Drugs

FDA Facing Backlog of ODE Determinations: Attorneys

With FDA remaining silent on orphan drug exclusivities for products approved after the 2021 11th Circuit Court of Appeals decision in Catalyst Pharmaceuticals v. Becerra, there is a backlog of exclusivity decisions awaiting FDA action. That’s the report of attorneys Jacqueline Berman and Nikita Bhojani (Morgan Lewis) writing in an online blog post.

In a 1/24 notice to clarify drug exclusivity, FDA said it will continue to apply its orphan drug regulations so that exclusivity’s scope is tied to the specific orphan indication for which a drug is approved and not the indication for which the drug was designated.

The attorneys say it is unclear whether the agency intends to go back to address the gap in exclusivity determinations or whether it will only make determinations on an as-needed basis such as when a second product sponsor submits a marketing application.

“Sponsors who either have received approvals without exclusivity determinations or sponsors who have a need for information regarding the scope of existing exclusivities may want to consider formally requesting a decision by FDA,” the authors suggest. “Given the split between FDA’s and the court’s interpretation of the Federal Food, Drug, and Cosmetic Act, absent congressional action, it is likely a company whose exclusivity is drawn more narrowly to the approved indication may challenge the decision.”

The attorneys say that companies may reconsider strategies for requesting designations, going with as broad a designation as can be substantiated in the event of another challenge and court decision adopting the rationale in Catalyst.

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