
Hims & Hers vs. Novo: The GLP-1 Compounding Crackdown
Hims & Hers stepped on some toes and stirred up controversy with their preemptive announcement of their own GLP-1 pill—a compounded version of Wegovy.
They've since backed off, but this battle won't go away anytime soon. It'll become a trend we'll see among direct-to-consumer digital health companies like Hims & Hers.
In this article, I'll provide details on the ongoing feud between Hims & Hers and Novo Nordisk (the maker of Wegovy), briefly highlight the trends we're seeing in the D2C space around weight loss, and then tell you how this all impacts patients, physicians, and the health system.
The Deets: Hims & Hers vs. Novo
Direct-to-consumer company Hims & Hers has had quite the February:
Compounded Semaglutide Pill Announcement (February 5th): Hims & Hers advertised their compounded semaglutide pill, which has "the same active ingredient as Wegovy." The pill would cost $49 for the first month and $99 monthly thereafter—about $100 less than Novo's Wegovy pill, which only recently hit the market.
Hims & Hers Accused of Violating Food, Drug, and Cosmetic Act (February 6th): The HHS general counsel announced on X that Hims & Hers had been referred to the Department of Justice for violations of the Food, Drug, and Cosmetic Act (federal law). This act mandates drug manufacturers submit evidence of new drugs' safety and effectiveness before marketing and distribution to the public. The FDA commissioner also said the agency would take steps to restrict GLP-1 active ingredients intended for use in compounded drugs that companies like Hims & Hers are mass marketing.
Hims & Hers Retreats on Compounded Semaglutide Pill (February 7th): The company announced they'd pause their compounded semaglutide pill given the heat it received from stakeholders across the industry.
Novo Sues Hims & Hers (February 9th): Novo filed a patent infringement lawsuit against Hims & Hers, asking to permanently ban the sale of unapproved compounded drugs. Hims & Hers fired back, saying Novo is weaponizing the U.S. judicial system to limit consumer choice.
All of the above drama centers around “compounding.” Here’s what you should know about compounding pharmacies:
Compounding pharmacies play a vital role in providing customized medications for patients with specific needs that standard drugs cannot address. However, it’s crucial for consumers to understand that compounded medications are not FDA-approved and may carry risks, particularly when sourced from unregulated online pharmacies.
Compounded medications are not equivalent to generic or FDA-approved alternatives. They only contain the same active pharmaceutical ingredient as the FDA-approved version but are formulated differently to meet specific patient needs. Making claims about the safety or efficacy of compounded medications is illegal under the Federal Food, Drug, and Cosmetic Act.
The Direct-to-Consumer Market and GLP-1s
The direct-to-consumer weight loss space exploded as data on GLP-1 medications like semaglutide and tirzepatide proved their effectiveness. More physicians began prescribing these meds, but supply couldn't keep up with demand. This created a shortage of GLP-1s, landing them on the "FDA Drug Shortage List." When a drug appears on this list, compounding pharmacies can step in to produce medications containing the same active pharmaceutical ingredients as semaglutide or tirzepatide.
Seeing the business opportunity, direct-to-consumer digital health companies partnered with compounding pharmacies to mass-produce these GLP-1s. They flocked to the weight loss space, offering easy, seamless access to GLP-1s. Even telehealth companies focused on general care pivoted to "weight loss." Look no further than 23andMe's Lemonaid Health (RIP). The space has become incredibly saturated. Only a select few companies (e.g., Virta Health) are putting in the effort to create an integrated, all-encompassing service for weight loss and diabetes.
The issue now—which I predicted way back when—is that the FDA removed semaglutide and tirzepatide from the drug shortage list. Compounding pharmacies can no longer mass-produce them. With the FDA threatening to crack down on digital health companies still using compounding mechanisms to mass-market their products, the entire foundation and business model of these companies crumbles. Investors fear this. Hims & Hers' stock price has been declining since October ($63 → $15 as of 2/12), starting around when the FDA sent letters to dozens of compounding pharmacies informing them of their violations. Example below:
[The FDA] has observed that your website offers various compounded drug products, including retatrutide, semaglutide and tirzepatide.1 As described below, your retatrutide drug products are unapproved new drugs and misbranded drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a), 502(f)(1), 301(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 355(a), 352(f)(1), 331(a) and 331(d)]. In addition, your claims concerning compounded semaglutide and tirzepatide products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].
This was enough to rattle investors!
The way I see it: regulatory scrutiny is intensifying as drug shortages resolve, and these D2C companies face an existential challenge. They can either adapt their business models or risk collapse. The era of easy GLP-1 compounding is ending, and only those who pivot to sustainable, compliant healthcare delivery will survive.
Dashevsky's Dissection
Hims & Hers won't be the only digital health company to face heat for their compounding practices. So how will this impact key stakeholders?
Patients
Patients have been caught in the middle from the start. When GLP-1 shortages hit, compounding pharmacies offered a lifeline—affordable access to medications that insurance wouldn't cover and pharmacies couldn't stock. Companies like Hims & Hers have made access seamless.
But now that the FDA is cracking down and semaglutide is off the drug shortage list, that access is vanishing. Patients on compounded GLP-1s for months now face a choice: switch to brand-name versions (which cost 10x more) or stop treatment entirely. We already know from prior data that discontinuation rates are brutal—84% of patients without diabetes stop GLP-1s within two years. This regulatory shift will only make that worse.
The bigger issue is trust. Patients don't understand the difference between compounded and FDA-approved medications. They were told these products were safe and effective. Now the government is saying they might not be. That confusion erodes confidence in both digital health companies and the regulatory system itself.
Physicians
The clinical reality is that compounded GLP-1s were never FDA-approved. They contain the same active pharmaceutical ingredient as Wegovy or Zepbound, but they're not equivalent. There's no guarantee of safety, efficacy, or even consistent dosing. The FDA has already issued alerts about dosing errors. As prescribers, that liability sits with us.
The ongoing tension is that we also know that brand-name GLP-1s are prohibitively expensive for most patients (but becoming cheaper, as I discussed last week). Insurance won't cover them for weight loss and out-of-pocket costs are $1,000+ per month. So when a patient comes to us asking for help losing weight, what are we supposed to do? Tell them to pay $12,000 a year? Refer them to a digital health company that's skirting FDA regulations? Prescribe nothing and watch them struggle with obesity-related comorbidities?
This mess forces us to navigate a broken system where the FDA, payers, pharma companies, and digital health startups are all fighting over who controls access.
Digital Health Companies
The era of easy GLP-1 compounding is ending, and the business model for most weight-loss digital health companies is collapsing with it. Hims & Hers' stock is declining. Investors are spooked.
Companies that survive this will need to pivot. A few options:
Option 1: Partner directly with pharma companies to offer brand-name GLP-1s at negotiated prices. But that's expensive, and margins are thin. Novo and Lilly aren't exactly incentivized to help digital health companies undercut their pricing.
Option 2: Build truly comprehensive weight management programs that go beyond just prescribing GLP-1s. Think integrated care models like Virta Health that combine medication, nutrition, coaching, and behavioral support. This is the sustainable play, but it's harder to scale and requires real clinical infrastructure.
Option 3: Pivot to a different clinical vertical entirely. Some companies will abandon weight loss and chase the next high-margin, high-demand medication category. We've already seen this playbook with telehealth companies jumping from general care to GLP-1s to whatever's next.
The companies that don't adapt will disappear. We've already seen this pattern before with the crack down on digital mental health companies shelling out ADHD medications.
In summary, this Hims & Hers drama is a preview of what's coming for the entire direct-to-consumer weight loss industry. Patients will lose affordable access to GLP-1s, physicians will be stuck managing the fallout, and digital health companies will either pivot to sustainable models or collapse. The era of compounded GLP-1s is ending, and only the companies that built real clinical value—not just regulatory arbitrage—will survive.
AI Will Bring Our Nurses Back to the Bedside
In January 2026, nearly 15,000 New York City nurses went on strike. Safe staffing ratios. Workplace violence protections. Better pay. All familiar demands from their last strike three years ago.
But this time, they added something new: job security in the age of AI.
Dr. Alyssa Chen argues that AI poses a threat to nursing—but not in the way most people think. The technology isn't actually coming for bedside nurses. It's coming for the administrative roles that pulled experienced nurses away from the bedside in the first place.
She walks through the paradox: AI is automating medication refills, pre-op outreach calls, billing code capture, and quality metric reviews—all the behind-the-desk nursing work that became an escape hatch from burnout. Companies like Doctronic, Mount Sinai's AI voice agent "Sofiya," and revenue cycle optimization tools are already replacing hundreds of nursing hours.
So what happens when those administrative advancement opportunities disappear? Dr. Chen makes the case that we might actually solve the nursing shortage we've been fighting for years.
👉 Read Dr. Chen’s full argument here.







