Drugs

Bill to Update FDA Drug Preclusion Rules

Rep. Diana Harshbarger (R-TN) has introduced the Dietary Supplement Innovation Act that she says would modernize FDA’s drug preclusion provision to establish regulatory certainty, ensure pharmaceutical innovation, and support consumer access to dietary supplements. In a statement (includes a link to the bill text and to a brief description), Harshberger says ambiguous FDA standards can leave manufacturers without guidance and consumers guessing about which products are available.

“For decades,” she says, “this broken drug preclusion process has allowed Washington bureaucrats to threaten lawful dietary supplements that have safely been purchased over the counter for years, stifling innovation and denying Americans access to products they already trust. My bill delivers the regulatory certainty manufacturers need to innovate and invest with confidence, while establishing transparency and predictability within the drug preclusion framework and preserving consumer access to dietary supplements.”

She says the bill specifically would:

protect grandfathered ingredients that were marketed in food or dietary supplements before relevant drug approval or clinical
end perpetual preclusion by allowing it to expire when Phase 2 or 3 clinical investigations have been inactive or withdrawn for at least seven years or when drug development has been publicly discontinued;
create FDA exception authority to approve the use of an otherwise precluded drug or biological product in food or dietary supplements through an administrative order;
establish science-based standards that consider differences in administration, dosage, concentration or composition, and safety when determining whether a drug and dietary supplement contain the same “article”; and
provide immediate judicial review of FDA Warnings and other statements asserting a violation of drug preclusion, placing the burden of proof on the federal government.

Harshberger’s statement includes expressions of support for the legislation from the Council for Responsible Nutrition, the Consumer Healthcare Products Association, and the American Herbal Products Association.

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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