Exclusive — Coalition Urges FDA to Stop Sale of Counterfeit Weight Loss Drugs

A coalition of conservative, activist, and other groups on Tuesday urged Food and Drug Administration (FDA) Commissioner Dr. Marty Makary to stop the sale of counterfeit and unsafe weight loss drugs, Breitbart News has learned exclusively.

“We are grateful for your diligent enforcement of President Trump’s vision to bring as much pharmaceutical manufacturing as possible back to the United States — and to inspire the generation of innovative pharmaceutical research and development right here in America. The President’s recent deal with major pharmaceutical companies to bring back domestic drug
production was encouraging and bodes well for America’s future,” the coalition wrote to the leader of the FDA.

However, the group said, there is a “hazardous” trend that runs counter to President Donald Trump’s efforts to vision to bring pharmaceutical manufacturing to the United States — counterfeit drugs, particularly from Chinese manufacturers.

They warned that these counterfeit drugs are often sold through “direct-to-consumer” methods, without prescriptions, and are often “ineffective” or “affirmatively harmful.”

The coalition warned that Chinese manufacturers often abuse the FDA’s “greenlist” to be able to sell these counterfeit drugs:

We are particularly concerned that Chinese manufacturers are exploiting the FDA’s “greenlist” and related import-screening practices to move compounded GLP-1 products into the United States under the guise of regulatory compliance. By positioning themselves as greenlisted suppliers, these entities can more easily ship active ingredients and finished compounded dosage forms that are neither FDA-approved nor subject to the same rigorous oversight as drugs manufactured in the United States. This trend risks turning a mechanism intended to facilitate safe and efficient trade into a backdoor for unsafe, unvetted GLP-1 compounds that directly compete with and undercut lawful American manufacturers, while exposing U.S. patients to serious harm. [Emphasis added]

The coalition asked for the FDA to provide detailed responses to the FDA to their questions, which include:

• What is the timeline for FDA action to protect the supply of genuine American GLP-1 drugs and eliminate the supply of fake and harmful GLP-1 drugs?
• What are some examples of protective steps that the FDA could take or has already planned to take to reassure consumers and guard public health?
• With what federal, state, and private-sector partners does the FDA plan to collaborate on this effort?

Members of the coalition include:

• Saulius Anuzis, president of the American Association of Senior Citizens
• Hon. J. Kenneth Blackwell, president Council for National Policy
• Morton Blackwell, Virginia Republican National Committeeman
• Tony Perkins, Family Research Council
• Sal Russo, cofounder and chief strategist, Tea Party Express
• Tom Schatz, Citizens Against Government Waste (CAGW)
• Raul Lopez, board member, RX Border Defense

The letter to FDA Commissioner Makary follows as Breitbart News reported last August that a poll found that 92 percent of Trump voters want the FDA to do more to protect Americans from unsafe prescription drugs.

The survey, conducted by Fabrizio Ward, one of Trump’s favored polling firms, found that Trump voters remain highly concerned about the growing threat of unsafe, foreign-made ingredients entering the country through online pharmacies and compounders. Ward conducted the poll on behalf of Rx Border Defense.

“This isn’t just a public health issue, it’s a national security crisis,” Raul Lopez, a board member of Rx Border Defense, which commissioned the poll, said in a written statement to Breitbart News at the time. “When we allow foreign adversaries like China to flood our communities with unregulated, dangerous compounded drugs and ingredients, we’re not just risking lives, we’re funding violence, empowering domestic gangs, and undermining American safety. If we want secure borders and safe neighborhoods, we need to shut down the foreign drug pipeline and take back control.”

Federal and state officials, including 38 members of the National Association of Attorneys General and 80 members of Congress, such as Sens. Jim Banks (R-IN) and Marsha Blackburn (R-TN), have called on the FDA, Attorney General Pam Bondi, the Department of Homeland Security (DHS), and the Federal Trade Commission (FTC) to increase oversight over online sellers of compounded GLP-1 receptor antagonists and unregulated active pharmaceutical ingredients (APIs).

“The safety of American patients is under attack from unregulated foreign drug factories, shady online pharmacies, and unchecked compounders operating outside the law,” Lopez concluded in his statement. “Americans are sending a clear message: they want to stop the dangerous flow of counterfeit drugs, manufacture essential medications here at home, and hold violators accountable.”