On October 24, 2018, President Trump signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the “SUPPORT Act”) into law. The far-reaching legislation is the product of bipartisan, bicameral efforts to combat the opioid crisis, which has been a key policy focus of the Trump Administration. The provisions of the SUPPORT Act are wide-ranging, impacting those across the healthcare industry and pharmaceutical supply chain. The full text of the new law is available here. Below, we highlight a selection of provisions with the potential to impact manufacturers of FDA-approved opioid analgesics, some of which FDA has already signaled an intention to leverage.
- Notification, non-distribution, and recall of controlled substances. Section 3012 of the SUPPORT Act, which took effect immediately upon enactment, provides FDA with the authority to issue an order requiring manufacturers, importers, distributors, or pharmacists who distribute a controlled substance to immediately cease distribution of such controlled substance when FDA determines there to be a “reasonable probability that a controlled substance would cause serious adverse health consequences or death.” The party who receives such an order is entitled to an informal hearing to be held not later than 10 days after the date of issuance of the order. During this hearing, it will be determined whether adequate evidence exists to continue the order to cease distribution and whether to amend the order to further require a mandatory recall of the controlled substance and to notify the appropriate persons of such a recall. This provision further authorizes refusal of admission into the U.S. of a controlled substance that is subject to a recall order.
- Postmarket studies and safety labeling changes related to potential reductions in effectiveness. Section 3041 of the SUPPORT Act clarifies FDA’s authority in certain circumstances to require postmarket studies or clinical trials to assess the potential reduction in effectiveness of a drug, such as an opioid, and how such reduction in effectiveness could result in a change to the benefits of the drug and the risks to the patient. The provision also amends the Federal Food, Drug, and Cosmetic Act to grant FDA authority to require labeling changes related to new reduced effectiveness information. FDA is required to issue a guidance within one year after the enactment of the SUPPORT Act that will address the circumstances under which FDA may require postmarket studies or clinical trials and safety labeling changes related to the use of controlled substances for acute or chronic pain.
- Evidence-based opioid analgesic prescribing guidelines. Section 3002 of the SUPPORT Act requires FDA to develop, with public input, evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain for the therapeutic areas where such guidelines do not exist. Notably, in August 2018, FDA announced that it had awarded a contract to the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of evidence-based guidelines for opioid analgesic prescribing for acute pain resulting from specific conditions or procedures. Such prescribing guidelines may be utilized to inform FDA’s implementation of its packaging authorities described below. On November 13, 2018, in response to a question from a committee member during a NASEM committee meeting, FDA Commissioner Gottlieb clarified that he did not envision the agency prescriptively requiring healthcare providers to adopt the NASEM-developed guidelines, but would leave it to providers to incorporate these evidence-based guidelines into practice once issued.
- Safety-enhancing packaging and disposal features. Section 3032 of the SUPPORT Act, which took effect immediately upon enactment, clarifies FDA’s authority to require, as part of a risk evaluation mitigation strategy (REMS), drug manufacturers to make certain drugs available for dispensing in unit dose packaging, such as blister packs. Additionally, this section clarifies FDA’s authority to require manufacturers to provide certain patients with safe disposal packaging or safe disposal systems for purposes of rendering unused drugs nonretrievable. This section further requires FDA to permit manufacturers of generic drugs approved under an abbreviated new drug application (ANDA) to use packaging systems and safe disposal packaging or safe disposals systems that are different from those required for the applicable listed drug.
Significantly, FDA has already signaled an intent to leverage the packaging provision of the SUPPORT Act. On October 24, 2018, FDA released a statement from FDA Commissioner Gottlieb describing how the SUPPORT Act will assist the Agency in “more forcefully” addressing the opioid crisis. The statement highlights that decreasing exposure to opioids as a way to lower the rate of new addiction continues to be a key priority for the Agency. The statement further describes FDA’s vision of leveraging the SUPPORT Act’s packaging provision, coupled with new evidence-based opioid prescribing guidelines as well as prescriber education programs, to discourage the use of 30-day prescriptions and other practices that contribute to the excess supply of opioid analgesics.
Dr. Gottlieb discussed the issue of excess supply at length in an earlier October 18, 2018 interview. Specifically, Dr. Gottlieb signaled that mandating blister packaging will be “the first thing” the FDA is going to do. Further, Dr. Gottlieb described a vision for utilizing tiered mandates for prescriber education, where prescribers who write a 30-day prescription or otherwise prescribe long durations of use would be required to undergo mandatory education, while those who write shorter-term prescriptions would not. While Dr. Gottlieb has previously expressed interest in tiered mandates for prescriber education, the most recent September 2018 update to the Opioid Analgesic REMS did not require education.
We expect to see continued dialogue between FDA and its stakeholders across the healthcare continuum on this matter as FDA implements the authorities provided by the new law and continues to evolve its policies to address the opioid crisis. Notably, on November 13, 2018, FDA Commissioner Gottlieb stated that additional opioid epidemic related policy objectives and goals will be announced in the agency’s 2019 Policy Roadmap, which is expected to be released in early January 2019.