Drugs

House Dems Bill on Reducing Biologic Exclusivity

U.S. Representatives Jan Schakowsky (D-IL), Rosa DeLauro (D-CT) , Angie Craig (D-MN), Lloyd Doggett (D-TX), Raja Krishnamoorthi (D-IL), and Andy Levin (D-MI) have introduced HR 3379, the Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act, that would reduce the exclusivity period for biologics from 12 years to five years.

“Big Pharma has told us again and again that biologics are especially costly to develop and manufacture because of time and complexity,” Schakowsky said in a release. “They have demanded unique protections to supposedly recoup their investments. But we know that those claims are just another price gouging tool that have resulted in billions upon billions of profits as Americans struggle to afford drugs they need to survive.”

Schakowsky has been selected to co-lead the medicines negotiations of the House Democrats’ Trade Working Group as part of its review of the United States-Mexico-Canada Agreement (USMCA). “The USMCA as it stands now would keep drug prices out of reach for patients by locking in 10 years of marketing exclusivity for biologics,” she said. “If ratified, that language would stand in the way of Congress’ ability to pass bills like my PRICED Act, which would increase competition and enhance patient access to more affordable prescription drugs.”

The lawmakers noted that many recent peer-reviewed studies suggest that biologics are not as time-consuming to develop as initially believed. For example, a recent study in Nature concluded “although biologics are often thought to be more time-consuming to develop than small-molecule drugs, development times for biologics are similar to, or possibly somewhat shorter than, for small-molecule drugs.”

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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