Treatment for millions of Americans at stake in ‘skinny label’ Supreme Court case
The Supreme Court is set to rule on a case that could significantly impact the balance between generic drug availability and pharmaceutical innovation. The case, Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., revolves around the 'skinny label' provision of the Hatch-Waxman Act. A ruling against the generic manufacturer could hinder research incentives for new uses of existing FDA-approved drugs.
- ▪The case could affect the launch of generic drugs and the financial savings they provide to patients and taxpayers.
- ▪The 'skinny label' allows generic drugs to be marketed for FDA-approved uses that are no longer patent-protected.
- ▪The ruling may determine if generic companies can be liable for patent infringement when marketing drugs for off-label uses.
Opening excerpt (first ~120 words) tap to expand
The Supreme Court will soon decide a case that could upend the balance built into a bipartisan law that has accelerated the launch of generic drugs and saved American patients, employers, and taxpayers trillions of dollars in recent decades — while still incentivizing biopharmaceutical companies to research and develop medicines in the first place. The stakes of the case, Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., extend well beyond the two companies involved. The ruling could have a dramatic effect on incentives to invest in researching additional uses for FDA‑approved medicines. Recommended Stories California teachers union shortchanges students with left-wing activism AFT members paid for Weingarten’s book.
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Excerpt limited to ~120 words for fair-use compliance. The full article is at Washington Examiner.
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