Drugs

Sanders Wants ‘Fair Pricing’ on Taxpayer-Funded Drugs

Sen. Bernie Sanders (I-VT) and Rep. Peter DeFazio (D-OR) are proposing to amend the Federal Food, Drug, and Cosmetic Act with a rule requiring federal agencies and federally funded nonprofits to secure reasonable pricing agreements from drug manufacturers before they grant the manufacturers exclusive rights to make drugs, vaccines, or other healthcare products. In a statement (contains link to amendment text), Sanders cites a current situation in which Sanofi Pasteur has refused to agree to fair pricing on a Zika vaccine developed with more than $1 billion in taxpayer dollars.

Sanders says the U.S. Army is offering the company an exclusive license to develop and market the vaccine. He says that taxpayers have already spent more than $1 billion on Zika research and prevention efforts, including millions to develop a vaccine. HHS gave Sanofi $43 million to develop the vaccine, Sanders says, with $130 million in federal funding still to come. However, he says, the company has refused to sell the drug back to Americans at a fair price.

“Americans should not be forced to pay the highest prices in the world for a vaccine we spent more than $1 billion to help develop,” Sanders says. “Sanofi gets more than one-third of its roughly $34 billion in revenues from the United States alone, and its CEO made nearly $5 million in salary last year. Yet they have rejected the U.S. Army’s request for fair pricing. That is simply unacceptable.”

The statement says that as many as one-third of studies undertaken with drug and other healthcare companies to bring drugs to market are funded by American taxpayer dollars. However, there currently are no assurance that final products made available to the public will be priced affordably.

Sanders says that he and DeFazio first introduced their proposal decades ago with bipartisan support.

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