Drugs

Bill Would Require HHS Drug Price Negotiations

Legislation introduced by four congressional Democrats would direct HHS to negotiate with drug manufacturers for lower prices on covered Medicare Part D drugs. Rep. Lloyd Doggett (D-TX), the bill’s prime sponsor, says drug pricing in the U.S. “is a tangled mess, a knot that will take more than one cut to pull apart. Harnessing the purchasing power of Medicare and negotiating better deals for drugs through a process similar to that already available for our veterans is a significant first cut at the knot….” He was joined by Sen. Bernie Sanders (I-VT) and Reps. Elijah Cummings (D-MD) and Peter Welch (D-VT).

Doggett also introduced two other bills to address prescription drug pricing. He says his Competitive Deals Resulting in Unleashed Generics and Savings (Competitive DRUGS) Act would crack down on so-called pay-for-delay deals, while the Transparent Drug Pricing Act would require drug manufacturers to disclose information that influences drug prices such as research and development costs, manufacturing and marketing costs, acquisitions, federal investments, and revenue and sales, to the HHS secretary.

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