Drugs

FDA/Patent Office Coordination Bill Advances

A bill that would establish a task force between the U.S. Patent and Trademark Office (USPTO) and FDA to improve communication and coordination in implementing each agency’s activities related to drug patents has been advanced by voice vote in the Senate Judiciary Committee. The Interagency Patent Coordination and Improvement Act of 2022 (S.4430) was introduced last month by Sens. Dick Durbin (D-IL), chair of the Senate Judiciary Committee, ranking member Chuck Grassley (R-IA) and Thom Tillis (R-NC).

“Currently, there is very limited collaboration between USPTO and FDA, despite both agencies playing a role related to patents and competition,” the lawmakers said in an earlier release. “By incentivizing coordination, we can empower patent examiners and in turn boost competition, including for prescription drugs,” Durbin says. “Having access to accurate prior art is critical to ensure that the USPTO issues high-quality patents,” Tillis says. “By improving coordination between the USPTO and FDA, Congress can ensure that patent examiners have access to all of the relevant information that they need to help them make a sound determination regarding patentability.”

Specifically, the task force created by the legislation would:

enhance information sharing on each agency’s processes, standards and methods
improve dialog on new technologies and scientific trends
enable confidential reciprocal access to information, if requested and only as needed
ensure accurate representations by companies between the two agencies and ensure accuracy of patent listings.

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