Drugs

Senators Ask Trump to Support ‘Pay-for-delay’ Bill

U.S. Sens. Chuck Grassley (R-IA) and Amy Klobuchar (D-MN) have sent a letter to the President urging him to support legislation to limit anticompetitive “pay-for-delay” pharmaceutical settlements between brand and generic drug makers as part of the Administration’s effort to bring down prescription drug prices. The letter, which was also sent to FDA and HHS, called on the Administration to specifically support their bipartisan Preserve Access to Affordable Generics Act that would help limit anticompetitive “pay for delay” settlement agreements that can delay generic drugs for years.

Their measure is intended to enhance competition in the pharmaceutical market by stopping anticompetitive agreements between brand name and generic drug manufacturers that limit, delay, or otherwise prevent competition from generic drugs. It would also prohibit anticompetitive practices in the pharmaceutical industry that harm consumers.

“We have long been concerned with the rising cost of prescription drugs and the strain it places on patients and our healthcare system, including critical government programs like Medicare and Medicaid. Noncompetitive drug markets can result in higher prices and reduced patient access to essential medical treatments,” the senators wrote.

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