Drugs

Follow Law’s Intent on Drug Innovation: Scott, Carter

Sen. Tim Scott (R-SC) and Rep. Earl Carter (R-GA) say they are concerned that a recent FDA draft guidance on advanced manufacturing technologies does not meet Congress’ intent expressed in provisions of their Manufacturing API, Drugs, and Excipients (MADE) in America Act. The guidance implements provisions in the FDA Omnibus Reform Act of 2023 that Scott and Carter say were based on the legislation they introduced in recent congresses. In a 3/1 letter to FDA commissioner Robert Califf, the lawmakers say, “Advanced manufacturing technologies (AMT) have the potential to prevent drug shortages, lower drug manufacturing costs, and improve drug quality. Currently, FDA only reviews manufacturing technologies with binding feedback to product sponsors during the review of a drug or biologic application. This paradigm disincentivizes AMT adoption in new products because it presents additional risk in the development process and in approved products because sponsors need to invest in the infrastructure to manufacture the product in a new way before ever getting binding feedback from the agency.”

The letter’s three concerns are that FDA:

has tied the AMT program to CDER’s Emerging Technology Team and CBER’s Advanced Technologies Team for both the qualification criteria and the logistical steps to enter the program;
has gone beyond the law’s scope by inserting the concept of designation “lifecycle” into the guidance; and
has unduly narrowed the provision contradictory to the statute by excluding BLAs such as those for gene and cell therapies, from cross-referencing AMT data from drug master files.

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