Drugs

FDA Says Proposed Drug Import Guidance ‘Unwarranted’

FDA has denied as unwarranted a 3/1/2024 petition submitted by Aimed Alliance asking that the agency issue a guidance with an interpretation and a clear position statement about drug importation activities conducted by alternative funding programs. Specifically, the petition said the proposed guidance should address:

whether third-party companies that partner with employer-sponsored health plans can legally require employees to import their prescription drugs from outside the U.S.; and
whether third-party companies that partner with employer-sponsored health plans can import prescription drugs on behalf of customers enrolled in an alternative funding program.

The petition also asked that the proposed guidance include “an explanation of the existing reporting pathways available for individuals and organizations to promptly notify FDA of instances where entities engage in such practices.”

The denial letter says FDA shares the concern about risks posed by unapproved new drugs and misbranded drugs. It notes all the information the agency makes available in various ways about human drug importation, and says that in light of that information, “it would not be an efficient use of FDA’s limited resources to issue the guidance proposed in the petition….”

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