Drugs

Bill Would Whittle Down Biologic Exclusivity

Congresswoman Jan Schakowsky (D-IL) and congressman Bruce Westerman (R-AR) have reintroduced the bipartisan Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act to make prescription drugs more affordable and accessible for Americans across the nation. The measure aims to “addresses one of Big Pharma’s most effective price gouging tools by reducing the exclusivity period for biologics from 12 years to five years," the lawmakers say in a 5/19 release.

“This Congress marks the second time that the legislation is bipartisan in the House of Representatives," Schakowsky noted, adding that she previously introduced the bicameral PRICED Act in 2010 with the late Senator John McCain (R-AZ).

In 2017, all of the top 10 highest-expenditure drugs in Medicare Part B were biologic products, totaling over $10 billion, Schakowsky said. Previously, the Office of Management and Budget estimated that reducing the exclusivity from 12 to seven years could save almost $7 billion over 10 years. “Reducing the exclusivity period to five years would save even more money and aligns biologics with the traditional period guaranteed under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) and with the exclusivity period for small-molecule drugs,” she said.

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