Thyroid Slim-Down Drugs Spark Epic Trade Violation Showdown
Published Date: 2/19/2025
Notice
Summary
The U.S. International Trade Commission is reviewing a decision that found a company violated trade rules involving special thyroid medicine ingredients. This affects Viking Therapeutics and others making or selling these products in the U.S. The Commission is now asking for input on how to fix the problem, protect the public, and handle money matters, with deadlines coming soon.
Analyzed Economic Effects
6 provisions identified: 1 benefits, 4 costs, 1 mixed.
Imported accused drugs could be barred
The presiding judge recommended a seven-year limited exclusion order that could bar certain selective thyroid hormone receptor‑beta agonists and related products from entry into the United States. The statute authorizes the Commission to issue an exclusion order that would prevent the subject articles from being imported into the U.S.
Respondents may be ordered to stop U.S. sales
The recommended determination would also issue cease and desist orders requiring each respondent to stop engaging in unfair acts in the importation and sale of the accused articles in the United States. Cease and desist orders could prevent respondents from selling the accused products in the U.S.
100% bond could be required during review
The ALJ recommended imposing a 100 percent bond against accused articles imported during the period of Presidential review. If a remedy is ordered and the U.S. Trade Representative takes up to 60 days to act, the subject articles may enter the U.S. only under bond in an amount determined by the Commission (the ALJ recommended 100%).
Sanctions imposed on respondents and counsel
The final initial determination grants Viking's motion for sanctions under Commission Rule 210.33 and imposes certain non‑monetary and monetary sanctions against Respondents and/or their former counsel, Rimon PC, jointly and severally.
Possible clinical‑trial import exemption considered
The Commission specifically requested briefing on whether importation of accused products should be permitted for ongoing or planned clinical trials and asked parties to propose specific language and scope/duration if such an exemption is appropriate (citing 35 U.S.C. 271(e)(1)).
Public interest review focused on NASH impacts
The Commission will consider statutory public interest factors—public health and welfare, U.S. competitive conditions, U.S. production of like articles, and U.S. consumers—and requested detailed information about non‑alcoholic steatohepatitis (NASH), the effectiveness and availability of resmetirom, the likely effectiveness and overlap of Viking's VK2809 and Ascletis's ASC41/ASC43F, and the impact of exclusion on clinical trial enrollment over the next seven years.
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