Senators Introduce Legislation to Combat Foreign Counterfeit Drugs

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Nov 12, 2025 - 11:32 Updated: Nov 11, 2025 - 20:07
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Senators Introduce Legislation to Combat Foreign Counterfeit Drugs

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Two Republican senators have introduced legislation aimed at cracking down on foreign counterfeit drugs, particularly those produced in China.

Sens. Tom Cotton (R-Ark.) and Pete Ricketts (R-Neb.) introduced the Combating Counterfeit Pharmaceuticals Act (S.3134).
The legislation would amend the Fentanyl Sanctions Act, requiring intelligence agencies to identify manufacturers and traffickers of counterfeit drugs and their ingredients and directing the Department of the Treasury to impose sanctions on those entities, according to a Nov. 7 statement from Cotton’s office.

“Dangerous and ineffective counterfeit drugs from Communist China and other adversarial nations pose an increasing threat to consumers. Our bill will crack down on all counterfeit drugs to ensure Arkansans have access to safe and effective medicine,” Cotton said in the statement.

In fiscal year 2024, pharmaceuticals ranked second behind handbags and wallets in the quantity of items seized for violating intellectual property rights, with more than 3.7 million items seized, according to a report from U.S. Customs and Border Protection (CBP). The total manufacturer’s suggested retail price of the seized pharmaceuticals was over $129 million.

Cotton is the chairman of the Select Committee on Intelligence. Ricketts serves on the Committee on Foreign Relations.

“Communist China’s drugmakers are quickly manufacturing and selling copy-cat drugs based on our biological advances,” Ricketts said in a statement. “By doing so, Communist China is pumping Americans full of unregulated, substandard ingredients. It is time to get these Chinese-made compounds out of our borders. Our efforts will target organizations engaged in illicit opioid trafficking posing fatal consequences here at home.”

To encourage generic drug companies to conduct testing and manufacturing in the United States, the U.S. Food and Drug Administration announced a new pilot program on Oct. 3 that offers faster regulatory reviews for companies meeting specific criteria. One such requirement is that the companies must use “exclusively domestic sources” for active pharmaceutical ingredients (APIs).

The FDA noted in the announcement that, as of 2025, only nine percent of API manufacturers are located in the United States, compared with 22 percent in China and 44 percent in India.

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Undated file photograph showing counterfeit M30 oxycodone pills. Courtesy of the U.S. Drug Enforcement Administration
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Bioequivalence testing for generic drugs is increasingly taking place outside of U.S. borders, the agency added, noting that such outsourcing is weakening the country’s pharmaceutical research and development infrastructure.

“Overreliance on foreign drug manufacturing and testing creates risks both to national security and patient access, and undermines investments in U.S. research, manufacturing and production,” Dr. George Tidmarsh, director of the FDA’s Center for Drug Evaluation and Research, said in a statement at the time. “This pilot prioritization program can help ensure that Americans have a strong and resilient domestic drug supply.”

Cotton also welcomed the FDA’s decision.

In an Oct. 3 post on X, the senator wrote, “Our country can’t continue to rely on medicine produced by our adversaries like Communist China.”
In September, the FDA announced the the creation of a “green list” import alert for GLP-1 APIs, noting that dangerous foreign counterfeits of GLP-1 drug ingredients are being used to make unapproved compound drugs targeting individuals seeking weight loss medication.

In August, Cincinnati CBP seized 54,843 unapproved medical products—including Botox and popular weight-loss medications—mostly originating from Hong Kong and China.

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