Drugs

Petition Seeks Gov’t Action to Allow Generic Semaglutide

Public Citizen is urging HHS to use its authority under 28 USC. § 1498 to permit generic competitors to manufacture Novo Nordisk’s semaglutide, the active ingredient in diabetes drug Ozempic and weight-loss drug Wegovy. In an 8/5 petition, the advocacy group argues that its request for the government to make the rare move under Section 1498 and disregard active patents on the drugs is necessary because Novo Nordisk’s “outrageous pricing of semaglutide threatens to break the coffers of federal health programs.” Under Public Cititzen’s proposal, authorized generic companies could produce semaglutide on behalf of the federal government so they can supply Medicare, Medicaid, and other federal health programs.

The group says Novo Nordisk charges Americans up to 15 times more for these drugs than citizens in Canada, Japan, or Europe. For example, it says Ozempic costs $155 in Canada and $59 in Germany, but the list price of Ozempic is $969 for a month’s supply in the U.S.

Under Sec. 1498, the U.S. government has the authority to make or purchase a patented invention without the permission of the patent holder in exchange for reasonable compensation, Public Citizen says. “When the government exercises its authority under § 1498, the patent holder may not seek injunctive relief, nor can a government contractor or subcontractor be held liable for infringement by the patent holder,” it explains. “In modern cases, reasonable compensation under § 1498 has consistently been determined to be a reasonable royalty payment and not lost profits.”

Public Citizen notes that the authority was exercised 59 times during the Covid-19 health emergency including against Moderna for expanded manufacturing of its Covid-19 vaccine, which generated tens of billions of dollars of revenues for the company.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome