Drugs

Buyers’ Group Wants Generic Drug Legislation

Healthcare Supply Chain Association president Todd Ebert says that the backlog of generic drug applications at FDA is contributing to the problem of drug price increases. Writing in a letter to the New York Times, Ebert says that his association supports legislation (S. 2615, the Increasing Competition in Pharmaceuticals Act) introduced by Sens. Susan Collins (R-ME) and Claire McKaskill (D-MO) that would require FDA to give priority review to any drug application for a product with only one manufacturer.

“Price increases occur when there are two or fewer manufacturers of a generic drug,” Ebert writes, “and where limited competition among manufacturers has allowed high prices to go largely unchecked.” He says that since GDUFA was negotiated in 2011, the agency’s application backlog and median review time for product approval have continually risen, to an estimated 42 months in 2014 from 31 months in 2011. “A three- or four-year wait time stifles the ability of manufacturers who want to reintroduce competition to the generic market,” he writes.

Ebert says that as future opportunities arise to enhance the legislation, Congress should also consider mandating priority review for generic injectable drugs with two or fewer manufacturers.

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