Friday , January 27 2023

Statement by FDA Commissioner Scott Gottlieb, MD on new unprecedented efforts to support the development of over-the-counter naloxone to help reduce opiate overdose deaths


– The number of overdose deaths involving prescription and illicit opioids more than doubled over the last seven years to nearly 48,000 in 2017, it is critical that we continue to address this tragedy on all fronts. This includes new ways to increase the availability of naloxone, a medicine used to treat opioid overdose.

When someone overdoses an opioid, the person may lose consciousness, and breathing may become superficial or can stop. This can quickly lead to death if there is no medical intervention.

However, in the case of rapid administration of naloxone, it can counteract the effects of overdose, usually within minutes. While the person administering naloxone should also require immediate medical attention to the patient, the conclusion is that higher availability of naloxone and rapid administration can save lives.

Naloxone is a critical drug that helps reduce deaths from opioid overdoses. Prevention and treatment of opiate overdose is an urgent priority. The increased availability of naloxone for the emergency treatment of overdose is an important step. A potential way to improve access to naloxone is to make available for sale outside OTC. Fox-approved versions of naloxone currently require a prescription, which may be a barrier to people who are not under the care of a doctor, or may be ashamed or even afraid of admitting to substance abuse problems. Taking advantage of the wide availability of naloxone, for example as an approved product for OTC, is an important breakthrough in public health and a need that we have worked with the FDA.

Although FDA-approved formulations of naloxone prescription have instructions for use in product labeling, they do not have the Drog Consumer Invoice (DFL) label, which is required for OTC medicines. Before submitting a new drug application or a supplement for an OTC product, companies need to develop a DFL and conduct studies to show that consumers can understand how to use the product without the supervision of a physician. Some stakeholders have identified the need to carry out these studies as a barrier to the development of OTC naloxone products.

To encourage drug companies to enter the OTC market and increase access to naloxone, the FDA has taken an unprecedented step: we have developed a DFL model with easy-to-understand pictograms about how to use the drug. We also conducted labels to make sure the instructions were easy to follow.

This is the first time the FDA has proactively developed and tested a DFL for a drug to support the development of an OTC product. We designed, tested and proactively validated the essential labeling requirements needed to approve an OTC version of naloxone and make it available to patients. One of the key components for OTC availability is now in place. In short, we created the label of the model that sponsors can use to get approval for naloxone OTC and to increase their access. This action was part of our wider commitment to tackling the opiate crisis.

Today we announce the results of our work, including the posting of two DFL models (one for nasal spray and one for use with an autoinjector) and FDA support. These efforts should start developing OTC naloxone products to promote wider access to this drug. The DFL model contains the information (with the exception of specific product-specific information) that the consumer has to safely and effectively administer.

During this time, without FY19 granting to the FDA, we focused on ensuring continued critical aspects of our work to the extent permitted by law. Currently, for products (such as naloxone) that are covered by a user fee program, our analysis of existing applications for medical products and the associated policy development for our review are funded by limited tax transfer limits by the user. We will continue to update the public about how we approach our business when we overdraft.

Consumer understanding of the DFL model has been iteratively tested by an independent research entrepreneur in a prespecified research project that involved over 700 participants from a wide range of potential users of naloxone OTC. These included people using heroin; people using prescription opioids; family and friends of opioid users; teenagers; and the general public. An FDA evaluation team that was not directly involved in the study independently reviewed the study report and determined that the results of the agreement were satisfactory. Overall, the study demonstrated that the DFL model was well understood by consumers and is acceptable for use by manufacturers in support of their OTC naloxone development programs. Using this information, naloxone manufacturers can now focus their efforts on end-label assay tests on how consumers understand product-specific information that has not already been tested in the DFL model. I personally require companies to take note of this path that the FDA has opened for them and come to the agency with requests as soon as possible.

The DFL comes in two versions. One is used with a nasal spray and one for use with a self-injector. But the specific instructions for each version are substitutes that have not been tested by the FDA for the understanding or performance of human factors. Sponsors can replace these substitutes with their own product-specific information and can test if necessary. In addition to this product-specific information, the DFL otherwise contains all the essential information required for an untrained participant to administer naloxone. When designing the DFL, the FDA team sought contributions from more addictive care community stakeholders as well as from FDA's internal experts to streamline DFL to contain only the most important information to be easy understood in an emergency. We are grateful to hundreds of study participants who have helped us see this DFL through their eyes, which has allowed us to refine DFL several times until we reach a final version. These researchers have allowed these efforts.

This work is based on our ongoing efforts to get this drug that saves life in the hands of those who need it the most. In addition to the approval of injectable naloxone for use in a health care environment and both autoinjector prescription and intranasal forms of naloxone that facilitates the use of laypersons, we also launched the guidance project to advance the development of the generic spray spray nasal naloxone hydrochloride.

In addition, we have organized a two-day consultative committee meeting last month to request information and advice on strategies to increase the availability of naloxone products for use in the community. We have asked our external counselors from the FDA's anesthetic and analgesic drug and drug safety and risk management advisory committees to consider various options for increasing access to naloxone.

As part of HHS's ongoing efforts to fight the opiate crisis and expand the use of naloxone, in April 2017, the Department announced its 5-point strategy to combat the opiate crisis. These efforts include: improving services for prevention, treatment and recovery of addiction; better data; better pain management; better targeting of overdose reversal medications; and better research. In April 2018, general surgeon VADM Jerome Adams issued a council to encourage more individuals, including family, friends, and those who are personally exposed to an overdose of opioids to carry naloxone. In December 2018, Adm. Brett P. Giroir, MD, Deputy Health Secretary and chief opioid policy counselor, has launched guidelines for health care providers and patients detailing how naloxone can help save lives.

We take many steps to improve the availability of naloxone products and we are committed to working with other federal, state and local officials; healthcare providers; patients; and communities across the country to combat the impetus of human and economic economic growth generated by opiate abuse and addiction.

For more information:
FDA: Information on Naloxone

The FDA, an agency in the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary medicines, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety and security of our country's food supply, cosmetics, food supplements, electronic radiation products, and the regulation of tobacco products.

Media Investigations: Sarah Peddicord, 301-796-2805, [email protected]
Questions for consumers: 888-INFO-FDA

SOURCE US Food and Drug Administration

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