Drugs

Coordinate on Drug Patent Oversight: Senators

Sens. Bill Cassidy (R-LA) and Maggie Hassan (D-NH) say FDA and the Patent and Trademark Office (PTO) should close oversight gaps that they say delay generic drugs from coming to market and thus keep drug costs high. In a statement, the senators say a lack of coordination between the two agencies “has allowed the pharmaceutical industry to obtain patents of questionable validity. Through these patents, drug manufacturers are able to delay the entry of generic drugs and extend monopoly prices. We request information on the extent to which the PTO seeks, obtains, and considers FDA information when reviewing pharmaceutical-related patent applications.”

A letter to the two agencies quoted in the statement says that under the Federal Food, Drug, and Cosmetic Act, FDA is authorized to share information with the PTO. “However, the lines of communication between the agencies appear not to be working,” the senators write. “With better inter-agency coordination, many of these patent applications would have likely been denied.”

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