin prescribing may soon be a decision that's out of maker Purdue Pharma's hands, at least in California. Thursday, a spokesman from Purdue Pharma confirmed that the company had turned over a list of 49 California doctors it suspected of risky script-writing to the Medical Board of California.
California is pushing some new legislation that drugmakers and physicians were none too happy with in its original form. But after some amendments, a slate of reforms to increase authorities' powers to crack down on risky narcotics prescribers has made its way to the desk of Gov. Jerry Brown. The three bills now await his signature to make them law.
Now that Purdue Pharma has acknowledged news reports that it compiled a list of 1,800 doctors suspected of churning out OxyContin prescriptions for addicts and drug dealers, the political fallout has begun.
Purdue Pharma has a database of doctors who prescribe a lot of its painkiller OxyContin. On the face of it, that's not much of a statement, but in this case, the list of more than 1,800 comprises doctors suspected of recklessly writing scripts for addicts and drug dealers, the Los Angeles Times reports.
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.