The U.S. Federal Circuit’s denial Feb. 11 of an en banc rehearing in a case that could undermine label carveouts and slow the launch of generics is the topic of hallway chatter at this week’s annual conference of the Association for Accessible Medicines.
The process of reauthorizing critical U.S. FDA user fee agreements (UFAs) for drugs, generics and biosimilars took its first step forward in Congress Feb. 3 as the House Energy & Commerce Subcommittee on Health dipped its feet into the new enhancements included in the agreements the FDA negotiated with stakeholders over the past two years.
In keeping with its Drug Competition Action Plan released in 2017, the U.S. FDA finalized two guidances this week focused on the submission and review of generic drugs.
More than three years after tossing a controversial proposal to allow manufacturers of generic drugs to update their labeling independent of the reference list drug (RLD) and promises that it would take a more proactive role in identifying and facilitating labeling updates, the U.S. FDA issued a draft guidance Jan. 25 intended to help holders of abbreviated new drug applications (ANDAs) keep their labels up to date with that of the RLD.
Among the low-hanging fruit for pruning back U.S. drug prices is the development of generics referencing complex drugs, a category that includes drug-device combination products and nonbiologic drugs with a complex molecular base, route of administration or formulation, such as abuse-deterrent opioids.
The governor’s signature brought California a step closer to realizing state officials’ dream of having their own generic and biosimilar drug label. In signing the California Affordable Drug Manufacturing Act into law Sept. 28, Gov. Gavin Newsom touted the legislation as a way to break down market barriers to affordable prescription drug prices. “Our bill will help inject competition back into the generic drug marketplace – taking pricing power away from big pharmaceutical companies and returning it to consumers,” he said.
In March, when a district court ruled in favor of two ANDA filers in Amarin Corp. plc’s patent litigation case regarding its fish oil cardiovascular therapy franchise, Vascepa (icosapent ethyl), CEO John Thero said an appeal was a strong possibility.
Nearly 40 years on, the generic drug market is often lauded as an American success story. But a closer inspection reveals such back-patting ignores the potential for serious public health risks caused by ongoing shortages in the generic drug supply. It also ignores quality issues and lingering physician and patient doubts about generics, especially those made in other countries.
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