By Vrushab Gowda
The burgeoning industry of drone-enabled pharmaceutical delivery offers a number of advantages over its low-tech forebears, not least including patient convenience.
It minimizes exposure to infection and potentially protects patient anonymity, all while reducing wait times relative to in-person or traditional mail-order pharmacies. Additionally, drones can broaden access to medications in resource-poor areas, including locations with low densities of health care facilities, and those where underdeveloped transportation links hinder ground delivery.
However, drone delivery of pharmaceuticals enters into a nebulous legal environment, sitting as it does at the intersection of healthcare, privacy law, and aviation regulation. It is, moreover, a dynamic landscape, which continues to evolve with new federal rules, judicial decisions, and corporate practices.
Dawn of the Drones
Light drones, or unmanned aerial systems (UAS) as they are formally known, have been transformed from mere novelty to industrial implement in a remarkably short span. They are increasingly seeing deployment across a range of commercial settings; drone-based distribution is expected to drive a global market estimated to grow by nearly 45% annually through 2030.
Pharmaceutical delivery is no exception. While UPS, Amazon, and other well-established players in the supply chain sector have been quick to pioneer this new technology, medical centers themselves are now beginning to spearhead drone delivery efforts.
The Evolving Role of the FAA
Small drones are generally governed by “Part 107,” the colloquial reference to the relevant portion of CFR Title 14 administered by the Federal Aviation Administration (FAA). Should they conform to a set of defined operating and user regulations, UAS fall into a variant of enforcement discretion exempting them from more detailed regulatory obligations, such as design inspections. However, Part 107’s provisions are quite restrictive; they bar drones from interstate transportation, flight above 100 miles per hour or higher than 400 feet in altitude, weight exceeding 55 pounds inclusive of payload and fuel, and operations beyond pilot line of sight, to list a few. Exceptions are afforded on a case-by-case basis through either an extensive waiver process or application for Part 135 air carrier certification, which is not currently configured for UAS.
The FAA has displayed a willingness to gradually relax these provisions over the past five years. In guidance, it indicated that autonomous drone operations are permissible, provided that the remote pilot retain the ability to control the aircraft. The FAA has also recently moved to permit the wider use of UAS through regulatory innovations, shifting its stance of broad enforcement discretion to consider characteristics of a drone itself. More specifically, it now seeks to articulate airworthiness criteria for small UAS according to risk-stratified guidelines, treating them as a distinct class of aircraft for which type certifications may be issued. This, in turn, would open the door to less confining criteria than those set forth in Part 107. Drones may face further constraints from state and local governments, although a 2018 District of Massachusetts decision found broad federal preemption in UAS regulation.
Radio Silence, For Now
Drone operations present additional concerns for health regulators, although courts and the public health apparatus have yet to pronounce upon the issue with granularity.
For one, the security of the onboard pharmaceuticals — not to mention patient data and the drone itself — is a key consideration. Maintaining their integrity may in many cases prove a difficult task, particularly for biologics like insulin and vaccines. They are sensitive to temperature, humidity, and vibration, and must be kept within precise ranges; unprotected, all of these parameters may vary over the course of the flight. Moreover, installing onboard environmental systems would contribute to the drone’s overall weight, not only reducing its overall payload capacity but also potentially risking noncompliance with Part 107.
Separately, drones may convey sensitive protected health information physically imprinted on their cargo or electronically transmitted in flight to recipients on the ground. Securing this data is paramount, just as it is with mail-order prescriptions and telemedicine care. This underscores the essential need for additional safeguards to uphold confidentiality, verify that the appropriate end users are adequately informed, and ensure compliance with HIPAA.
There is the further issue of determining the type of medications (or tissues) that may be permissibly transported by UAS. Neither the Drug Enforcement Agency (DEA) nor the Food and Drug Administration (FDA) have spoken on this matter (although narcotraffickers are increasingly integrating drones into their distribution networks); the risk of loss, mistaken delivery, or diversion of controlled substances looms large in the background.
Regulatory oversight is divided across multiple federal agencies, ranging from the FAA, FDA, and DEA, as mentioned above, to the Federal Communications Commission (FCC), Federal Trade Commission (FTC), and multiple offices within the Department of Health and Human Services (HHS), among others. With this level of jurisdictional fragmentation, extensive consultation among these disparate authorities is vital in formulating a coherent national regulatory regime. The governance void opens a niche for state boards of pharmacy to occupy. They can establish guidelines for the proper exercise of drone-enabled pharmaceutical delivery, at least to the extent it is utilized by licensed pharmacists. Guidelines may limit the transport of controlled substances or those at high risk of abuse, mandate the absence of personal identifiers on drug labels, and establish a venue for pharmacists to provide remote consultation to recipients as necessary. This state board-based approach would bring some measure of clarity to the UAS space, but can only serve as an interim solution pending the development of a rational federal scheme.