Drugs

Law Settles ‘Active Ingredient’ Debate

A Congressional Research Service paper says Congress adopted 4/23/2021 legislation that generally codified FDA’s long-standing approach to evaluating new chemical entity (NCE) exclusivity. The paper, Defining Active Ingredient: The U.S. Food and Drug Administration’s Legal Interpretation of Regulatory Exclusivities, reviews the history of the debate between FDA and the pharmaceutical industry over the definition of “active ingredient” and the application of the definition.

Historically,” the paper says, “for the exclusivity provisions, FDA interpreted ‘active ingredient’ to mean ‘active moiety,’ as defined by FDA regulations. FDA generally defines active moiety as the core molecule or ion of a drug…. FDA’s interpretation generated disputes between FDA and pharmaceutical companies as FDA’s approach tends to exclude some drugs from being afforded five-year NCE exclusivity under the Federal Food, Drug, and Cosmetic Act (FFDCA). In 2015, a federal district court rejected FDA’s interpretation as inconsistent with the statutory language, though it did not explicitly invalidate FDA’s regulations.”

Two years later, the paper says, Congress enacted legislation that generally codified FDA’s long-standing approach to evaluating NCE exclusivity and extended that approach to certain other provisions under the FFDCA. “This legislation effectively mooted questions about the validity of FDA’s interpretation and clarified when chemical entities are sufficiently similar to be considered identical for purposes of drug approval and exclusivity,” the report concludes…. “In effect, the law committed the decision as to which molecules should be deemed effectively the same and therefore not innovative enough to merit NCE exclusivity to FDA’s judgment.”

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