Drugs

FDA, USPTO Outline Steps to Lower Drug Prices, Aid Competition

In a joint blog post, FDA commissioner Robert Califf and U.S. Patent and Trademark Office (USPTO) director Kathi Vidal discuss initiatives their two agencies are undertaking to execute the Biden administration’s agenda to lower drug prices and promote competition. “These initiatives will strengthen our relationship and expand the resources available for assessing patentability and addressing instances of patents being used improperly to delay competition,” Califf and Vidal write.

The post says that through the initiatives, the USPTO will protect against the patenting of incremental, obvious changes to existing drugs that do not qualify for patents. “This effort can lead to lower drug prices,” it says, “because drug companies will not be able to unjustifiably delay generic competition based on trivial changes to a drug product.”

The USPTO says it will work to ensure that patent examiners have the time and resources they need to conduct a thorough review of patent applications for pharmaceutical inventions. FDA will assist the USPTO in training patent examiners on the state of the art in pharmaceutical and biologic fields. The USPTO will provide new tools for patent examiners to search enormous and growing global databases of technical information, including publicly available sources maintained by FDA, to determine whether similar innovations already exist.

“Our intent is to ensure our government’s innovation system strikes the appropriate balance, encouraging meaningful innovation in drug development while not unduly delaying competition that provides relief from the high cost of medicines,” Califf and Vidal write.

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