FDA Takes Another Small Step to Increase Naloxone Access

October 13, 2022By Kalie E. Richardson

While COVID-19 and monkeypox may be the public health emergencies garnering much of our current attention, we have been in the midst of another declared public health emergency for nearly 5 years: the opioid crisis.  FDA recently issued a Guidance (Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency) that is narrowly tailored, but it is intended to increase access to naloxone—a prescription drug critical in the rapid treatment of opioid overdoses—by harm reduction programs that often serve the most at-risk populations.  In light of the urgent public health need to facilitate and expedite access to naloxone, FDA is implementing this Guidance immediately without prior public comment.

As background, naloxone hydrochloride (“naloxone”) is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdoses and is available in three FDA-approved forms (injectable, auto-injector, and nasal spray).  Naloxone is a prescription drug, but unlike some other prescription drugs used in the treatment of opioid addiction such as buprenorphine, it is not a controlled substance.  Most states have some form of naloxone standing order that allows a healthcare provider to write a prescription that covers a large group of people rather than just an individual patient.  For example, the Maryland standing order allows all Maryland licensed pharmacists to dispense naloxone, including any necessary sup​​plies for administration (e.g., syringes), to any individual without a patient-specific prescription.

Despite the state standing orders, “harm reduction programs” that provide products and services to individuals at risk of experiencing an opioid overdose or those who might respond to an overdose, still face logistical difficulties in acquiring naloxone, as was the subject of a March 2022 workshop on Naloxone Access hosted by the Reagan-Udall Foundation for the FDA.  Because naloxone is a prescription drug, its distribution is subject to the requirements of the Drug Supply Chain Security Act (DSCSA).  One of the DSCSA requirements is that the trading partners of a manufacturer, wholesale distributor, repackager, or dispenser must be “authorized,” which generally requires they hold a valid FDA registration or applicable state license.  Harm reduction programs typically aren’t medical clinics or pharmacies and would not hold any state licenses that would allow them to purchase prescription drugs; although, at least one state (Rhode Island) has created a licensure category for harm reduction centers.   As described by Dr. Nabarun Dasgupta in the Naloxone Access workshop, wholesale distributors often treat harm reduction programs like pharmacies because naloxone is a prescription drug.  Because many harm reduction programs don’t have a pharmacy or medical license, wholesale distributors may determine that they are ineligible to purchase prescription drugs.

By statute, certain activities are automatically excluded from particular DSCSA requirements upon the declaration of a public health emergency under section 319 of the PHS Act.  Specifically, the distribution of a product for emergency medical reasons (including a public health emergency declaration), is exempted from the definition of a “transaction” and excluded from the definition of “wholesale distribution” under the DSCSA.  The purpose of the recent Guidance is to clarify FDA’s interpretation that the exemption and exclusion apply to the distribution of FDA-approved naloxone products to harm reduction programs and to harm reduction suppliers.  The Guidance is intentionally narrow and only remains in effect for the duration of the declared public health emergency which currently must be renewed by the HHS Secretary every 90 days.

During the declared opioid public health emergency, trading partners engaged in the distribution of FDA-approved naloxone products to harm reduction programs and harm reduction suppliers, and the harm reduction programs and harm reduction suppliers obtaining naloxone through such distribution, are not required to comply with the DSCSA product tracing and product identification requirements that are triggered by a “transaction.”  Additionally, FDA does not intend to take enforcement action against trading partners for the distribution of naloxone to harm reduction suppliers and harm reduction programs that are not “authorized trading partners.”

While it is clear that FDA intends to provide clarity and increase access to naloxone for harm reduction programs in particular, we see two potential impediments that can hopefully be easily resolved:

  1. Wholesale distributors that sell naloxone to harm reduction programs—particularly the individuals responsible for onboarding new customers—need to be aware of the DSCSA exemption and exclusion provided by the Guidance or else the administrative roadblocks described by Dr. Dasgupta will persist.
  2. It may not be clear to supply chain stakeholders which entities may be considered “harm reduction programs” for the purposes of this Guidance. While certain states do define “harm reduction programs” (e.g., West Virginia), there is no such definition in FDA regulations or in the DSCSA.  When ordering from a new supplier, harm reduction programs should be prepared to provide an explanation of how then intend to dispense or otherwise use the products.

We note that the clearest (but certainly not fastest) way to reduce barriers to naloxone access for harm reduction programs and other stakeholders is for naloxone to be available as an OTC drug, which remains an ongoing effort and is well beyond the scope of the particular Guidance.  If naloxone were available for OTC use, the patchwork of state standing orders would no longer be necessary and the transactions would not be within the scope of the DSCSA, which only applies to the distribution of prescription drug products.