Hims & Hers launches GLP-1 tracker in response to FDA deficiency decision

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

The tracker allows patients to identify themselves, indicate their location and say which brand of GLP-1 drug they are unable to find. The data will be aggregated and regularly published by Hims to provide the FDA with evidence that the shortage of brand-name drugs has not ended, according to co-founder and CEO Andrew Dudum.

“We shared a week ago that north of 80,000 people on our platform … are unable to access these drugs and (are) reporting shortages. And it’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 removed tirzepatid, the key ingredient in Eli Lilly’s ( LLY ) diabetes drug Mounjaro and weight loss drug Zepbound, from its deficiency list. The agency is also evaluating Novo Nordisk’s ( NVO ) semaglutide drugs for the same brand. After a significant setback, the FDA said it will reevaluate tirzepatide’s status.

The brand-name drug companies “don’t have adequate supply,” Dudum said. “In terms of earnings, they say very clearly that they expect demand to exceed supply in the coming years. And if you look at the earnings of major wholesalers, you know, Cardinals, McKesson, etc., the sentiment was the same. hasn’t near enough.”

“I think there’s tremendous pressure that they’re putting on the FDA to indicate that they’re in widespread availability, but (they’re) also communicating the realities on the ground themselves in terms of patients having access,” added he.

Once the shortage is declared over, compounding pharmacies have a 60-day period to stop production of copycat products – which has been a booming market over the past two years. Some copycats provided by medical spas and wellness clinics have been considered risky as they use a different type of substance compared to the brand name formulas.

The same shadow of doubt has been cast over compounded drugs, as they do not receive the same rigorous clinical trial oversight as brand-name drugs. But Dudum said patients have received better care through the compounding process with no greater reporting of problems than brand-name drugs, and that the FDA tracks all side effects.

He credits the company’s success to the ability to personalize doses and adjust at smaller frequencies than the step-up doses provided by the commercial brands. For example, a starting dose of Novo’s Ozempic is 0.25 milligrams. The next step up is 0.5 milligrams. But if a patient can’t handle that step, compounding can provide a minor adjustment, eventually getting up to 50 milligrams, Dudum explained.

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