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# AbbVie Urges FDA to Ban Unlicensed Thyroid Products
- URL: https://www.fdaweb.com/abbvie-urges-fda-to-ban-unlicensed-thyroid-products/
- Published: 2024-04-05T12:00:00.000Z
- Updated: 2026-09-14T14:27:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156722

AbbVie has petitioned FDA urging it to crack down on newly introduced unlicensed desiccated thyroid extract (DTE) products. The company acknowledges that it makes Armour Thyroid (thyroid tablets, USP), an unlicensed DTE product that has been used in the U.S. since the early 1900s for treating hypothyroidism and other thyroid conditions.

AbbVie notes in the [petition](https://downloads.regulations.gov/FDA-2024-P-1715-0001/attachment%5F1.pdf?ref=fdaweb.com) that the agency has historically exercised enforcement discretion with respect to DTE marketed products. “Specifically, in a formal published compliance policy, FDA explained how it would permit commercialization of unapproved drugs based on risk-based priorities for enforcement action, while also encouraging companies to pursue scientific trials to get their products approved,” it says.

In 2010, DTE products were reclassified as biological products and subject to regulation under the Public Health Service Act’s BLA requirement, the company says. “Further, in late 2020, the compliance policy was withdrawn, although FDA has publicly stated since then that it would continue to use its existing risk-based approach to prioritizing regulatory and enforcement actions against unapproved new drugs.”

In turning to current activities, AbbVie says that after more than a decade with no new DTE product entrants, “multiple companies in 2023 and 2024 have launched into interstate commerce new (never before marketed) DTE products which lack licensure. These companies do not appear to be seeking licensure and their products are nevertheless promoted directly to patients as equivalent to other DTE products, sometimes as even superior to non-DTE products that FDA has approved to treat hypothyroidism and other thyroid conditions. Accordingly, FDA now faces a new direct challenge to its new product approval framework regarding the proliferation of unlicensed biological products.”

AbbVie says the agency must address this challenge as a matter of public health. “Manufacturing DTE products is a complex process, and finished DTE products have a narrow therapeutic range and a patient population requiring accurate dosing,” it says. “FDA oversight through the IND process is necessary to protect patients taking these medically necessary drugs until FDA licenses a DTE product. The agency balanced two goals with its compliance policy for unapproved new drugs: encouraging companies that had been marketing unapproved products (in many cases for decades) to perform the research needed to secure approval, on the one hand, while protecting the public health by removing products that are marketed in direct challenge to the regulatory framework, on the other hand — and achieving both goals without burdening patients or disrupting the market with unnecessary enforcement actions.”

The petition requests that FDA ban manufacturers who lack active INDs and mature clinical development programs from marketing unlicensed DTE products. It also requests that it stop DTE manufacturers from promoting and making false and misleading statements about their unlicensed products.