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DTC-In-Perspective by Bob Ehrlich

Congress Acts on Telemedicine Drug Advertising Regulation

March 4, 2025 0

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.

Bob Ehrlich

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DTC-In-Perspective by Bob Ehrlich

Revolutionizing Pharma: The Rise of Direct to Consumer Pharmaceutical Drugs

December 3, 2024 0

One of the current trends in DTC marketing is the availability of some branded drugs shipped directly from the manufacturer. Some pharmaceutical companies are starting to cut the wholesalers and retailers out of the purchase cycle. While still in its infancy, the direct to consumer operations have enormous implications for how consumers will get their drugs in the future. Eli Lilly and Pfizer are the first to offer this service.

The direct sales of drugs to consumers have been in place for nearly a decade from non-pharmaceutical companies. Hims started in 2017, and there are now many non-pharmaceutical companies diagnosing, prescribing, and shipping to consumers. Drug companies have decided to enter direct sales in the past few years.

Why are drug companies now getting into the direct sales business? There are several good reasons for this new approach. First, drug makers are now seeing a huge growth in direct sales companies offering compounded versions of their drugs. These are cheaper and, in categories like weight loss, have lots of appeal to consumers. Second, cutting out the middlemen gives drug companies better ability to lower drug prices. Third, there are enormous marketing advantages to knowing your customers and tracking their purchases over time. Fourth, drug companies are concerned about counterfeit drugs through reimportation which is a real problem for consumers ordering from the internet. Fifth, consumers like the convenience of getting diagnoses and prescriptions without having to see their doctor in person.

“Cutting out the middlemen gives drug companies better ability to lower drug prices, know their customers, and combat counterfeit medications – reshaping how consumers access healthcare”

I would expect that drug companies will greatly expand their direct to consumer programs and use traditional DTC advertising to make consumers aware of their purchase options. The direct business will not replace retail drug stores or drug wholesalers for most drugs. Most of the growth will come from lifestyle categories like weight loss, sexual dysfunction, sleep disorders, migraine, anxiety, and depression. Any category where an online survey and virtual healthcare can diagnose a consumer condition is an opportunity for direct sales.

There are legitimate ethical and policy implications to expanding direct pharmaceutical distribution. The non-pharmaceutical direct business makes it easy to get prescription meds through an online survey or telemedicine that inappropriate prescribing is possible. I expect pharmaceutical companies will have better controls in place to make sure a prescription is justified. After all, these big pharma companies have a lot more to lose in public reputation and through regulatory, public policy, and legal actions.

The Amazoning of America has certainly shown that consumers love the convenience of shopping from home. Getting a diagnoses, prescription, and delivery online is becoming accepted for many drug categories. Drug companies see the potential and expect major growth in this channel.

Bob Ehrlich