Drugs

3-Year New Clinical Investigation Exclusivity Guidance Explained

Two Morgan Lewis attorneys say that while a new FDA draft guidance on three-year new clinical investigation exclusivity “does not break much new ground, it nonetheless serves as a helpful resource for applicants of NDAs seeking the exclusivity as well as applicants of follow-on applications potentially impacted by the grant.” Writing in an online post, the attorneys say the draft provides FDA’s most detailed explanation to date of how the agency interprets and applies the statutory requirements for the grant of this exclusivity under the Hatch-Waxman provisions of the Federal Food, Drug, and Cosmetic Act, as well as procedural expectations for submitting exclusivity requests.

In practice, the attorneys say, the three-year exclusivity most commonly arises in connection with approved changes to previously approved drugs, such as new indications, dosing regimens, routes of administration, formulations, or other clinically supported modifications. The post discusses these key elements of the draft guidance:

what constitutes a “clinical investigation”;
what makes a clinical investigation “new”;
the products that are studied in an exclusivity-qualifying investigation;
when an investigation is “essential to approval”;
novel trial designs;
how applicants should demonstrate they conducted or sponsored investigations; and
the procedural expectations for exclusivity requests.

“For drug sponsors,” the post concludes, “while the draft guidance provides greater transparency regarding how FDA evaluates requests for three-year exclusivity and what information applicants should provide when seeking exclusivity, FDA’s assessment of three-year exclusivity will likely remain a nuanced exercise that continues to raise new and novel issues for consideration. And because the draft guidance does not address the scope of exclusivity protection, companies will likely continue to rely on case-specific FDA decisions, citizen petition outcomes, and litigation to make a more complete assessment for three-year exclusivity in any given context. Submissions of requests for three-year exclusivity should be constructed and considered with care, with plans for three-year exclusivity ideally established in connection with applicable clinical trial design, to ensure that the resulting clinical investigations are properly recognized.”

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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