The Food and Drug Administration will not approve generic versions of Purdue Pharma's painkiller OxyContin based on earlier versions of the drug that did not include features to thwart abuse, the agency said.
Purdue Pharma's patent for OxyContin expired Tuesday, opening up the opioid painkiller to generic competition, but authorities have raised concerns about what they call the potential for generic versions to be abused.
Generic makers heralded the fiscal year 2014 budget proposed last week by the Obama administration for its embrace of generic drugs, but were critical of its provisions on patent settlements and rebates.
The governor of North Dakota has signed into law a bill that would require pharmacy benefit managers to inform pharmacies about how reimbursement for generic prescription drugs is calculated under maximum allowable cost benchmarks and provide a more detailed appeals process to pharmacies to contest the MAC reimbursement caps that PBMs set up.
A proposal to further reduce Medicaid drug reimbursement that was included in President Obama’s fiscal year 2014 budget plan is “premature” and federal Medicaid officials should focus on modifying and completing already proposed regulations to set future federal upper limits for reimbursement of most generic drugs, the National Association of Chain Drug Stores and the National Community Pharmacists Association said.