Drugs

Legal Update Highlights FDA’s Guide on 3 Year Exclusivity

A legal update from Wilson Sonsini Goodrich & Rosati (WSGR) addresses FDA’s release earlier this month of a draft guidance (see story) clarifying the scope and eligibility criteria for new clinical investigation exclusivity (3-year exclusivity) under the Federal Food, Drug, and Cosmetic Act. The draft guidance provides detailed criteria for qualifying as a “new clinical investigation” essential to approval, including studies conducted or sponsored by the applicant.

Among other evidence, applicants need to show they have “conducted or sponsored” the new clinical investigation in order to qualify for the exclusivity. “To this end,” the update says, “applicants can provide documentation showing that it has either 1) taken over, merged with, or purchased the predecessor entity, or 2) purchased all rights to the drug asset from another entity or acquired exclusive rights to the study. The FDA notes that purchase of nonexclusive rights to a clinical investigation after it is completed is not sufficient to qualify for the three-year exclusivity.”

The draft guidance also addresses when studies involving new cohorts or treatment arms may qualify for exclusivity, according to the update. It says such studies may be eligible if:

The cohort or arm constitutes a distinct clinical investigation
FDA has not previously relied on those specific results
The findings do not duplicate prior evidence used for approval

FDA also underscores that qualifying studies must measure clinical safety or effectiveness outcomes. Trials limited to pharmacokinetics, pharmacodynamics, or bioequivalence alone generally do not qualify, though studies combining these measures with clinical endpoints may be eligible, the update notes.

Additionally, the agency says it will continue using a case-by-case, multifactorial approach to encourage sponsors to submit results from distinct cohorts or treatment arms as they become available, rather than delaying submissions to bundle broader claims.

The draft guidance is open for public comment and may be updated with additional questions and answers over time. It also includes a template to help applicants formally request three-year exclusivity as part of their submissions.

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