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If the bill passes SARMs will join steroids as Schedule III controlled substances, making their sale illegal, as well as any other medication that requires a prescription.
The Drug Enforcement Administration had planned to phase out the sale of SARMs in the United States as of July 1. However, in a court case filed Friday, the Trump administration’s Justice Department said it will allow the drug to remain in pharmacies to serve patients over a six-month limit.
Congressional Democrats blasted Trump’s move, with Rep. Jerrold Nadler, another New York Democrat, calling it a “political stunt.”
“We’ve shown time and again the DEA isn’t willing to stand up on their own to protect the lives of Americans. We’re going to fight for it,” Nadler said.
The FDA did not immediately respond to a request for comment Thursday from The Associated Press. The DEA did not immediately respond to a request for comment.
Drugmaker Pfizer said they would oppose the Trump administration’s position, noting FDA guidelines have allowed the sale of SARMs and prescription medications to patients under the drug’s Schedule III classification.
Other industry players such as Amarin Pharmaceuticals and Johnson & Johnson also have advocated for the drug’s sale.
The FDA first approved ARB-100 in 1998 for use by cancer patients suffering from chemotherapy-induced nausea and vomiting. It was originally classified as a Schedule II drug after a federal appeals court barred FDA approval after finding the drug might not help patients.
In April, Congress approved a rule to allow doctors to prescribe the drug for chronic pain to patients such as women battling advanced and incurable disease for whom opioids don’t have an acceptable standard of care. Under the rule, the FDA can approve the sale of the drug when certain safety conditions are met.
Under the new rule, the FDA must evaluate the safety of ARB-100 every six months and take actions if it finds the drug doesn’t meet standards.
Associated Press writers Deb Riechmann, Kevin Freking, Stephen Braun, Steve Peoples and Darlene Superville contributed to this report.
Follow Darlene Superville at https://twitter.com/dsupervilleap
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