Drugs

HHS Advancing DTC Pricing Disclosure Rulemaking

HHS’s Centers for Medicare & Medicaid Services (CMS) has submitted to OMB for review 3/18 a proposed rule to require including drugs’ list prices in direct-to-consumer (DTC) advertising. The OMB submission was briefly announced by HHS secretary Alex Azar during a speech to the American Health Lawyers Association about lowering drug prices 3/18.

The proposed ruled was released for comments 10/2018. Comments submitted by the Washington Legal Foundation (WLF) called on CMS to withdraw its proposed rule, saying that CMS can only exercise the limited regulatory authority granted to it in laws approved by Congress. There is no law that authorizes CMS to require disclosure of list prices in DTC television ads, it says. The comment also says that the proposal would violate the drug makers’ First Amendment right to speak truthfully about their products. “The First Amendment protects a speaker’s choices about both what to say and what not to say,” WLF declared. “And by compelling drug makers to speak a particular message in their DTC ads, the proposed rule seeks to alter the content of their speech.”

Meanwhile, Johnson & Johnson pharmaceutical group Janssen recently said it was taking the lead to begin including list price information in DTC TV ads. Beginning this quarter, the company said pricing disclosures will begin with its oral anti-coagulant Xarelto, and the advertising will include both the list price and potential patient out-of-pocket costs. The company’s decision to disclose the pricing comes in reaction to the Trump Administration’s American Patients First Blueprint issued 5/2018 that proposed requiring the pricing information in DTC ads. “We saw an opportunity to envision – and implement – additional transparency that would enable patients to make more informed decisions,” said Janssen group chairman Scott White in a company release.

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