Introduction
The telehealth infrastructure has spawned a new business model. Companies such as Hims & Hers Health, Inc. and Ro are online platforms engaging in direct-to-prescription marketing.Footnote 1 Pharmaceutical companies, too, have partnered with such online platforms,Footnote 2 though one pharmaceutical power player abruptly ended the collaboration.Footnote 3 Heavily advertised on social media, these platforms promise quick and easy access to prescription medication, without the expense and burden associated with a traditional doctor’s visit, by instantly pairing consumers with prescribers via telemedicine.Footnote 4 While direct-to-consumer advertising of drugs is a familiar phenomenon,Footnote 5 the new direct-to-prescription model dramatically shortens the path to obtaining prescription medication. Whereas the traditional direct-to-consumer marketing approach typically encourages consumers/patients to consult with their doctors about the advertised drug, direct-to-prescription marketing comes with at least an implied promise to deliver the advertised product (“in discreet packaging”) directly to the consumer.
Though ostensibly built on telemedicine’s remote professional setting, the direct-to-prescription business model strains the values traditionally underlying the relationship between prescriber and patient. First, the professional advice-giving component often appears to be lacking. For example, side effects or interactions of prescription medications for conditions such as hair loss or erectile dysfunction have been inadequately discussed and apparently surprised consumers.Footnote 6 In fact, some consumers who experienced significant side-effects reportedly obtained the medications without consulting a professional at all.Footnote 7 (Here, the U.S. Food and Drug Administration (FDA) has recently stepped in with a warning.Footnote 8) Prescription medications with high potential for abuse, such as Adderall, were evidently dispensed with little oversight.Footnote 9 The platforms’ terms of use routinely exclude liability both for the platforms themselves and, perhaps more alarmingly, also for the prescribing professionals.Footnote 10 And some prescribers reportedly went so far as to scour the fine print of their contracts with platforms to ascertain that they in fact are allowed to decline a prescription.Footnote 11 None of this should happen in an ordinary doctor-patient relationship. Second, dispensing pharmacies in some instances offered questionable products to consumersFootnote 12 while others provided insufficient dosing guidance.Footnote 13 Widely publicized with respect to GLP-1 drugs, the partnership of compounding pharmacies — licensed pharmacies which are permitted to create medication out of its component parts without FDA review or approval — and online platformsFootnote 14 gained particular prominence during the brand-name weight-loss drugs’ shortage.Footnote 15 The pharmacies’ role in the direct-to-prescription model raises distinct, but no less serious, legal and ethical concerns related to pharmacy practice.
The growing direct-to-prescription business model is convenient for patients/consumers. The model’s very existence and increased consumer attention reflects the ongoing significant primary care shortage, particularly in rural areas;Footnote 16 potential lack of or rollbacks in insurance coverage;Footnote 17 and broader access inequalities.Footnote 18 Future insurance coverage decisions may drive even more patients to these platforms.Footnote 19 The business model also has industry buy-in from big pharma which has latched onto the platforms’ attractiveness to consumers.Footnote 20 But the model’s popularity should not obscure its potential legal and ethical problems. Adopting the best version of the direct-to-prescription model means respecting and enforcing the values underlying the professional-patient relationship. Entrenchment of the worst aspects of this model, by contrast, threatens to undermine the role of professionals, professional ethics, and, ultimately, patient safety.
The entire direct-to-prescription business model hinges on the participation of licensed professionals. These professionals have legal and ethical duties to ensure patient safety. Involvement of these professionals provides a regulatory hook to curtail some of the most serious defects of the direct-to-prescription model without necessarily restraining the practice altogether, an option I do not explore here. Consequently, I suggest that the professional regulation and ethics of telemedicine ought to apply and be fully enforced. Licensing and disciplinary bodies should exercise increased disciplinary scrutiny on professionals (prescribing clinicians and dispensing pharmacists) involved in the direct-to-prescription business model to fully align it with the demands of telemedicine.
Thus far, the emergent literature has focused on the federal Anti-Kickback Statute governing the relationship between pharmaceutical and telehealth companies,Footnote 21 and scholars have also identified incipient research questions concerning regulatory oversight.Footnote 22 This article surveys the legal and ethical problems in the relationship among platforms, prescribers, and patients/customers, and identifies potential regulatory access points. To be sure, federal and state actors may address certain aspects of these problems through a variety of regulatory interventions. Suggesting one avenue of regulation, the remainder of this article offers a sustained focus on the legal framework of professional advice-giving and professional ethics and explains how this framework applies to the problems raised by the direct-to-prescription model.
Technological advancements in professional environments emerge in a densely regulated space characterized by knowledge asymmetries and trust-based interpersonal relationships. Traditionally, the legal and ethical frameworks governing the professional relationship have assumed interactions between human professionals and their clients or patients.Footnote 23 These frameworks are designed to safeguard core values inherent in person-to-person interactions.Footnote 24 Introducing new technologies challenges these foundational assumptions. Therefore, regulatory responses must focus on preserving the essential values underpinning these professional relationships as the modes of interaction evolve.Footnote 25
I. The Professional Relationship
Patients seek professional advice because they lack the specialized knowledge they need to make important life decisions for themselves.Footnote 26 And to make informed decisions about their own health, patients expect that professional advice is “good,” that is, it meets the professional standard of care.Footnote 27 The public has certain intuitions and expectations about the professional relationship. Individuals seeking professional advice expect to receive competent, accurate, and comprehensive guidance reflecting the insights of the profession.Footnote 28 Moreover, intuitively, patients will expect that they can trust their health care provider to act in their best interest, and that they can rely on the professional’s advice. And, if things still go wrong, they expect that the professional will be held liable for harm caused by bad advice. They might also assume an underlying professional code of ethics. These intuitions and expectations reflect the asymmetry of knowledge that characterizes the professional relationship. The corresponding legal safeguards include professional licensing, discipline, fiduciary duties, malpractice liability, and, in the medical context, informed consent.Footnote 29
This framework sets professional advice apart from other types of communications. Whereas the advertising of pharmaceuticals itself falls under the commercial speech doctrine (in fact, the Supreme Court held that the First Amendment protects compounding pharmacies’ advertising of drugsFootnote 30), professional advice-giving — including within the telemedicine relationship — does not. Professional speech is the speech disseminated by a professional to a client or patient within the professional relationship for the purpose of giving professional advice.Footnote 31 It communicates the insights of a professional knowledge community to the listener.Footnote 32
CourtsFootnote 33 and scholarsFootnote 34 have analogized, perhaps too readily, professional speech to commercial speech. The doctrinal starting point for assessing commercial speech remains the canonical, though increasingly criticized, Central Hudson test.Footnote 35 The four-step analysis the Court developed in Central Hudson asks (1) whether the speech is eligible for First Amendment protection.Footnote 36 To qualify, the commercial expression must relate to lawful activity and must not be misleading.Footnote 37 If so, (2) the government’s stated interest must be substantial; (3) the regulation must directly advance the asserted governmental interest; and (4) the regulation must not be more extensive than necessary to serve that interest.Footnote 38 The Supreme Court has ostensibly relied on this doctrinal basis in its expansion of First Amendment protection for commercial speech.Footnote 39 But the Court now affords what comes close to strict scrutiny review in commercial speech cases.Footnote 40 The extent of protection, however, should not be the primary reason to analogize the two types of speech.
The content of the communication between professional and patient and its relation to the body of knowledge that a community possesses is distinctive. So is the imposition of professional malpractice liability and its relation to the professional standard of care. This remains true despite the Supreme Court’s decisions in National Institute of Family & Life Advocates (NIFLA) v. Becerra and Chiles v. Salazar, which noted that no recognized category of professional speech exists.Footnote 41 However, the Court readily conceded that a different doctrinal framework governs the speech between professional and client or patient than other types of speech, including “longstanding torts for professional malpractice” and informed consent.Footnote 42 But “professional speech cannot logically be the same as other speech, yet be governed by a different doctrinal framework.”Footnote 43 Ultimately, despite the Court’s skepticism, the type of speech between professional and patient remains distinctive.
One last observation on commercial speech: licensed professionals may be subject to commercial regulation just like other commercial actors, without First Amendment protection. There still are limits, for example, on false advertising. The Federal Trade Commission (FTC), too, may still intervene to stop fraudulent trade practices without running afoul of the First Amendment.Footnote 44
In sum, professional speech is different from other types of speech, because important legal guardrails apply to professional advice-giving that do not exist elsewhere. They are intended to ensure that the patient receives good advice. Among those guardrails are licensing requirements, informed consent, malpractice liability, and fiduciary duties. Moreover, professional ethics codes govern professionals’ practice. This legal and ethical framework surrounds the professional relationship, demarcating the distinctive social interaction in which professionals give advice to their patients.
II. Telemedicine and Pharmacy Regulation
New forms of professional advice-giving involving various types of technologies raise enduring questions about the nature of the professional relationship. This relationship and its values, rather than the introduction of new technology, should be the center of regulators’ attention.Footnote 45 Some technologies are less likely than others to significantly disrupt the professional advice-giving relationship and therefore do not require a new regulatory framework. The telemedicine setup, for example, is fundamentally akin to the traditional doctor-patient relationship where a new communication technology facilitates the human-to-human interaction. Its novelty lies not in the content of medical advice but rather the method of its delivery.Footnote 46
Telemedicine and the broader term telehealth designate the exchange of medical information by electronic communication from one location to another.Footnote 47 However, telemedicine typically focuses narrowly on direct clinical interactions between providers and patients, while telehealth encompasses a broader range of services that extend beyond clinical care to include preventive screening, ongoing health maintenance, professional education in health-related fields, public health, and health administration.Footnote 48 While telehealth’s roots reach back into the 1950s, its development and maturing accelerated in the 1990s–2000s, with the growth of telecommunication infrastructure, particularly to help address health care access in rural areas.Footnote 49 The COVID-19 pandemic catalyzed telemedicine’s widespread adoption and use.Footnote 50 Regulatory modifications to telemedicine delivery during the pandemic contributed to its spread,Footnote 51 including loosened enforcement of privacy regulations, data sharing protocols, licensing requirements, credentialing standards, oversight of nonphysician practitioners, and mandates for pre-existing doctor-patient relationships,Footnote 52 as did the wider availability of broadband access.Footnote 53
But telemedicine is only one half of the direct-to-prescription business model. The other necessary element are pharmacists, who are subject to professional regulation, and pharmacies dispensing the drugs.Footnote 54 I will discuss both in turn.
A. The Legal and Ethical Framework Governing Professionals in Telemedicine
Telemedicine is supposed to be quality care that reduces access barriers. It replicates the traditional social relationship between professional and patient with the primary difference being the communication technology that enables the relationship to span a larger geographic distance than the traditional in-person office visit. The content of professional advice, however, should remain the same. Accordingly, the legal framework of professional advice-giving governs, despite the new context technological innovation enables.
Licensing. As all other medical professionals, telemedicine providers must be licensed to practice.Footnote 55 In the in-person context, both professional and client are typically in the same location, which is the location in which the professional is licensed to practice, so jurisdictional questions seldom arise. In telemedicine, licensing and medical practice laws are based on the patient’s physical location at the time of the telemedicine visit.Footnote 56 As telemedicine’s popularity and growth increase, physicians seeking to provide services in several states face licensing challenges because of costs associated with obtaining a license and the administrative complexity involved.Footnote 57 The Federation of State Medical Boards’ Interstate Medical Licensure Compact (IMLC) is an effort to ameliorate these difficulties, providing a standardized, faster route for physicians’ licensure in multiple “compact states.”Footnote 58
During the COVID-19 pandemic, licensing requirements for telehealth were relaxed as governors issued “executive orders allowing for health care professionals (e.g., physicians, nurse practitioners, mental health providers, and physical therapists) to practice clinical care across state lines without the need for a permanent license.”Footnote 59 In addition to other emergency medical services,Footnote 60 there are licensing exceptions not contingent on emergency, such as for follow up care.Footnote 61 In some states, there is “a licensure exemption for physician-to-physician (peer-to-peer) out-of-state consultations.”Footnote 62 Exceptions for licensed physicians from neighboring states also exist such that, for example, “the rendering of medical advice or information through telecommunications from a physician licensed to practice medicine in Virginia or an adjoining state, or from a licensed nurse practitioner, to emergency medical personnel acting in an emergency situation is not prohibited.”Footnote 63 These types of exceptions vary significantly among states.Footnote 64 Nonetheless, telemedicine typically requires a licensed provider.
Informed consent. In addition to ordinary informed consent requirements, state laws may demand that the health care professional obtain separate informed consent for use of telemedicine technology.Footnote 65 This aims to ensure the patient understands the risks and benefits of telemedicine.Footnote 66 Best practice requires either to have the patient reaffirm consent at each new visit or affirmatively to acknowledge informed consent at least once a year.Footnote 67 One might question whether these types of specific informed consent laws are appropriate if they do not concern particular limits that telemedicine imposes on diagnosis or treatment. In other words, to the extent that the content of advice and treatment within the relationship stays the same, it may not be necessary to require specific consent for the communication method (a parallel discussion of consent for using a specific technology in the professional relationship is emerging with respect to medical AIFootnote 68).
There may be new challenges in the telemedicine setting such as when “alternatives to care are limited or when a patient faces family and community pressures that may restrict care settings and options. Who should consent, for example, when technology medicalizes the home and involves people beyond the patient?”Footnote 69 In addition, informed consent to accessing telemedicine raises questions as to
just how informed consent is when privacy policies, if they exist at all, are overwhelmingly vague and opaque, while consenting itself is questionable when patients have little choice in services or in accepting these policies. Having to use telehealth services because there is no real alternative to getting care makes meaningful consent difficult.Footnote 70
Malpractice liability. The elements of malpractice — a duty of care to the patient, a breach of that duty, causation between breach of duty and injury — remain the same in telemedicine.Footnote 71 With respect to the standard of care, in 2014 “the Federation of State Medical Boards adopted a policy position stating that ‘treatment and consultation recommendations made in an online setting, including issuing a prescription via electronic means, will be held to the same standards of appropriate practice as those in traditional (encounter in person) settings.’”Footnote 72 However, there continues to be some variation among the states regarding the standard of care. Some states statutorily define the standard of care to differ from in-person encounters:
Treatment recommendations made via telehealth, including issuing a prescription via electronic means, shall be held to the same standards of appropriate practice as those in traditional physician-patient settings that do not include a face-to-face visit but in which prescribing is appropriate, including on-call telephone encounters and encounters for which a follow-up visit is arranged.Footnote 73
As a matter of tort law, this seems fairly unremarkable. Although the clear trend is toward a national standard of care, tort law allows for modifications to that standard to reflect the local circumstances, especially with respect to facilities and equipment.Footnote 74 Reflecting the dynamics in this area of tort law, the draft Restatement (Third) of the Law of Torts
rejects the Second Restatement’s ‘locality rule’ in favor of a ‘national’ standard. However, recognizing that medical practice, professional standards, and laws that forbid or influence certain medical procedures, can still vary widely across the country, many courts that embrace a national standard continue to regard locality-based considerations as among the many factors that can affect a determination of what variations in professional behavior are reasonable under the circumstances.Footnote 75
The baseline question in torts cases, in short, is somewhat variable. Moreover, “there have been too few medical malpractice cases relating to telemedicine to characterize the standard of care.”Footnote 76
Fiduciary duties. Professionals have fiduciary duties to their clients or patients that stem from the knowledge asymmetry between them.Footnote 77 To reiterate, precisely this asymmetry makes the social relationship with the professional valuable to the patient: the professional has knowledge that the patient needs to make important decisions. And to obtain professional advice, the patient entrusts the professional with information. To account for the vulnerable position occupied by the patient in this relationship, the fiduciary duties imposed on professionals are the twin duties of loyalty and care.Footnote 78
The American Medical Association (AMA) Code of Ethics contains an emphasis on fiduciary duties in telemedicine:
All physicians who participate in telehealth/telemedicine have an ethical responsibility to uphold fundamental fiduciary obligations by disclosing any financial or other interests the physician has in the telehealth/telemedicine application or service and taking steps to manage or eliminate conflicts of interests. Whenever they provide health information, including health content for websites or mobile health applications, physicians must ensure that the information they provide or that is attributed to them is objective and accurate.Footnote 79
Professional ethics. The AMA has firmly incorporated telemedicine into the Code of Ethics. Importantly, it states that “physicians’ fundamental ethical responsibilities do not change” in telemedicine.Footnote 80 As a result, the ethical framework continues to apply, which means that “patients need to be able to trust that physicians will place patient welfare above other interests, provide competent care, provide the information patients need to make well-considered decisions about care, respect patient privacy and confidentiality, and take steps to ensure continuity of care.”Footnote 81
Particularly important in this context are the ethical demands around prescribing medication via telemedicine. The AMA opinion on telemedicine states that providers must
[b]e prudent in carrying out a diagnostic evaluation or prescribing medication by: establishing the patient’s identity; confirming that telehealth/telemedicine services are appropriate for that patient’s individual situation and medical needs; evaluating the indication, appropriateness and safety of any prescription in keeping with best practice guidelines and any formulary limitations that apply to the electronic interaction; [and] documenting the clinical evaluation and prescription.Footnote 82
Commentators have noted the importance of information in the telemedicine context, “particularly if there is no previous relationship between clinician and patient, no diagnostic data, little knowledge of the patient’s likelihood of compliance or understanding, and no ability to follow up.”Footnote 83 The lack of data, they warn, increases “the risk of misdiagnosis during a virtual visit” as opposed to in-person care.Footnote 84 To ameliorate the situation, “information sharing [becomes] even more important than previously generally recognized.”Footnote 85 The ethical framework reflects the AMA’s stance that clinicians must have access to information that is not merely available, but accurate, comprehensive, and current. This standard becomes especially critical when no established clinician-patient relationship exists. Health systems must aggregate data across platforms and make it meaningfully accessible to providers; current frameworks fall far short of the interoperability and data-sharing that this demands.Footnote 86
Outside of the telemedicine context, but relevant to this discussion, the AMA Code of Ethics also provides a framework for direct-to-consumer advertising of prescription drugs.Footnote 87 In direct-to-consumer advertising, one concern is that it “carries the risk of creating unrealistic expectations for patients and conflicts of interest for physicians, adversely affecting patients’ health and safety, and compromising patient physician relationships.”Footnote 88 The direct-to-prescription model exacerbates these concerns. Consequently, the ethical demands to “[r]emain objective about advertised tests, drugs, treatments, and devices, avoiding bias for or against advertised products,” to “educate patients about why an advertised test, drug, or device may not be suitable for them, including providing cost-effectiveness information about different options,” and to “[r]esist commercially induced pressure to prescribe tests, drugs, or devices that may not be indicated” become even more relevant.Footnote 89 Moreover, the reported lack of clarity in the direct-to-prescription context around denial of prescriptions runs headlong into the ethical command to “[d]eny requests for an inappropriate test, drug, or device.”Footnote 90
B. The Professional Relationship in Pharmacy Regulation
Like telehealth, telepharmacy emerged in the 2000s in response to pharmacy shortages in rural areas.Footnote 91 Telepharmacy is the practice of pharmacy by a licensed pharmacist who remotely advises and supervises a brick-and-mortar establishment that is visited by patients.Footnote 92 The exact definition of “telepharmacy” varies by state, but a useful summary stipulates that the term “refers to a brick-and-mortar pharmacy location staffed with 1 or more pharmacy technicians supervised remotely by a pharmacist at a different location who verifies prescriptions and provides counseling.”Footnote 93 In other words, it describes the licensed professional’s remote participation in supervision and advice-giving.
By contrast, internet or online pharmacies are fully remote operations. Online pharmacies may be (1) brick-and-mortar operations that have set up a website or mail order operations; either way, they are “legitimate pharmacies that require a valid prescription from a community prescriber before they dispense the medications.”Footnote 94 More problematically, they may (2) run a website to which “the patient transmits a request for particular prescription medications and the Web business mails the drugs to the patient.”Footnote 95 Since a prescriber is absent, this is the most obviously “rogue” online pharmacy example.Footnote 96 Also problematic is (3) the asynchronous model in which
patients also transmit requests for particular prescription medications. However, the patients are required to complete an online survey asking some basic questions such as weight, sex, if they have high blood pressure, and the like, or submit medical records for review. The survey or submitted records are electronically routed to a physician who has contracted with the Internet operation and usually resides in a different state from the patient. The physician reviews the survey and issues a prescription to a contracting pharmacy. The pharmacy is often a community state-licensed pharmacy in a different state from the prescriber. The pharmacy then dispenses and mails the prescription medication to the patient.Footnote 97
This is the model underlying some of the direct-to-prescription operations this article explores, though some may also include a very brief telemedicine visit.
The National Association of Boards of Pharmacy accredits online pharmacies only if they meet certain accreditation standards.Footnote 98 The professional relationship between prescriber and patient distinguishes good from bad actors: where no valid physician-patient relationship exists, federal and state law considers the resulting prescription illegal.Footnote 99 Some states prohibit
the dispensing of any prescription via the Internet if the person knows or should know that the prescriptions are not issued pursuant to a good faith examination by a prescriber. A good faith medical examination generally is interpreted as including a legitimate patient-physician relationship consisting of a physical examination and documentation on file of the patient’s medical records. Internet prescribing pursuant to a questionnaire does not qualify.Footnote 100
Importantly, again, this setup centers the professional relationship between prescriber and patient.
Compounding pharmacies provide an additional wrinkle to the direct-to-prescription marketing model, especially in the context of GLP-1 drugs. Compounding as customized pharmacy practice is unlike the industrial production of pharmaceuticals. Compounding pharmacies do not require FDA registration as drug manufacturers, and there is no FDA approval before marketing or requirement to report adverse events.Footnote 101 Recordkeeping, certification, and licensing for compounding pharmacies are subject to state law.Footnote 102 The Food, Drug, and Cosmetic Act (FDCA) prohibits pharmacies from compounding “regularly” or “in inordinate amounts” such drugs that are “essentially copies of commercially available drug products.”Footnote 103 For example, if a patient needs a certain dose of a drug that is not commercially available, or is allergic to one of the components of the commercial product, a compounding pharmacy may assemble the drug to satisfy the specific requirements for that individual patient.Footnote 104 Importantly, drugs that appear on the FDA’s drug shortage list are not considered “commercially available.”Footnote 105 Thus, they may be compounded during a shortage. According to news reports on the end of the GLP-1 shortage, “[c]ompounders are also expected to face more scrutiny from state and federal regulators, though the National Association of Boards of Pharmacy said state boards haven’t pursued action related to the issue.”Footnote 106 And, significantly, Novo Nordisk explained that its “breakup” with the platform Hims was due to “illegal mass compounding” and “deceptive marketing.”Footnote 107
III. The Regulatory Disconnect
Companies have “launched online platforms that direct users to websites run by telehealth companies, where clinicians are available to prescribe medications after a virtual consultation.”Footnote 108 Moreover, “[t]elehealth companies have also begun directly advertising pharmaceutical products on social media platforms, such as TikTok and Instagram.”Footnote 109 Beyond Anti-Kickback Statute considerations, telehealth platforms may be promoting their pharmaceutical partners’ products to consumers while omitting material risk information. FDA regulations governing prescription drug advertising impose clear disclosure obligations on pharmaceutical manufacturers, including prominent identification of side effects and contraindications.Footnote 110 These requirements, however, do not reach telehealth companies engaged in functionally similar promotional activity. Regulators could close this gap by expanding the applicable framework to cover telehealth platforms that advertise specific medications through traditional or social media channels.Footnote 111 Though outside the scope of this article, the social media advertising environment raises specific speech-based issues surrounding influencers and their lack of disclosures of product sponsorship and potential product harms.Footnote 112
The adoption of technological innovations that have made telemedicine possible also led to other forms of access to medications.Footnote 113 Pursuant to their terms and conditions, the platforms present themselves merely as conduits facilitating the professional relationship. Hims, for example, stipulates:
[w]e do not control or interfere with the practice of medicine or mental health care by the Medical Groups or any Providers, each of whom is solely responsible for directing the medical care, mental health care, and/or treatment they provide to you. By accepting this Agreement, you acknowledge and agree that Hims & Hers is not a healthcare provider and that by using the Service, you are not entering into a doctor-patient or other health care provider-patient relationship with Hims & Hers. By using the Service, you may, however, be entering into a doctor-patient or other health care provider-patient relationship with the Medical Group and/or one or more Providers. Further, we do not control or interfere with any professional service provided by the Labs and Pharmacies, each of which is solely responsible for their provision of professional services rendered via the Service.Footnote 114
Similarly, Ro’s terms of use state:
Ro does not provide any medical services, including via the Services. Rather, Ro provides a technology platform for you to access a health care provider who is employed or contracted with a Ro affiliated physician practice and obtain access to additional information, which you may or may not choose to utilize in planning your health care and wellness.Footnote 115
The contractual relationship between individual professionals and platforms is notoriously opaque which makes its legal assessment difficult. Nonetheless, this part will identify some legal and ethical guideposts to illustrate what it might look like to adopt the best version of this model by respecting and enforcing professional values with the goal of ensuring patient safety, and to avoid entrenching its worst features.
The direct-to-prescription business model ultimately depends on licensed health care providers writing prescriptions.Footnote 116 To these prescribers, the framework of professional regulation applies: professional licensing, discipline, fiduciary duties, malpractice liability, and informed consent.Footnote 117 In addition, there are distinct legal issues surrounding compounding pharmaciesFootnote 118 that came into focus in some of the more recent applications of direct-to-consumer prescribing. Pharmacists, too, have professional obligations to patients in filling prescriptions.
Licensing. The identity of the prescribers in the direct-to-prescription model seems rather obscure. According to one report, “just a handful of networks of doctors, nurse practitioners, and physician assistants are writing prescriptions for dozens of websites offering the weight loss drugs, including the compounded versions that have been the subject of conflict and debate among clinicians and industry members.”Footnote 119 As long as the telemedicine visit is conducted by a licensed professional, however, there should not be any distinctive concerns with the direct-to-prescription model. The point of requiring licensing in this context, as in all others, is to ensure the professional has the requisite knowledge to provide good advice to the patient.Footnote 120
Informed consent. The user experience varies. Some platforms in fact do
attempt due diligence before prescribing: asking patients a lengthy list of questions, conducting video intake visits, and ordering blood work to check for undiagnosed metabolic conditions before writing a prescription… . But some services provide prescriptions based on nothing more than a glorified Google form, and without careful screening, patients could easily be handed medications that harm them.Footnote 121
In light of the potentially significant side-effects, potential shortcomings are highly problematic.Footnote 122 Informed consent requires the disclosure of risks, benefits and alternatives in order to facilitate the patient’s decision;Footnote 123 this can (and should) happen in an ordinary telemedicine visit.
Malpractice liability. Platforms attempt to significantly shield themselves as well as the prescribers and pharmacies from liability.Footnote 124 Moreover, the platforms’ contracts stipulate liquidated damages.Footnote 125 Finally, the terms typically include mandatory arbitration clauses as well as waivers of class actions and jury trials.Footnote 126 This fundamentally departs from the ordinary regime of professional liability, including liability for malpractice and failure to obtain informed consent.Footnote 127 This liability framework also departs from the changes introduced by some courts in direct-to-consumer advertising.Footnote 128 Under the common law’s learned intermediary doctrine, pharmaceutical companies were able to shield themselves from products liability claims from individual patients if they sufficiently informed doctors (the learned intermediaries between themselves and the patient).Footnote 129 The individual professional was considered to be in a better position to explain the risks and benefits of a drug to the patient.Footnote 130 With the rise of direct-to-consumer advertising, however, a shift away from the central role of the prescriber occurred. Perez v. Wyeth Laboratories Inc., a 1999 decision of the New Jersey Supreme Court, was the first to hold that pharmaceutical companies engaged in direct-to-consumer advertising have an obligation to warn consumers directly.Footnote 131
With respect to limiting liability for the platforms themselves, one might imagine a scenario familiar from intermediary liability and Section 230 of the Communications Decency Act where providers are not subject to liability for third-party content they host.Footnote 132 For platforms providing direct-to-prescription marketing who want to be taken out of the liability equation, claiming analogy to providers subject to Section 230, the strongest argument is that they only provide the infrastructure to facilitate telehealth. But the platforms’ involvement with consumers goes far beyond that. They are offering the prescription medication (pay at checkout and we’ll send you the drugs),Footnote 133 rather than offering the infrastructure for a telehealth visit with a professional in order to discuss individual health needs. Moreover, the close entanglement with pharmaceutical companies looks more akin to the direct-to-consumer advertising framework and as such suggests a duty to warn with subsequent potential for liability.Footnote 134 And under the learned intermediary rule, while pharmaceutical manufacturers traditionally were not liable, the prescribing professionals were.Footnote 135 Neither the learned intermediary rule nor the direct-to-consumer framework of pharmaceutical manufacturer liability resulted in a complete exclusion of liability.
Finally, like other professionals, pharmacists can be liable for malpractice,Footnote 136 though the platforms include the pharmacies in their liability waivers.Footnote 137 Pharmacists’ duties include dispensing the correct medication and the correct strength and dosage.Footnote 138 Filling a forged prescription may be negligence per se.Footnote 139 The trend is towards a greater role of the pharmacist in health care delivery, beyond the mechanical filling of prescriptions.Footnote 140 The very limited role of pharmacy practice in the direct-to-prescription business model contradicts this trend. However, some platforms’ terms seem to allow for a greater role for pharmacies.Footnote 141 Greater involvement of pharmacy professionals might ultimately benefit patient safety in this business model, but it will make the limits on pharmacist liability more difficult to justify.
Patient expectations along these lines mirror the expectations underpinning the traditional professional relationship. One report quoted a consumer/patient as follows: “I trust pharmacists, like, they’re not going to put their license on the line to, I don’t know, create a crap product… . Why would they do that?”Footnote 142 This suggests that there is a significant regulatory gap between the framework governing ordinary professional relationships and direct-to-prescription marketing.
Fiduciary duties. Whereas the telemedicine setup focuses on professional advice-giving, the direct-to-prescription platforms set the prescribers’ fiduciary duties and the customer/patient’s best interests on a collision course. Potential conflicts of interest abound. The legal and ethical frameworks, as the following discussion will show, are in fact responsive to these new challenges and ought to be implemented accordingly.
The underlying business model, just short of promising that the customer/patient will receive the drug (as mentioned, payment is due at checkoutFootnote 143), nonetheless puts obtaining prescriptions at the center. Thus, reports suggest, for example, that “[p]roviders for online weight loss platforms that advertise prescriptions are less likely to discuss non-pharmaceutical alternatives with patients, which experts consider a best practice in obesity medicine.”Footnote 144 By design, this puts the commercial interest ahead of the patient’s interest.
Moreover, it seems unclear whether prescribers can, under the terms of their engagement with the platforms, refuse to provide a prescription.Footnote 145 Professionals’ fiduciary duties to patients demand otherwise.
Professional ethics. This also runs headlong into the ethical demands that prescriptions are “based solely on medical considerations, patient need, and reasonable expectations of effectiveness for the particular patient” and avoid “direct or indirect influence of financial interests on prescribing decisions by: declining any kind of payment or compensation from a drug company or device manufacturer for prescribing its products, including offers of indemnification.”Footnote 146 Indeed, the contractual indemnity for platforms also explicitly extends to prescribers.Footnote 147
In addition, whereas physician interactions at the beginning tend to be prioritized, follow-up visits and monitoring differs.Footnote 148 This conflicts with the AMA’s telemedicine ethics meant to ensure continuity of care.Footnote 149
***
Of course, enforcing professional regulation does not solve the entire problem. In addition to compounding pharmacies,
[a]t least a dozen websites that specialize in a class of protein-related products called peptides now list semaglutide and tirzepatide. Though they say their chemicals should only be used for lab research purposes and not for human use, individuals have been ordering from the websites to make their own injections at home. People in bodybuilding and biohacking circles have long gone to these sources for chemicals to try to build muscles and burn fat, and now, some people with clinical obesity are also turning to the websites for the first time, hoping to obtain semaglutide or tirzepatide as the original medications from Novo Nordisk and Eli Lilly remain difficult to access.Footnote 150
For these types of sources, professional regulation is an ill fit, and FDA or FTC regulation seems more appropriate.Footnote 151 Finally, there are also unlicensed, illegal distributors online that offer weight loss drugs without prescriptions.Footnote 152According to a 2023 study, over forty percent of websites selling semaglutide online without a prescription were illegal pharmacy operations.Footnote 153
Nonetheless, professional regulation can address prescribing practices, as evidence of licensing board interventions from the opioid crisis illustrates.Footnote 154 Where prescribers “remained unwilling or unable to revise their opioid prescribing behaviors,” licensing bodies took action when “prescribing practices were sufficiently egregious to catch the attention of the state medical licensing boards (MLB).”Footnote 155 Instances in which medical licensing boards revoked physicians’ licenses in the opioid prescribing context include prescribing inappropriate quantities and types of drugs and prescribing drugs without examination.Footnote 156 Ultimately, the profession must determine, as a matter of the standard of care, what constitutes acceptable prescribing practices. Licensing boards have a range of tools available, ranging from issuing letters of reprimand, requiring additional continuing education courses, or revoking prescription privileges, to the most severe intervention: excluding individuals from practicing medicine.Footnote 157 In sum, the direct-to-prescription business model must conform to the rules governing telemedicine, and its enforcement can be facilitated by licensing boards.
A final note of caution: telemedicine and online pharmacy in the United States face unique challenges due to the rollback of reproductive health care access in the wake of Dobbs v. Jackson Women’s Health Organization. Footnote 158 In this particular clinical context, political incentives and normative considerations underlying the ability to procure prescription drugs might cut in a different direction than with access to other kinds of medication. The reproductive health context also complicates the involvement of the FDA in upstream decision-making regarding drug approval.Footnote 159 Moreover, in light of potential conflicts between political controversy and medical expertise, it’s worth emphasizing that the standard of care and the corresponding content of professional advice ought to be determined by the respective professional knowledge communities and not by state legislatures.Footnote 160
IV. Conclusion
The emergence and widespread adoption of telehealth raised concerns whether expansion was driven by health objectives or market considerations.Footnote 161 Critics worried that private-sector involvement risks prioritizing commercial imperatives over patient welfare, undermining core caregiving principles and ethical integrity.Footnote 162 Commercial imperatives, the argument goes, are incompatible with patient-centered care and ethical integrity.Footnote 163 Moreover, telehealth poses new data privacy, consent, and exploitation risks. Data may increasingly be used for marketing or other non-clinical purposes, undermining informed consent, increasing surveillance risks, and weakening the provider-patient relationship. Finally, since many health-related apps and social networking platforms fall outside the purview of U.S. health care regulation, they may disseminate unvalidated content and remain exempt from the privacy and cybersecurity standards required for clinical entities, allowing vendors to lawfully demand patient agreement to broad, unrelated data uses.Footnote 164 These concerns are amplified in the direct-to-prescription business model.
Commercialization and cost-cutting by online platforms, likewise, is a double-edged sword. On the one hand, the direct-to-prescription business model responds to real shortcomings in health care delivery.Footnote 165 On the other hand, it creates openings for bad actors to exploit patients.Footnote 166 It is incumbent on the professions to defend professional knowledge and ethics to ensure provision of good professional advice.Footnote 167
The role of licensed professionals as prescribers is central to harnessing the best attributes of this model. Where professionals dispense advice, they are regulated by a legal and ethical framework.Footnote 168 Patients consult medical professionals for their specialized expertise, and they expect good advice.Footnote 169 They also expect that the professional will act with loyalty to their interests, and that the guidance provided will be accurate, comprehensive, and reliable.Footnote 170 Further, there is an expectation that the professional may be held accountable for injury resulting from negligent or erroneous advice.Footnote 171 These expectations stem from the inherent disparity in knowledge that defines the professional-patient relationship. The legal and ethical guardrails discussed respond to these expectations. The direct-to-prescription business model sits uncomfortably between the professional relationship in telemedicine and consumer-facing applications of technology. There is a significant regulatory disconnect between the framework governing ordinary professional relationships and direct-to-prescription marketing. Upholding the values underlying the professional relationship is possible in the direct-to-prescription marketing model only if that model truly incorporates the professional regulation and ethics of telemedicine.
Open access
