DEA Intensifies Scrutiny on Online Prescribing of Controlled Substances, Including Implications for GLP-1 Medications

Overview of DEA Enforcement Trends

The Drug Enforcement Administration (DEA) has signaled a significant shift towards increased enforcement and scrutiny regarding the online prescribing of controlled substances, particularly as the telehealth flexibilities enacted during the COVID-19 Public Health Emergency (PHE) have begun to sunset. This renewed focus emphasizes the importance of a legitimate medical purpose and a bona fide patient-practitioner relationship for all prescriptions, especially for controlled substances. While the immediate focus is on controlled substances, this trend also has indirect implications for other high-demand medications, such as compounded GLP-1s, which are not controlled substances but are often prescribed via telehealth for weight management.

The DEA's historical stance, codified in the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, generally requires an in-person medical evaluation before a controlled substance can be prescribed via the internet. The PHE waivers temporarily allowed for prescribing controlled substances via telehealth without a prior in-person visit. However, as these waivers expired, the DEA has been working to finalize new rules, with an interim period during which some flexibilities were extended. The overarching message from the DEA is clear: the agency is returning to a more stringent enforcement posture, targeting practices that exploit telehealth for illicit drug distribution or unsafe prescribing.

The Ryan Haight Act and Telehealth

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (21 U.S.C. § 829(e)) was enacted to combat the proliferation of rogue online pharmacies. Its core tenet is that a controlled substance prescription issued via the internet is not valid unless the practitioner has conducted at least one in-person medical evaluation of the patient. There are specific exceptions to this rule, such as when the patient is being treated in a hospital, or when the practitioner is acting as a covering physician, or under a specific DEA-issued waiver. The PHE waivers provided a temporary, broad exception to this in-person requirement for controlled substances prescribed via telehealth.

With the expiration of the PHE, the DEA initially proposed new rules that would have reinstated the in-person requirement for most controlled substances prescribed via telehealth. Following significant public comment, the DEA issued a temporary rule extending some of the PHE flexibilities until November 11, 2023, and then further extended them until December 31, 2024, to allow for a more thorough review of public comments and the development of a permanent rule. Despite these extensions, the DEA has consistently reiterated its commitment to preventing diversion and ensuring patient safety, indicating that any permanent rule will likely include robust safeguards.

Key takeaways from DEA guidance and enforcement trends:

• Legitimate Medical Purpose: Every prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. This is a foundational principle of controlled substance prescribing.
• Bona Fide Patient-Practitioner Relationship: The DEA emphasizes that a meaningful relationship, often involving a comprehensive medical evaluation and ongoing care, is crucial. This goes beyond a brief online questionnaire or a single telehealth visit without adequate follow-up.
• Risk of Diversion: The DEA is particularly concerned about controlled substances with a high potential for abuse and diversion. Practices that facilitate easy access to these medications without proper safeguards are high-risk targets.
• State Law Compliance: Federal law sets a baseline, but practitioners must also comply with all applicable state laws and regulations regarding telehealth and controlled substance prescribing, which can be more restrictive.

Implications for GLP-1 Medications (Semaglutide, Tirzepatide)

While GLP-1 receptor agonists like semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound) are not controlled substances, their rapid rise in popularity for weight management, particularly in compounded forms, has drawn attention from regulatory bodies, including the FDA and state pharmacy boards. The DEA's enforcement posture on controlled substances can indirectly impact practices prescribing these medications for several reasons:

1. Broader Scrutiny of Telehealth Practices: If a telehealth platform or clinic is found to be engaging in questionable prescribing practices for controlled substances, it can trigger a broader investigation into all of its prescribing activities, including non-controlled medications like GLP-1s.
2. Legitimate Medical Purpose: The principle of prescribing for a legitimate medical purpose applies to all medications. Prescribing GLP-1s off-label or without proper medical evaluation, patient monitoring, and adherence to clinical guidelines could be viewed as unprofessional conduct, even if the medication itself is not controlled. This could lead to state medical board actions, which often cooperate with federal agencies.
3. Compounding Concerns: The FDA has issued warnings regarding compounded versions of GLP-1s, citing concerns about safety, efficacy, and the legality of compounding when FDA-approved versions are available. While not directly a DEA issue, these concerns contribute to a regulatory environment of heightened scrutiny for practices involved in their prescription and administration. The DEA's focus on legitimate pharmacies and proper drug handling can extend to how compounded medications are sourced and dispensed.
4. Misleading Marketing and Fraud: Practices that engage in aggressive or misleading marketing for GLP-1s, or that offer them without proper medical oversight, could face scrutiny from the Federal Trade Commission (FTC) or state consumer protection agencies. Such investigations can sometimes overlap with or trigger inquiries from other federal agencies if fraudulent billing or other illicit activities are suspected.

Enforcement Actions and Trends

The DEA, often in conjunction with the Department of Justice (DOJ) and state law enforcement, has a history of pursuing cases against healthcare providers and companies involved in the unlawful distribution of controlled substances via the internet. Recent trends indicate a continued emphasis on:

• Data Analytics: Utilizing Prescription Drug Monitoring Programs (PDMPs) and other data sources to identify unusual prescribing patterns.
• Undercover Operations: Employing undercover agents to pose as patients to test the legitimacy of online prescribing practices.
• Collaboration: Working closely with state medical boards, pharmacy boards, and other federal agencies to build comprehensive cases.
• Focus on High-Volume Prescribers: Targeting platforms or individual practitioners with unusually high volumes of controlled substance prescriptions, especially those without established patient relationships.

These enforcement actions can result in severe penalties, including loss of DEA registration, professional license revocation, significant fines, and criminal charges for both individuals and corporate entities.

Conclusion

The DEA's ongoing efforts to regulate the online prescribing of controlled substances, coupled with broader regulatory attention on high-demand medications like compounded GLP-1s, underscore a critical need for vigilance and robust compliance programs within the healthcare industry. Telehealth providers, medspas, and other practices must ensure their operations strictly adhere to federal and state laws, prioritize patient safety, and maintain the highest standards of professional conduct to mitigate regulatory risk.

References

• Drug Enforcement Administration (DEA) Practitioner's Manual: This comprehensive guide outlines the responsibilities of practitioners prescribing controlled substances.
  • https://www.deadiversion.usdoj.gov/pubs1/manuals/pract/pract_manual.pdf
• DEA Telemedicine webpage: Provides updates and guidance regarding telemedicine prescribing of controlled substances.
  • https://www.deadiversion.usdoj.gov/telemedicine/index.html
• FDA Information about Compounded Semaglutide: Alerts and information regarding compounded GLP-1 medications.
  • https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss