The unbalanced playing field between pharmaceutical manufacturers and telemedicine sites selling versions of approved drugs is finally being addressed in Congress. Congress acts on telemedicine drug advertising as senators push for FDA oversight. A number of large telemedicine direct sell sites have emerged in recent years. These sites diagnose, prescribe, and ship versions of popular drugs. When they advertise, they are not currently held to the same regulation as pharmaceutical companies.
Sites like Hims & Hers advertise compounded drugs or the forms of drugs without fair balance requirements. Frequently prescribed categories are weight loss, antidepressants, insomnia, and erectile dysfunction. They are not currently regulated by FDA even though they are manufacturing drugs and advertising them.
Senators Durbin (D-IL) and Marshall (R-KS) are co-sponsoring a bill to require FDA regulation of advertising from these telemedicine sellers. Pharmaceutical companies have been at a competitive disadvantage because these sites often use compounded versions or created combinations of drugs. Drug companies lose sales because these telemedicine drugs often are priced lower.
Telemedicine sites have made diagnosis, prescription, and fulfillment easy for consumers. The problem is they can make efficacy claims without risk and warning information. Drug makers are held to a much higher standard and therefore have an unfair competitive landscape. These direct sale companies are offering a great perceived benefit for consumers. Answer a few medical questions, get prescribed, and receive the drug by mail. I imagine few consumers are turned down from getting prescriptions under the telemedicine process.
Telemedicine sites have made diagnosis, prescription, and fulfillment easy—but without the same regulatory standards as pharmaceutical companies, is it fair competition?
Congress is worried about inappropriate prescribing and the overpromise of efficacy without fair balance, prompting action on telemedicine drug advertising. Drug makers are concerned that compounders are violating patents and creating versions of their drugs which are not going through rigorous quality controls.
While DTC drug advertising receives lots of criticism, it is the most heavily regulated advertising category. Hopefully, that rigorous regulation will now apply to the burgeoning telemedicine industry.
