Drugs

‘Intended Use’ Reg Needn’t Curb Production: Attorneys

Two Dechert attorneys say the 9/2021 FDA “intended use” regulation should not keep companies from manufacturing more of a drug or medical device than they would need to meet the anticipated demand for on-label prescriptions because it was aware of off-label uses. Writing in a Washington Legal Foundation Legal Opinion Letter, the two give three reasons why that sort of market analysis should not violate the regulation.

First, they write, any FDA inquiry into whether a company intended for its product to be used off-label must look beyond mere knowledge or awareness of off-label use to determine the company’s “objective intent” concerning product labeling.

Second, based on agency comments on the amended intended use regulation and court cases applying earlier versions of the regulation, merely manufacturing product to meet the demand for off-label use should not trigger an intended use finding.

Third, FDA’s lack of historical enforcement activities against companies accounting for off-label use in setting drug or device production levels, and its repeated observation throughout the final rule that the amendment to the regulation does not represent a change in FDA policy and practice suggests that this is not the type of business activity that the agency intends to regulate through the rule.

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