
[Federal Register Volume 84, Number 47 (Monday, March 11, 2019)]
[Notices]
[Pages 8728-8729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04357]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0299]


Nonprescription Naloxone Labeling Resources; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a model Drug Facts label (DFL) for nonprescription 
naloxone. Naloxone is a drug used to treat opioid overdose. FDA is 
making the DFL and supporting data available for use by applicants 
seeking approval of naloxone drug products that can be obtained without 
a prescription.

FOR FURTHER INFORMATION CONTACT: Sherry Stewart, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5494, Silver Spring, MD 20993-0002, 301-
796-9618.

SUPPLEMENTARY INFORMATION:

I. Background

    The increasing incidence of misuse and abuse of illicit and 
prescription opioids and the associated risks of addiction, overdose, 
and death have resulted in a public health crisis in the United States. 
Opioid overdose is characterized by life-threatening respiratory and 
central nervous system depression that, if not immediately

[[Page 8729]]

treated, may lead to significant morbidity and mortality. When 
administered quickly after an opioid overdose, naloxone, an opioid 
antagonist, can save lives. Naloxone is currently approved as a 
prescription drug, but it is not approved for nonprescription use. As 
part of a wide governmental effort to address the national crisis of 
opioid overdose deaths, the Agency has identified broader availability 
of naloxone, including potential nonprescription availability, as one 
means to help reduce overdose deaths.
    To support approval of a drug for nonprescription use, the sponsor 
of the drug product typically (among other things) conducts one or more 
consumer behavior studies to demonstrate that consumers would be able 
to use the drug product safely and effectively in the nonprescription 
setting without the supervision of a healthcare professional. Some 
stakeholders have identified the need to perform these studies as a 
barrier to development of a nonprescription naloxone drug product. To 
help address this concern, FDA developed a model DFL for a potential 
nonprescription naloxone drug product. The model DFL is intended to 
contain adequate information (except for individual device-specific 
information, such as how to use a particular injector or spray device, 
which would be added by the product sponsor) that a consumer would need 
to administer naloxone safely and effectively for its intended use in 
the nonprescription setting. Consumer comprehension of the model DFL 
has been iteratively tested by an independent research contractor in a 
prespecified research design involving over 700 participants across a 
wide range of potential nonprescription naloxone users. These 
participants included people who use heroin, people who use 
prescription opioids, family and friends of people who use opioids, 
adolescents, and members of the general public.
    After completion of the label comprehension study, an FDA review 
team that was not involved in the design or conduct of the study 
reviewed the study report and determined that the comprehension results 
are adequate. FDA has determined that the model DFL can be made 
publicly available so that sponsors who wish to pursue development of a 
nonprescription naloxone product can use the model DFL in their 
development program. A sponsor would need to add its device-specific 
information to the model DFL and retest that information to demonstrate 
that consumers understand the information within the context of the 
overall DFL. The model DFL comes in two versions (one for use with a 
nasal spray and one for use with an injector), but the device-specific 
instructions in each version are placeholders that have not been tested 
for comprehension or human factors performance, and sponsors will need 
to replace these placeholders with their own device-specific 
information and retest it appropriately.
    FDA strongly encourages sponsors of potential nonprescription 
naloxone drug products to request a meeting to discuss their 
development program with the Division of Nonprescription Drug Products. 
For information on sponsor meetings with FDA, sponsors can refer to the 
draft guidance for industry ``Formal Meetings Between the FDA and 
Sponsors or Applicants of PDUFA Products'' at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm590547.pdf.

II. Electronic Access

    Persons with access to the internet may obtain the model DFLs at 
https://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM629320.pdf 
and https://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM629321.pdf.

    Dated: March 6, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04357 Filed 3-8-19; 8:45 am]
BILLING CODE 4164-01-P


