Devices

Medical Device Tax Repealed

Congress gave Christmas presents to medical device manufacturers and other healthcare sector interests with provisions included in the $1.4 trillion spending bill approved before the holidays. The Washington Post reports that the pharmaceutical industry won extended protections for certain patents, even as Congress refused to act on a Senate bill to address rising drug costs. Also in the bill was the repeal of several Affordable Care Act provisions, including the tax on medical device manufacturers.

According to the Post analysis, medical device lobbyists held one-on-one meetings with lawmakers, including freshman Democrats from districts President Donald Trump won in 2016. They also encouraged governors to send letters to Congress and told lawmakers personal stories from patient support groups. “As we made the case to members of Congress, people began to agree it’s just not good policy,” AdvaMed CEO Scott Whitaker told the newspaper.

Some 17 words added to page 1,503 of the spending bill deems “chemically synthesized polypeptides” to be biologics, and thus eligible for 12 years of market exclusivity, seven more years than they would receive if they were treated as small molecule drugs.

Congress declined to include an effort to lower prescription drug prices. Sen. Chuck Grassley (R-IA), who co-sponsored legislation to cap drug price increases in Medicare with Sen. Ron Wyden (D-OR), blamed Senate majority leader Mitch McConnell (R-KY) for not including the bill in the spending legislation. Although the White House reportedly backed the legislation, McConnell said he wouldn’t take it up because it was not supported by a majority of Republicans

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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’

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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

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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