Drugs

Bill to Restrict REMS from Delaying Competition

U.S. Senators Maggie Hassan (D-NH) and Mike Braun (R-IN) have reintroduced their bipartisan bill to close a loophole that pharmaceutical companies can exploit to block drug competition, including generic drugs. The bill would restrict drug companies from patenting their Risk Evaluation and Mitigation Strategy (REMS) programs to delay competition, according to the lawmakers.

“Some pharmaceutical companies patent their REMS program as a way to delay or block alternate versions of the medication from entering the market, in order to stop competition and keep prices high,” they say in a news release. “As detailed in the recent New York Times report, Jazz Pharmaceuticals used this exact strategy of patenting their REMS program in order to slow down the release of a similar drug from their competitor that is easier for patients to take.”

The bill would permit FDA to immediately approve drugs – instead of the normal 30-month approval stay – if the only barrier to approval is a REMS patent, Hassan and Braun say. Additionally, they say their bill stops pharmaceutical companies from abusing the patent and court system by ensuring that if a drug company sues to stop a generic over a REMS patent, the lawsuit may proceed, but it should not block a generic from being marketed.

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