Dozens of legislators are making use of US health regulators to repress the market in strong expansion for drugs for weight loss with direct elimination in the middle of the growing concerns for their potential safety risks.On Friday, a group of over 80 Bipartisan legislators asked the Us Food and Drug Administration to stop the counterfeit and copied versions of GLP-1 drugs such as Wegovy and Zepbound to flood the market, a problem that emerged in the last year.
“We are concerned about the recent relationships that reveal an increase in illegal and counterfeit anti-obesity drugs,” they wrote in a letter to the commissioner of the FDA Marty Makary. “Undoubtedly, illegal counterfeit drugs represent an increased risk for patient safety with sometimes fatal consequences.”
The group-stage group on stage by the North Carolina Richard Hudson representatives and with the New Jersey herbs-convinced the agency to increase the application of drugs for weight loss I illegally imported. They suggested to issue warning letters and better monitor non -compliant online retailers and the so -called composed pharmacies that sell medicines.Legislators have also said that the FDA should work in tandem with the US customs and frontier patrol agents to prevent Chinese entities from sending drugs that are unancial weight in the United States. They requested an update on the efforts of the FDA by 30 July, given the “urgency” of the situation.
A spokesman for the FDA said that the Agency will work with the United States Health and Human Services Department to provide a “complete and complete” answer to the issues raised in the letter of legislators.
“Every effort to undermine the American offer of safe medicines is a problem that the FDA takes seriously,” said the spokesperson. “And we are deeply committed to strengthening the supervision of the products imported into the US entrance ports.”
In recent years, the popularity of GLP-1 drugs has led to an explosion of copycats and counterfeits made by companies that try to capitalize with clamor.
State pharmacies have been temporarily authorized to make copies of drugs during a lack of supply, but they are no longer authorized to do it after Novo Nordisk and Eli Lilly have increased production. However, some pharmacies refused to liquidate their operations while others rotated to sell drugs at lower doses in order to avoid regulatory control.
Contaellor drugs are made by unregistered entities in general using illegally imported ingredients.
Recently April, there are cases in which the counterfeit Ozimpic pens secretly enter the non -detected drug supply chain. Some patients are also purchasing ingredients directly from online sellers in an attempt to build the drugs themselves at home.
In both cases, the drugs do not pass through the same rigorous process of approval of the brand drugs made by Novo and Lilly. Experts fear that the lack of supervision is putting patients at risk.
The FDA claimed to be aware of the hospitalizations potentially linked to copying drugs, but that adverse events are probably underestimated.
“We support the bi-partisan request for the FDA to repress drugs counterfeit and illegally sold for weight loss,” said a spokesman for Hims & Hele Health, one of the telemedicine companies that sells composed GLP-1. “We appreciate the recognition of legislators according to which the legitimate compound drugs dispensed by the pharmacies regulated by the state are not counterfeit. Patients’ safety must always come before.”
Novo and Lilly have discouraged consumers from the use of composed and counterfeit products, including the telemedicine companies of Citati who sell the versions of Copycat and work with border agents to seize illegal shipments.
