Prescription Advertising in the Digital Age: Patient Safety Requires Better Regulation

The pharmaceutical industry is one of the most regulated industries in the United States.¹ Pharmaceutical companies must discover a new entity, develop it into a drug, complete clinical trials, submit a new drug application (NDA), manufacture it using Good Manufacturing Practice (GMP), and apply to the Food and Drug Administration (FDA) to market the drug. This is a very competitive process as companies want to develop drugs efficiently and within the shortest possible time frame. It is estimated that it takes approximately 10 years to get a drug to market and costs the pharmaceutical company around 1 billion dollars. Hence, it is important that new drugs get prescribed and “sell.” This is what theoretically funds the next new drug development from that pharmaceutical company.

In the traditional sense, pharmaceutical “sales” took place by patients visiting their provider. If deemed appropriate, a prescription is written, and either taken by the patient or electronically sent to a local or mail-order pharmacy (Figure 1). In this model of a patient-centered medical home² patients are serially monitored by their provider and refills are given if the medication is working as desired with minimal adverse drug reactions. The cost-effectiveness of prescriptions is also considered. Community pharmacists play a role by dispensing the medication, educating the patient on the drug, possible side effects, and proper administration technique if applicable. Pharmacists can also relay information to providers about drug effectiveness, drug-drug interactions, drug-disease interactions, patient adherence, and help prevent medication-related errors. Open, accurate, and satisfying communication among these three parties is key.³

Figure 1.

Traditional patient-provider-pharmacist relationship

How Is Technology Affecting the Traditional Medical Home?

In recent years, more and more prescribing is being done outside a traditional medical home. As those that fall in the Millennial generation (born 1981–1996) and Generation Z (born 1997-present)⁴ continue to age, they are not only the patients of today, but also the future. These patients have grown up with technology at their fingertips. The first Apple iPhone was released in 2007 when Gen Z patients were around 10 years old. Most don’t remember a world without smartphones and are a mobile-focused generation.⁵ As mobile technology is ingrained in the daily lives of so many, it is not surprising that consumers of today are seeking medical advice and treatment via electronic means. The use of computer, telephone, and smartphones are popular ways to connect about healthcare even without a prior provider-patient relationship. It is expected this trend will only continue and may even be influenced by future physician shortage forecasts. It is predicted that by 2030, there will be a shortfall of medical doctors in the United States. It is projected the US will have a shortage of up to approximately 121,000 physicians.⁶ Advertisements of digital platforms to provide online care as well as direct-to-consumer (DCT) advertising of pharmaceutical products is the new “norm.” The COVID-19 pandemic also boosted the use of mobile healthcare making telemedicine more common.⁷

Drug Advertising: How Did We Get Here?

A brief review of history reveals in 1938, the Food, Drug, and Cosmetic Act was passed. This law required a drug be safe and could not be marketed otherwise. This law also required the label to include accurate directions for use and warnings about habit-forming potentials.⁸ In 1962, Congress passed the Kefauver-Harris Amendments which granted the FDA jurisdiction over advertising prescription drugs to patients.⁹ The FDA has an Office of Prescription Drug Promotion (OPDP) which is responsible for reviewing reports of misleading or “bad” advertisements and has started a “Bad Ad” Program. It urges healthcare providers to identify and report claims of inappropriate advertising for pharmaceuticals.⁸

In general, three types of advertisements are allowed for prescription drugs (Table 1). Advertisements must include the name of the drug (brand and generic), give at least one FDA approved use of the drug, must not be misleading, have a balance between the drug’s efficacy and risk, and state the most significant risks of using the drug.¹⁰ It is interesting to note the FDA does not see DTC ads prior to their use. Pharmaceutical companies do not submit ads to the FDA for approval; only after they’ve first appeared in public. It is conceivable; therefore, that patients see ads that violate the acceptable types¹¹ (Table 1).

Table 1.

Types of allowable advertisements for pharmaceuticals

Advertisement type	Description
Product claim ad	Names a drug, the condition it treats, and talks about both its benefits and risks.
Reminder ad	Gives the drug's name but not the drug's use
Help seeking ad	Describes a disease or condition but does not recommend or suggest specific drugs

In 2008, the Ryan Haight Online Pharmacy Consumer Protection Act was passed. This requires any practitioner issuing a prescription for a controlled substance to conduct an in-person medical evaluation (with certain specified exemptions) prior to prescribing controlled substances. The prescriber is also required to have conducted one in-person medical evaluation with the patient and may prescribe via telemedicine thereafter.¹² During the COVID-19 public health emergency, these rules were relaxed. Telehealth was now allowed and controlled substance prescriptions (such as Adderall for ADHD) were permissible even if the prescriber and patient had never met in person. Additionally, prescribers licensed and holding a DEA license for one state, could now use that in other states to prescribe via mobile means.

It is unclear what will become of the suspended Ryan Haight Act after the end of the COVID-19 public health emergency that occurred May 11, 2023. It is expected that patient care will be disrupted. The American Hospital Association has called for an outlined plan from the Drug Enforcement Agency (DEA) related to “internet prescribing.”¹³ Some medical and patient advocacy groups are calling on the DEA to continue to allow the relaxed rules especially as it relates to treating substance abuse disorder to prevent barriers to care.¹⁴ It is anticipated that the Biden administration will require patients getting controlled substance prescriptions from providers they’ve never seen in person to have at least one in-person appointment after the public health emergency ends. They will then be able to continue to receive their controlled prescriptions.¹⁵

What Likely Does the Future Hold?

With more consumers averting the primary care medical home model and seeking care via mobile means, direct-to-consumer telemedicine and online digital platforms are offering around-the-clock access for common, nonemergency conditions through phone, live webcam chat, or smartphone applications.¹⁶ A recent investigative report by Khadeeja Safdar and Andrea Fuller published in the Wall Street Journal found in a four-week period during the fall of 2022, approximately 20 companies ran more than 2,100 ads on Facebook and Instagram. Benefits of prescription medications were touted, but details on risks were scarce. Advertisements also promoted medications for non-FDA approved uses and featured testimonials, but did not disclose if these “patients” were paid actors or possibly even company employees. Example medications found in these ads included ketamine and testosterone.¹⁷

A similar investigation found telehealth companies promoting services to help people who aren’t overweight get prescription medications for diabetes that are known to promote weight loss.⁷ Excerpts from these ads read “it’s as easy as just taking the medicine!”, “no diet or exercise needed,” and “they pair you up with a doctor online.”⁷ These ads pushing the newer class of diabetes medications known as GLP1’s (e.g. Ozempic, Wegovy) promote the concept of weight loss with medications as a “quick fix,” instead of the concept of implementing lifestyle modifications that can ultimately help people get and stay at a healthy weight. Let’s also not forget using these medications in non-obese patients is off-label, not without risks, and duration of treatment is ultimately unknown. The promotion of this class of drugs for off-label and possibly inappropriate use may have also contributed to the nationwide shortage and backorder status of these drugs experienced by most pharmacies earlier this year. This impacted actual diabetic patients’ ability to fill and refill these prescriptions on a routine basis.

What are the risks of promoting prescription medications on platforms like Facebook, Twitter, and Instagram? Exposing people, especially minors, to ads related to depression, anxiety, and ADHD (especially during lockdown of the COVID-19 pandemic) treatments was simple. Using viral trends and oversimplification of complex ADHD symptoms made it easy for people to identify with that diagnosis and want to seek treatment. For example, “have you ever felt overwhelmed,” “not want to do your homework?”, and “we can connect you to a team of healthcare providers” were used.¹⁸ Access to online prescriptions is super tempting for internet and social media users. Not having to make a face-to-face appointment or travel to it, eliminating potential embarrassing conversations related to the desired prescription, and then removing travel time to pick up a prescription are all considered benefits to many patients. Simply googling a health-related concern like “hair loss, erectile dysfunction, depression, anxiety, and even ADHD” can land patients on online telehealth platform websites promising to cure or control those conditions and give access to prescription medications in non-threatening ways.

In a three-part Wall Street Journal podcast, “Uncontrolled Substances, Part 3: Anthony”¹⁹ investigative reporter Khadeeja Safdar reveals a Missouri teenager was able to obtain a prescription for an antidepressant through the online platform Cerebral without parental consent. Antidepressants carry a boxed warning related to their use in minors (Figure 2). It appears the patient lied about his date of birth on his intake form for Cerebral. His driver’s license was never verified by the site showing his actual age of 17. He subsequently took his own life.

Figure 2.

Boxed warning on antidepressants Fluoxetine boxed warning:

Antidepressants increased the risk compared with placebo of suicidal thinking and behavior (suicidality) in short-term studies in children, adolescents, and young adults with major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of fluoxetine or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.

Can Anything Be Done?

The American Medical Association (AMA) has been calling for a ban on direct-to-consumer advertising of prescription drugs for years. They cite drug marketings role in higher drug prices.²¹ The future is uncertain. We know the FDA doesn’t review DTC ads prior to their use in usual circumstances. Who is actually regulating what in these advertisements pushing prescription drug ads through online telehealth platforms is not clear. Possibly no regulation is being done in some cases. Congressional leaders are calling for better oversight of such advertising.²² The bombardment of ads on social media promoting prescription drugs with limited or no risk disclosures and for non-FDA approved uses is concerning. The FDA monitors entities like drug manufacturers, distributors, and packers but telehealth startup companies don’t generally fall into any of those “buckets.” We must assume that Congress will continue to urge the FDA to develop a means of oversight necessary to protect patients.

As healthcare providers, we certainly can play a role in reporting DTC advertisements we deem inappropriate. Advertisements for medications or even the online platforms that are pushing them should be scrutinized. Those that don’t relay the proper balance of efficacy and risks, don’t disclose the use of a drug, or don’t name any risks at all should be brought to the attention of the FDA. Information can be sent to the Bad Ad program via email at badad@fda.gov, with a phone call to the Office of Prescription Drug Promotion at 301-796-1200, or even in writing. Educating patients about prescription medications should be left to prescribers and pharmacists; not marketing firms.