News & Events

FDA Statement

Statement from FDA Commissioner Scott Gottlieb, M.D., on new strategies for addressing the crisis of opioid addiction through innovation in packaging, storage and disposal

For Immediate Release

October 30, 2017

Statement

One of my highest priorities as the Commissioner of the U.S. Food and Drug Administration is to take whatever steps we can to reduce the scope and human tragedy created by the epidemic of addiction to opioids. At the FDA, we’re especially focused on helping more patients struggling with current addiction receive appropriate care with proven treatments and reducing new cases of addiction. Lowering the rate of new addiction means also reducing overall exposure to opioids to prevent more people from becoming addicted to these drugs in the first place. In the setting of the President’s declaration of a national public health emergency related to the crisis, I’m reaffirming the FDA’s commitment to work across the full range of its authorities to address this epidemic.

This includes looking for new ways to work more creatively with public and private partners and identifying solutions – no matter how big or small – that will reduce exposure to opioid drugs and help make sure that only properly indicated patients are prescribed opioids. When prescriptions are initially written, they should be for durations of use that comport with the clinical circumstance.

To achieve these goals, one area we’ve committed to exploring further is how opioid drug products are packaged, stored and ultimately – when no longer needed – discarded. The FDA is committed to exploring our existing authorities to find new and impactful ways of regulating these product features to improve patient safety.

There are a number of new steps the FDA is considering. For example, it’s possible that a defined, short-term supply of medication could be packaged in a manner that limits the number of pills dispensed. This might be achieved, for example, through a blister pack that has a defined duration of use that might be for only a limited number of doses. Other packaging innovations could make it easier to track the number of doses that have been taken. Still other options could work to improve storage and encourage prompt disposal to reduce the available supply and reduce the risk for third-party access, such as a child accidentally ingesting pills they found in a medicine cabinet. There are also technologies that could allow health care providers, pharmacists or family members to monitor patient use of prescription opioids.

The FDA has already been working on several efforts to explore solutions in this area. The Opioid Policy Steering Committee that we established in May is considering, among other things, what steps the agency can or should take with respect to packaging (e.g., unit of use) to facilitate appropriate opioid analgesic prescribing practice. We also have created an internal task force that’s conducting additional research to inform our policies and decision-making in these areas. Additionally, FDA staff are engaging with other experts to explore this important topic, including participating in a workshop disclaimer icon convened by the Duke-Margolis Center for Health Policy that generated additional ideas for further consideration.

This is a topic worthy of significant attention and consideration. That is why today we announced a two-day public workshop, which will take place on Dec. 11-12, 2017, to advance this issue by working with a broad set of federal, state, and other stakeholders who are also addressing the challenges of balancing pain management with the critical need to address the opioid epidemic. Our goals at this scientific workshop encompass three key areas. First, we need to define the specific problems that these types of packaging and disposal solutions can help address. Second, we want to more clearly define the guiding principles that the scientific community should consider in designing product features that achieve these possible solutions. Finally, we’ll better define the types of data needed in order to evaluate how these solutions are working.

We believe that innovation in packaging, storage, and disposal could have a meaningful impact on preventing or deterring misuse, abuse, or inappropriate access to prescription opioids – especially when coupled with additional efforts that the FDA and others are undertaking to reduce the scope of the opioid epidemic. We look forward to the two-day meeting and the opportunity to discuss the potential for new, innovative tools and strategies the FDA can take to address the public health crisis of opioid addiction.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Page Last Updated: 10/30/2017
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