Alan J. Arville and Spreeha Choudhury, attorneys in the Health Care & Life Sciences practice, in the firm’s Washington, DC, and Newark offices, respectively, co-authored an article in Pharmaceutical Executive, titled "Navigating Pharmacy Models and Regulatory Pitfalls When Launching Direct-to-Consumer Programs."
Following is an excerpt:
President Trump’s May 2025 Executive Order on “Most Favored Nation” (MFN) pricing placed new pressure on drug manufacturers, requiring them to match lower drug prices paid by patients in other developed countries. Two months later, the administration escalated its demands, sending letters to 17 of the largest manufacturers insisting on binding commitments to cut U.S. drug costs, expand Medicaid discounts, and, most notably, roll out direct-to-consumer (DTC) programs for high-volume drugs.
Even before these directives, manufacturers had already begun developing DTC programs: branded cash-based platforms that sell prescription medicines directly to patients, bypassing traditional “middlemen”. Manufacturers point to these programs as a way to improve patient experience and access to medicines by offering lower pricing when insurance coverage falls short.
However, launching DTC models is not a straightforward task. It requires navigating regulatory and licensing rules, especially those governing manufacturer relationships with consumers, prescribers and pharmacies. For this reason, despite the administration’s push for immediate action, the infrastructure needed for successful DTC programs cannot be built overnight.
Key components of a DTC program
At first glance, selling prescription drugs directly to patients may appear simple. However, in practice, it is a highly regulated activity that will likely require at least one pharmacy to dispense drugs. It will also, of course, require physicians and consumers to be aware of the availability of the DTC program. Manufacturers may also wish to make consumers aware (e.g., via the dedicated DTC program website) of providers with the appropriate specialty to assess whether the product should be prescribed, including, where appropriate, telemedicine providers. …
