(Bloomberg) — Dozens of lawmakers are urging US well being regulators to crack down on the booming marketplace for knockoff weight-loss medication amid mounting issues over their potential security dangers.
On Friday, a gaggle of greater than 80 bipartisan lawmakers requested the US Meals and Drug Administration to cease counterfeit and copycat variations of GLP-1 medication like Wegovy and Zepbound from flooding the market — an issue that emerged during the last 12 months.
“We’re involved about current studies revealing a surge in unlawful and counterfeit anti-obesity drugs,” they wrote in a letter to FDA Commissioner Marty Makary. “Undoubtedly, unlawful counterfeit drugs pose an elevated danger to affected person security with generally deadly penalties.”
The group — spearheaded by Representatives Richard Hudson of North Carolina and Herb Conaway of New Jersey — requested the company to ramp up enforcement over illegally imported weight-loss medication. They urged issuing warning letters and higher monitoring non-compliant on-line retailers and so-called compounding pharmacies that promote the medicines.
The lawmakers additionally mentioned the FDA ought to work in tandem with US Customs and Border Patrol brokers to cease Chinese language entities from delivery unsafe weight-loss medication into the US. They requested an replace on the FDA’s efforts by July 30, given the “urgency” of the scenario.
A spokesperson for the FDA mentioned the company will work with the US Division of Well being and Human Providers to supply a “full and thorough” response to the problems raised within the lawmakers’ letter.
“Any effort to undermine America’s provide of protected medicines is a matter that FDA takes severely,” the spokesperson mentioned. “And we’re deeply dedicated to strengthening the oversight of imported merchandise at US ports of entry.”
In recent times, the recognition of GLP-1 medication has led to an explosion of copycats and counterfeits made by firms in search of to capitalize on the hype.
State-licensed pharmacies have been briefly allowed to make copies of the medication throughout a provide scarcity, however are now not permitted to take action after Novo Nordisk A/S and Eli Lilly & Co. boosted manufacturing. Nonetheless, some pharmacies have refused to wind down their operations whereas others have pivoted to promoting the medication in decrease doses with the intention to keep away from regulatory scrutiny.
Counterfeit medication are made by unregistered entities usually utilizing illegally imported elements. As lately as April, there proceed to be cases when counterfeit Ozempic pens covertly enter the drug provide chain undetected. Some sufferers are additionally buying elements straight from on-line sellers in an try to make the medication themselves at house.
In each instances, the drugs don’t undergo the identical rigorous approval course of as brand-name medication made by Novo and Lilly. Specialists fear the dearth of oversight is placing sufferers in danger. The FDA has mentioned it’s conscious of hospitalizations probably linked to the copycat medication, however that opposed occasions are seemingly being underreported.
“We assist the bi-partisan name for the FDA to crack down on counterfeit and illegally bought weight-loss medication,” mentioned a spokesperson for Hims & Hers Well being Inc., one of many telehealth companies that sells compounded GLP-1s. “We recognize lawmakers’ recognition that reputable compounded drugs allotted by state-regulated pharmacies are usually not counterfeit. Affected person security should all the time come first.”
Novo and Lilly have discouraged shoppers from utilizing compounded and counterfeit merchandise, together with suing telehealth companies that promote the copycat variations and dealing with border brokers to grab unlawful shipments. Underneath the Biden administration, the businesses repeatedly urged the FDA to take motion, however the company principally restricted its actions to issuing shopper warnings — at the same time as its high drug official publicly acknowledged security issues.
Underneath the Trump administration, the HHS has additionally targeted extra closely on different points, akin to banning meals dyes and inspecting vaccine schedules.
In the meantime, lawmakers are ramping up their requires motion. State attorneys and different lawmakers have despatched letters to the FDA and Federal Commerce Fee advocating for better transparency across the remedies and extra scrutiny round advertising practices.
(Updates with assertion from FDA in sixth and seventh paragraphs.)
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