The Hims & Hers Super Bowl Ad: A Look at the Controversy & the Role of Compounded Medications

Executive Summary: 

• The Hims & Hers Super Bowl ad highlighted the high cost of weight-loss medications and promoted compounded semaglutide as an alternative, leading to controversy over its messaging, safety disclosures, and regulatory implications.
• Compounding pharmacies play a key role in personalizing medications by altering dosage forms, removing allergens, or combining ingredients, though they are regulated differently from FDA-approved drug manufacturers.
• The FDA permits compounding pharmacies to produce alternatives to FDA-approved drugs in cases of shortages, as seen with semaglutide (Wegovy, Ozempic) and tirzepatide (Mounjaro, Zepbound), ensuring continued patient access to essential treatments.
• Understanding the differences between branded, generic, and compounded medications is crucial for informed healthcare decisions, as each category varies in cost, availability, regulation, and patient suitability.
  
  

Locke Bio empowers telehealth providers with innovative solutions to navigate the complexities of medication accessibility, regulatory compliance, and patient-centric care. As the conversation around compounded medications and FDA-approved treatments evolves, ensuring transparency, quality, and reliable access to essential medications is more important than ever. Our platform streamlines operations while maintaining compliance, and our partnership with LegitScript provides expedited certification services for telehealth businesses.

Want to learn how Locke Bio can support your telehealth business with trusted, compliant medication solutions? BOOK A DEMO HERE

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The Hims & Hers Super Bowl Ad: A Look at the Controversy & the Role of Compounded Medications

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The Hims & Hers Super Bowl ad stirred controversy by criticizing the high cost of weight-loss medications and promoting its own compounded semaglutide as a more affordable alternative. The ad positioned the company as a disruptor to the healthcare system but faced backlash from lawmakers and pharmaceutical groups who argued it was misleading and lacked proper safety disclosures. Critics raised concerns about the marketing of compounded medications, which are not FDA-approved, while Hims & Hers defended the ad as a call for more accessible healthcare. The debate highlights broader issues around medication affordability, regulation, and public awareness of compounded drugs.

In this article, we will break down the controversy surrounding the ad, explain why compounded medications are allowed to be sold, and provide an educational overview of compounding pharmacies and how they differ from traditional pharmaceutical manufacturers. As telehealth continues to reshape healthcare, ensuring compliance, transparency, and patient safety remains essential. Locke Bio provides regulatory support and platform solutions for telehealth providers navigating these challenges, to learn more book a demo here. 

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What is a Compounding Pharmacy?

A compounding pharmacy is a specialized facility that creates personalized medications based on a patient’s needs. Unlike large pharmaceutical manufacturers that produce drugs on a mass scale, compounding pharmacies mix ingredients to tailor-make medications as prescribed by a healthcare provider. 

What Compounding Pharmacies Do:

• Modify dosage strengths and forms (e.g., turning a pill into a liquid for easier consumption).
• Remove allergens or unnecessary fillers.
• Combine multiple medications into a single dose for patient convenience.
• Provide alternatives when a drug is unavailable due to shortages.

Compounded drugs are regulated by state pharmacy boards and must adhere to guidelines set by the U.S. Pharmacopeia (USP). However, because they are not subject to FDA approval, compounding pharmacies cannot claim that their safety and efficacy matches that of brand-name drugs. This is because these compounds have not gone through the same clinical trials as the brand name medications. Through Locke Bio’s LegitScript partnership, our services can help telehealth providers ensure compliance with evolving regulations, protection both businesses and patients. 

Clarifying the Regulatory Landscape for Compounded Medications

In the United States, the regulation of compounded medications is primarily governed by Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

• Section 503A applies to traditional compounding pharmacies that prepare medications based on individual prescriptions and are exempt from certain FDA requirements. However, they cannot produce large batches for mass distribution and are regulated by state pharmacy boards.
• Section 503B defines outsourcing facilities that manufacture large batches of compounded medications for healthcare facilities without requiring individual prescriptions. Unlike 503A pharmacies, these facilities must comply with FDA regulations, including cGMP standards, registration, and inspection requirements.

For telehealth providers looking to integrate compounded medication offerings, ensuring compliance with these regulations is crucial. Locke Bio helps telehealth brands simplify regulatory compliance and integrate platform solutions, while our partnership with LegitScript ensures adherence to industry standards through streamlined certification services.

Addressing Common Misconceptions About Compounded Medications

There are several prevalent misconceptions regarding compounded medications that can lead to confusion or unwarranted concern:

• Misconception 1: Compounded Medications Are Not Regulated
  While compounded medications are not FDA-approved, compounding practices are regulated. Traditional compounding pharmacies (503A) are overseen by state pharmacy boards and must comply with standards set by the U.S. Pharmacopeia (USP). Outsourcing facilities (503B) are subject to FDA oversight and must adhere to cGMP requirements.
  
  
• Misconception 2: Compounded Medications Are Unsafe
  When prepared by qualified pharmacists in compliant facilities, compounded medications can be safe and effective. However, because they are tailored to individual needs and not subject to the FDA's premarket approval process, it's essential for patients to consult with their healthcare providers and use reputable compounding pharmacies.
  
  
• Misconception 3: Compounded Medications Are Only for Rare Conditions
  Compounded medications are used for a variety of reasons, including altering dosage forms for easier administration, removing allergens, or combining multiple medications into a single dose. They are not limited to rare conditions but are utilized whenever a patient has specific needs that commercially available medications cannot meet, such as drug shortages.

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Why Are These Medications Allowed to Be Sold?

One key reason why compounded medications are available is the ongoing shortage of FDA-approved drugs. When commercially available drugs are in short supply, the FDA allows compounding pharmacies to create custom formulations under specific regulations.

GLP-1 receptor agonists like semaglutide (Wegovy, Ozempic) and tirzepatide (Mounjaro, Zepbound) have seen unprecedented demand, leading to widespread shortages. Because these medications are not always available through traditional pharmaceutical channels, compounding pharmacies are permitted to formulate compound equivalents to ensure that patients who need them can still receive treatment.

Compounding is particularly useful when:

• A commercially available drug is out of stock or unavailable.
• A patient needs a customized formulation (e.g., removing allergens, adjusting dosage, or changing the delivery method).
• A patient cannot tolerate certain inactive ingredients found in the branded version.

While compounded medications serve an important role, they do not undergo the same rigorous and lengthy FDA approval process as mass-manufactured drugs. This is why safety and quality concerns remain a point of discussion in the healthcare community.

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Understanding Branded, Generic, and Compounded Medications

Branded Drugs

Branded drugs are developed and patented by pharmaceutical companies. These medications undergo extensive research, clinical trials, and FDA approval to ensure safety and efficacy. Because of this process, branded drugs are often more expensive, though they are covered by many insurance plans. However, availability can be an issue, especially during periods of high demand or manufacturing delays.

For telehealth providers, understanding these distinctions is essential when offering medications to patients. Locke Bio’s platform supports seamless integration of branded, generic, and compounded drug offerings, ensuring compliance with regulatory standards. Additionally, LegitScript certification helps telehealth businesses verify adherence to industry regulations, building trust with patients and regulators alike.

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Pros:

• FDA-approved for safety and efficacy.
• Standardized dosing and formulation.
• Often covered by insurance.

Cons:

• Higher cost due to research and development expenses.
• Limited availability during shortages or high demand.

Generic Drugs

Generic drugs are FDA-approved copies of branded drugs that contain the same active ingredients. Once a patent expires, other companies can produce generics, making them more affordable. While generics provide the same therapeutic effects as branded drugs, they may contain different inactive ingredients, which can affect tolerability for some patients. Additionally, if a branded drug is in shortage, the generic version may also become difficult to obtain.

Pros:

• More affordable than branded drugs.
• FDA-approved with the same active ingredients as branded drugs.
• Widely available in most cases.

Cons:

• May contain different inactive ingredients, which can affect tolerability.
• Availability can still be impacted by shortages.

Compounded Medications

Compounded medications are custom-made by pharmacies based on a provider’s prescription, offering personalized options like adjusted dosages or allergen-free alternatives. They are useful during drug shortages but lack FDA approval, so patients should consult their healthcare provider for safety and effectiveness.

Pros:

• Customized formulations tailored to patient needs.
• Useful when a drug is unavailable due to shortages.
• Can provide allergen-free alternatives.
• Use FDA approved ingredients.

Cons:

• Not FDA-approved, meaning quality and consistency can vary.
• May not always be covered by insurance.
• Limited oversight and variability between different compounding pharmacies, which may affect reliability and potency.

Compounded medications play a crucial role in modern healthcare, particularly during drug shortages and for patients with specific medical needs. While they do not go through the same FDA approval process as mass-manufactured drugs, they are regulated and serve a legitimate purpose in providing alternative treatment options.

The Hims & Hers Super Bowl ad brought national attention to the high cost of weight-loss medications and the role of compounded alternatives in expanding access to treatment. While compounded medications serve an important function, particularly during drug shortages, they also require clear communication about their safety, efficacy, and regulatory differences from FDA-approved drugs. The controversy surrounding the ad highlights the delicate balance telehealth providers must maintain—offering innovative, affordable healthcare solutions while ensuring that patients receive transparent, accurate information. Locke Bio only partners with LegitScript certified pharmacies to guarantee that patients receive medications that meet strict regulatory standards. This commitment ensures that all treatments are safe, compliant, and dispensed with proper patient education, empowering individuals to make informed healthcare decisions. As the telehealth industry continues to evolve, responsible marketing, regulatory compliance, and patient education will be critical in building trust and advancing the future of digital healthcare.

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Locke Bio is committed to helping telehealth providers stay informed and navigate the evolving landscape of medication accessibility and regulatory compliance. As the conversation around compounded medications continues, understanding the nuances of branded, generic, and compounded drugs is essential for both providers and patients. By prioritizing education and transparency, we can work toward a healthcare system that balances innovation with patient safety and accessibility. Through our partnership with LegitScript, we also offer certification services to help telehealth businesses meet the highest regulatory standards and operate with confidence.