Drugs

House Committee Advances 4 Drug Pricing Bills

The House Judiciary Committee has unanimously passed four bills to address prescription drug pricing. A committee media release says that marking up and advancing the four bills is part of the first phase of the committee’s agenda to lower the cost of prescription drugs. The bills are:

H.R. 2375, the Preserve Access to Affordable Generics and Biosimilars Act, would strengthen the Federal Trade Commission’s ability to challenge anticompetitive pay-for-delay agreements in court;
H.R. 965, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, would prohibit drug companies from engaging in anti-competitive conduct to prevent generic versions of prescription drugs from entering the marketplace;
H.R. 2374, the Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act, would curb abuse of the FDA citizen petition process and expand access to prescription drugs by reducing incentives for branded pharmaceutical companies to interfere with the regulatory approval of generics and biosimilars that competes with their own products; and
H.R. 2376, the Prescription Pricing for the People Act of 2019, would require the Federal Trade Commission to study the state of competition in the drug supply chain, focusing on whether pharmacy benefit managers have engaged in any anti-competitive practices.

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