Drugs

Authorize Generic GLP-1s: Public Citizen

Public Citizen is petitioning HHS to authorize generic competition for Novo Nordisk and Lilly’s GLP-1 weight-loss drugs. A Public Citizen statement says that generic forms of Novo Nordisk’s Wegovy, Ozempic, and Rybelsus (all semaglutide), and Lilly’s Mounjaro and Zepbound (all tirzepatide) are expected to begin selling in Canada this year for less than $100.

“In the United States,” the statement says, “Novo Nordisk’s and Eli Lilly’s exorbitant pricing on GLP-1s is limiting access for patients while having catastrophic effects on health program budgets. Novo Nordisk and Eli Lilly have repeatedly price-gouged the U.S. compared to other countries including Canada, Japan, and the UK., charging Americans up to 16 times as much for the same treatments.”

The advocacy group says that between 2020 and 2024, Medicare’s gross spending on the Novo Nordisk semaglutide products increased nearly ten-fold, reaching $15.16 billion in 2024, despite a prohibition on coverage for weight loss. It says that generic competition could save Medicare more than $8 billion for currently covered indications in the first two years, which Public Citizen says is over $3 billion more than the estimated savings that could be achieved through prices set as part of voluntary agreements between the Trump administration and the companies.

Public Citizen says that under existing law, the government has the power to overcome patent barriers at any time. “If Trump were serious about lowering drug prices,” it says, “he would challenge Novo and Lilly’s patent monopolies and not let Americans continue to pay the highest prices in the world.”

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

Read more

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