Drugs

No Major Changes in ‘Intended Use’ Reg: Attorney

Attorney Bryan Feldhaus (DuVal & Associates) says his firm does not think the new FDA “intended use” rule published on 9/1/21 represents a material change for drug and device manufacturers in 2022. In this way, his analysis differs from some observers who have projected an increased exposure for drug and device manufacturers regarding off-label communications. Feldhaus cites three reasons for his conclusion:

the new intended use rule does not set out any new enforcement authority for FDA, instead simply codifying the agency’s prior approach to the evidence relevant to determining a product’s intended use;
the new rule limits enforcement based on mere knowledge of off-label use; and
FDA enforcement authority remains restricted by First Amendment protections.

“While there may be some initial growing pains associated with the amended Section 801.4, and even some expansion of FDA’s authority under the new provision,” Feldhaus concludes, “the amendments were intended to clarify, and not change, the definition of intended use….. Therefore, although there was a five-year delay in implementing the amended regulation, we do not believe the amendments to Section 801.4 will materially change off-label communications in 2022 or beyond.”

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

Read more

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