In Healthcare Brew’s article, “Despite FDA crackdown, unapproved GLP-1s still threaten the industry,” Todd Harrison and Claudia Lewis offer insight into the regulatory and safety challenges surrounding compounded GLP-1 drugs. The following is an excerpt:
The FDA is putting its foot down on compounded GLP-1 drugs—well, kind of.
The agency has sent “thousands” of letters warning telehealth and pharmaceutical companies about misleading advertising since September, per a March 3 release.
More than misleading advertising, though, there’s a potentially bigger concern at hand: Some online sellers might not be legal compounders at all but counterfeit producers using manufacturers that aren’t making them in a sterile manner.
This threatens the reputation of compounding that is done safely and by the book, Todd Harrison, partner and co-chair of the FDA Group at law firm Venable, told us.
“By not paying attention to who these compounding pharmacies are, we run a greater risk of a real safety issue happening,” he said. “That could have an impact on the compounding pharmacy [business] in the long run because all it [takes is] one death and all the cards fall.”
Compounding, at its core, is intended to be “specialized” to the needs of an individual patient, Claudia Lewis, another Venable partner and co-chair of the FDA Group with Harrison, told us.
“It becomes a gray area when it’s mass-produced and mass distributed,” she said.
Safety concerns. It can be dangerous if compounders don’t do things by the book, experts say.
Legit compounding companies buy active pharmaceutical ingredients for their drugs from FDA-registered manufacturers. But some companies are selling “compound” drugs with imported active pharmaceutical ingredients from plants that aren’t inspected or assessed by the FDA, per a page on the agency’s website that was last updated Feb. 4.
Some illegitimate GLP-1 copycats may also contain salt forms of semaglutide with active ingredients that are different from those in the drugs approved for compounding by the FDA, per the agency’s website.
“We don’t know whether these other salts or these alternative salts of the same ingredient have the same benefit,” Harrison said. “In essence, these are unapproved new drugs. And [being a] compounding pharmacy is not a license to create unapproved new drugs.”
For the full article, click here.