Hims & Hers launches GLP-1 shortage tracker in its battle with the FDA
11/13/2024 22:01Hims & Hers is launching a tracker of GLP-1 shortages to push back against the FDA's recent moves to end compounding copycats of the blockbuster drugs.
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.
He credits the company's success with the ability to personalize doses and adjust in smaller frequencies than the step-up doses provided by the commercial brands. For example, a starter dose of Novo’s Ozempic is 25 milligrams. The next step up is 50 milligrams. But if a patient can’t handle that step, compounding can provide a smaller adjustment and eventually get up to 50 milligrams, Dudum explained.
Experts have been debating the risks of untested copycats, but the unprecedented demand for the drugs has given pharmacies a golden opportunity. It is why the pharmacies have sued the FDA over the shortage, claiming that the method to determine the end of the shortages relies on companies self-reporting.
Hims' business has grown significantly, as have other telehealth platforms like Ro, due to GLP-1 compounding access.
Anjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, care services, digital health, PBMs, and health policy and politics. That includes GLP-1s, of course. Follow Anjalee on most social media platforms @AnjKhem.
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