During the COVID-19 pandemic, as many stayed home, direct-to-consumer prescription drug advertising—already big business—boomed. Websites, social media, streaming services, and other on-demand platforms became ideal real estate for drug manufacturers, start up clinics, telemedicine practitioners, and others to market drugs, whether they were FDA-approved or not.
There are policies in place to police such ads’ legitimacy, but there’s a catch. The FDA’s prescription drug advertising regulations focus only on entities “that manufacture, distribute, or pack” prescription drugs—leaving a gaping loophole for any company that falls outside that jurisdiction to market their products—and putting vulnerable populations seeking cures at risk. Epidemiology professor Caleb Alexander, MD, and senior associate Thomas Moore recently answered some questions to identify, as Alexander puts it, exactly where “the [drug ad] train went off the rails.”
What is and isn’t allowed when it comes to direct-to-consumer advertising of prescription drugs in the U.S.?
TM: The FDA drug advertising regulations require that advertisements for prescription drugs only promote them for medical uses that have been evaluated and approved by the agency. In addition, the ads must present a fair balance between the benefits and risks.
It is illegal to overstate a drug’s benefits, misrepresent data from studies, or make claims not supported by adequate evidence.
Why are some entities allowed to publish false or misleading information about drugs?
TM: The prescription drug advertising regulations and standards were formulated more than two decades ago when the only business entities that advertised were drug companies, and the main outlets were print and broadcast media. Today all kinds of new businesses promote drugs, online and in social media, and fall into a regulatory loophole.
Keep in mind the important qualification that the FDA regulates only “prescription drugs.” Advertising for over-the-counter drugs, dietary supplements, and other products is regulated by the FTC.
Why is that dangerous for consumers?
CA: While regulations governing drug advertising were designed to target drug manufacturers, we now live in an era where other parties—health care insurers, start-up clinics, telemedicine start-ups—are getting into the business of marketing prescription drugs. And quite a business it is.
The problem is that these entities are not being held to any standard regarding what they can say about the drugs in question—products like ketamine, testosterone, and stimulants for the treatment of ADHD, to name a few—and they are not only misconstruing the evidence, in many cases, they are making outlandish, pants-on-fire claims about these products.
What should consumers consider when encountering drug ads?
TM: Look to see how the risks of the prescription drug are portrayed. Lists of adverse effects should be detailed, complete and have equal prominence to any benefit claims.
CA: Any ad should be taken with a grain of salt; these ads are designed for one main purpose—to boost sales.
How do these ads differ from other prescription drug marketing?
CA: The ads we are talking about are not the typical drug ads seen on TV or drugs prescribed by physicians or nurse practitioners and dispensed by pharmacies. The ads we’re talking about represent a whole new frontier of prescription drug marketing and promotion, and are run not by pharmaceutical manufacturers, but by companies seeking to profit through linking their services to the provision of select prescription drugs.
If you feel you can benefit from a suggested medication, how should you confirm an ad’s credibility?
TM: Go to the FDA website and read the objective Medication Guide for the drug of interest.
CA: Decisions about whether or not a treatment is worth pursuing should be based on careful consideration by patient and clinician. Full stop.
Should you report false ads?
TM: It requires effort and some research to use, but the FDA provides “The Bad Ad Program” to help identify and report potentially false or misleading prescription drug advertising.
Are certain groups more vulnerable to this type of marketing?
TM: People with serious diseases or a condition that impacts their daily life often embrace drugs seeking “hope” and are eager to try something. They are the most vulnerable to being misled.
CA: Some of the more egregious and concerning examples of this problem are reflected in the rapid growth of telemedicine start-ups offering simplified access to powerful drugs with non-trivial risks, such as prescription stimulants for the treatment of ADHD. Another prime example is ketamine.
Unfortunately, the evidence to support the types of therapies we are talking about is often quite limited, and it's also complex.
What can be done to protect consumers?
CA: It’s not fair, reasonable, nor practicable to expect consumers to be able to sort through these misrepresentations—and I don’t believe it’s the system that was intended. It’s time to close the loophole that is allowing this to happen.
Companies that are marketing and promoting these drugs should be held to the same standards as drug manufacturers, whether or not they are the ones actually producing the product.
When it comes to the risks of false advertising, and the threat that it poses to public health, there is nothing fundamentally different between a telemedicine start-up making outlandish claims and such claims arising from the drug maker itself.
Morgan Coulson is an editorial specialist in the Office of External Affairs at the Johns Hopkins Bloomberg School of Public Health.
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