An ad during the Super Bowl drew attention to combination drugs and related legislation. (Image credit: Carol Yepes via Getty Images)
A Super Bowl commercial for telemedicine company Hims & Hers has come under fire from critics who say the weight-management drug ad misled consumers by hiding important details.
At the center of the controversy are so-called combination drugs, which are not subject to the same level of regulation as brand-name or generic drugs and have not received formal approval from the Food and Drug Administration (FDA).
In a commercial that positioned Hims & Hers as an alternative to “Big Pharma” and a system that “keeps Americans sick and stuck,” the company presented itself as a service that offers affordable GLP-1 agonists, or semaglutides, a class of medications that includes Ozempic and Wegovy. Brand-name versions of these drugs have received FDA approval to treat type 2 diabetes and obesity, as well as related conditions like cardiovascular disease.
Hims & Hers offers combination versions of these medications that are not FDA approved.
However, it took a keen eye to spot the warning in the Hims & Hers ad, as it was printed in small white type on a gray background. The ad also did not comply with the practice specified for FDA-approved drugs, which requires listing possible side effects and contraindications — that is, medical conditions or treatments that may interfere with the safe use of the drug.
Critics say this is a problem.
“Mass marketing and mass production of complex drugs are jeopardizing the safety of our drug supply,” said Shabbir Imber Safdar, executive director of the Partnership for Safe Medicines, a nonprofit coalition of supply chain stakeholders, from manufacturers to wholesalers and patient advocates. “We’re not having a conversation about this, and we’re not even educating the American people about it.”
What are combination drugs?
There is a common misconception that what clinics like Hims & Hers offer — at a fraction of the cost of brand-name pharmaceuticals — are generics. However, combination drugs are not generics, which must be made with the same ingredients and technology as brand-name pharmaceuticals.
In contrast, combination drugs are created using the same active ingredients as generic and brand-name drugs, but without the same manufacturing and labeling controls.
There are two types of places where compounding drugs are done. The first are small or community pharmacies, where pharmacists can make limited amounts of medication for patients with special needs. That’s why compounding drugs exist, Safdar told Live Science: A pharmacist might need to make a drug that’s in short supply or change an “official” version of a drug. For example, they might create a liquid form of a drug that’s only available as a pill for a patient who can’t swallow pills, or change an inactive ingredient for a patient with an allergy. These pharmacies are regulated by state pharmacy boards.
Combination drugs can also be manufactured in so-called outsourced facilities, some of which are very large. These facilities are inspected by the FDA for safety, and manufacturers are required to purchase ingredients from FDA-approved suppliers. However, the resulting drugs and their manufacturing process are not subject to clinical trials, meaning the resulting drugs are not FDA-approved.
They are also not subject to the same level of supply chain tracking as FDA-approved drugs. Any FDA-approved drug, whether generic or brand, has a unique serial number that links it to the manufacturer. Combination drugs are not subject to this requirement.
“There is a serious problem if you are given a drug in a drug manufacturing facility that was prescribed by a doctor you have never met in person, because now you are holding in your hand a vial that you have to inject yourself with and there is really no way of knowing
Sourse: www.livescience.com
