Drugs

Court Hits FDA Discretion in Drug/Device Decisions

The DC Circuit Court of Appeals has affirmed in a 4/16 decision a district court decision that FDA is not afforded discretion when a combination product meets the definition of both a device and a drug.

At issue in Genus Medical Technologies v. FDA was that having a product regulated as a device instead of a drug costs significantly less and subjects the company to less rigorous marketing authorizations, which the appeals court acknowledged in its ruling. More specifically, according to the court, Genus maintained that before and after it started producing its contrast agent Vanilla SilQ, it sought FDA 510(k) clearance to distribute its products as devices. In 2017, FDA issued a Warning Letter notifying the company that its products were “drugs” within the meaning of the Act.

The company disputed the Warning Letter’s findings and both parties were at an impasse after the agency’s Office of Combination Products ruled that the products meet the definition of a drug and also appear to meet the definition of a device. “In short, the agency reasoned that it must regulate contrast agents — which all meet the definition of drugs, but not necessarily devices — uniformly,” the lower court said.

Hyman, Phelps & McNamara, which represented Genus in the case, said the appeals court ruling is a “big win” for industry. “This decision limits FDA’s typically broad discretion and precludes the agency from imposing significant regulatory hurdles and costs based on policy positions rather than the congressionally imposed risk-based regulatory scheme,” it said. “In other words, FDA cannot regulate a device as a drug on a whim.”

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