Drugs

WLF Wants Ban on Drug Prices in Ads

Washington Legal Foundation (WLF) is urging the U.S. Court of Appeals for the DC Circuit to affirm a decision blocking an HHS rule that would require drug makers to include the wholesale acquisition cost (defined by HHS as the “list price”) of any drug advertised in direct-to-consumer (DTC) TV ads. WLF’s amicus brief was joined by the Allied Educational Foundation.

In a statement, WLF says the HHS rule is being promoted as part of the Trump administration’s effort to reduce overall healthcare costs. “No matter how well-meaning its intentions,” WLF says, “HHS may exercise only the limited regulatory authority that Congress granted it by statute. Yet no statute authorizes the Centers for Medicare and Medicaid Services to require disclosure of list prices in DTC television ads.”

The brief says the lack of statutory authority is not the only fatal flaw in the proposed rule. It says the list price disclosure would also violate drug makers’ First Amendment rights by compelling them to speak a particular message in their ads. “Under Supreme Court precedent,” the brief says, “HHS’ controversial DTC rule violates the First Amendment because it misleads consumers about their likely out-of-pocket costs for prescription drugs

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