Off-label, on-demand: The problems with drug delivery start-ups

April 10th, 2019

You may have seen the advertisements for companies like Hims, Kick, and Roman, that promise an easier way to access prescription drugs for conditions such as hair loss, erectile dysfunction, and anxiety. Rather than making an appointment to see a doctor and traveling to the pharmacy, customers can use these startups to connect with doctors online, who prescribe medications that are mailed directly to the customer. 

As convenient as this drug delivery system sounds, health policy experts are raising concerns about the safety and legality of offering these drugs on-demand, especially those that are being prescribed off label. For example, Hims advertises Sertraline for premature ejaculation on its website, making claims about the drug’s ability to “lengthen you and your partner’s sexy time.” However, you have to read the fine print to find out that the drug is not approved by the FDA to treat this condition. Similarly, Kick offers beta-blockers on demand to that promise to help you “nail the interview” and “speak confidently.” Kick says they deliver “FDA-approved prescriptions,” but propranolol is not FDA-approved to treat anxiety, which is not clear on their website.

Even for drugs that are approved for the advertised uses, a New York Times article found that startups’ safety and risk information was lacking. For example, a shipment of Addyi for low female sexual desire did not contain important safety information in their usage guide about not taking the medication with alcohol, even though the drug manufacturer’s protocol requires patients to receive counseling from a pharmacist on avoiding alcohol before taking the drug. It’s also worth noting that the startup Hers that delivers Addyi does not give explicit information of the drug’s absolute benefits on the webpage, which are not very impressive.

The drug delivery startups have skirted around regulation by saying that they are a third party unaffiliated with the drug manufacturer. The companies insist that they don’t make doctors prescribe these pills, they only connect doctors with patients, and the doctors can evaluate whether or not the drug would be appropriate for their condition. However, it seems as though the startups view the doctor’s visit not as an important step for determining appropriateness of the medication, but as an inconvenient hurdle needed to be cleared as quickly as possible. As New York Times reporters found, many of the interactions between patients and doctors do not even involve a phone call or video call, just a few text messages back and forth. One of these messages did not even have a doctor’s name in the message, making it unclear who was actually signing off on the prescription.

The proliferation of direct-to-consumer drug delivery may also increase medicalization, the labeling of normal human variation into a medical condition. Patient advocates have long argued that the marketing campaign around Addyi medicalizes female sexual desire.”The notion of normal sexual functioning is culturally and socially determined,”  psychologist and activist Leonore Tiefer. Similarly, the advertisements for propranolol to treat anxiety “suggest a normal pathology is a sickness,” said Nicolas Terry, director of the Hall Center for Law and Health at Indiana University, quoted in Bloomberg

Providing easier access to needed medications is a laudable goal, but these drug delivery startups are medicalizing conditions and creating demand for drugs unnecessarily, while skirting by existing regulatory standards. These startups should be viewed with serious scrutiny before they lead to overprescribing and patient harm.