Drugs

Bipartisan Bill to Codify Trump Drug Price Order

Four House members have introduced the Global Fairness in Drug Pricing Act to codify major portions of President Trump’s executive order on drug pricing. The legislation was introduced by Reps. Ro Khanna (D-CA), Anna Paulina Luna (R-FL), Marcy Kaptur (D-OH), and Andy Biggs (R-AZ).

A statement issued by Khanna says, “Americans pay the highest prescription drug prices in the world, in some cases up to 10 times more than patients in other comparably developed nations for the same exact medications. President Trump’s executive order, while a step forward, could be tied up in the courts and delayed indefinitely, without action from Congress.”

The statement says the bill would:

direct HHS to propose rulemaking that imposes “most-favored-nation” price targets, aligning U.S. drug prices with those in peer countries; and
authorize FDA to consistently grant importation waivers for prescription drugs from countries with strong safety records and lower costs.

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