Hims & Hers launches GLP-1 tracker in response to FDA's shortage decision

 Hims & Hers (HIMS) is launching a new GLP-1 tracker in its efforts to fight back against the FDA’s decision to end compounded GLP-1s on the market.

The tracker allows patients to self-identify, provide their location, and say which brand of GLP-1 drug they are not able to find. The data will be aggregated and regularly published by Hims in order to provide proof to the FDA that the shortages of the branded drugs haven’t ended, according to co-founder and CEO Andrew Dudum.

"We shared, as of a week ago, north of 80,000 people on our platform ... are not able to get access to these medicines and [are] reporting shortage. And that's really only accelerating. Last week, we had more than 2,000 people in one day," Dudum told Yahoo Finance in an exclusive interview.

"The reality on the ground is that it's a very widespread shortage," he said.

The move comes after the FDA took tirzepatide, the key ingredient in Eli Lilly’s (LLY) diabetes drug Mounjaro and weight-loss drug Zepbound, off its shortage list. The agency is also evaluating Novo Nordisk’s (NVO) semaglutide drugs for the same label. After significant pushback, the FDA said it will reevaluate tirzepatide’s status.

The branded drug companies "do not have adequate supply," Dudum said. "On earnings, they say very clearly they expect demand to outstrip supply for years to come. And if you look at the earnings from major wholesalers, you know, the Cardinals, McKesson, etc., the sentiment was the same. We don't have anywhere near enough."

"I think there is an immense amount of pressure that they are applying to the FDA to indicate that they are in widespread availability, but [they] are also themselves communicating the realities on the ground with regard to patients having access," he added.

Once the shortages are declared over, compounding pharmacies have a 60-day window to halt production of copycats — which has been a booming market over the past two years. Some copycats provided by medical spas and wellness clinics have been deemed risky since they use a different type of substance compared to the branded drug formulas.

The same shadow of doubt has been cast over compounded pharmacy drugs since they do not receive the same stringent clinical trial oversight as branded drugs. But Dudum said patients have been getting better care through the compounding process with no greater reporting of issues than the branded drugs and that the FDA tracks all adverse events.

https://finance.yahoo.com/news/hims--hers-launches-glp-1-tracker-in-response-to-fdas-shortage-decision-144818745.html