The US Senate has passed The Opioid Crisis Response Act of 2018, bipartisan legislation that included over 70 proposals from five Senate committees to address the challenge of opioid misuse in the US. The bill, passed in a vote of 99-1, will now have to be reconciled and combined with the US House of Representative’s bill on this issue, which was passed in June 2018. The Senate legislation contains several measures relating to the packaging and distribution of opioids and clarifies the regulatory pathways to encourage development of new non-addictive and non-opioid pain products.

In all, the Senate legislation authorizes appropriations totaling an estimated $7.9 billion for the Centers for Disease Control and Prevention, the Department of Health and Human Services (HHS), and other agencies within HHS for programs to address the opioid epidemic in the US, according to estimates from the Congressional Budget Office.

The Senate legislation includes several provisions relating to the packaging of opioids. The bill authorizes the US Food and Drug Administration (FDA) to require drug manufacturers to package opioids and certain other drugs in blister packs, such as a in three or seven-day supply. The measure is designed to make it simpler for a doctor to write a prescription for a smaller number of opioids, easier for pharmacists to fill, and to help prevent overprescribing and diversion of unused medicine, for example, preventing unused medicines from being sold or abused. The Senate bill also requires drug manufacturers to provide a safe disposable packaging system or safe disposal systems for purposes of rendering unused drugs non-retrievable.

Additionally, the legislation clarifies the development and regulatory pathways for new non-addictive and non-opioid pain products. This includes expedited pathways that help medical-product manufacturers navigate the FDA by clarifying the FDA’s interpretation of how the qualification parameters for expedited pathways, such as breakthrough designation and accelerated approval, apply to non-opioid pain treatments. The bill also requires the FDA to provide guidance on how the agency will consider the risks and benefits of drugs that have a potential to be misused or abused. To help advance the development of products that can reduce, replace, or avoid patients’ use of opioids to control pain, the bill directs the FDA to clarify requirements for opioid-sparing data to be used in the label that a medicine is as effective at controlling pain and able to reduce, replace, or avoid the amount of opioids a patient needs to control pain. To help medical product manufacturers design clinical trials for innovative non-addictive pain treatments, the bill requires the FDA to provide guidance on the appropriate use of pain endpoints across review divisions. The bill also provides FDA’s post-market authorities for drugs, such as opioids, which may have reduced efficacy over time, by modifying the definition of an adverse drug experience to include such situations.

The Senate legislation further provides measures to improve detection and seizure of illegal drugs, such as fentanyl, by strengthening coordination activities between the FDA and the US Customs and Border Protection (CBP). It also requires the United States Postal Service to update its facilities to allow real-time information sharing with the Department of Homeland Security about the origin and destination of incoming goods. This would ensure FDA and CBP have the detection technology and testing equipment that allows near real-time data sharing, facility and physical infrastructure upgrades, and laboratory capacity.

The Senate legislation also has several measures to support recovery and treatment, such as support for recovery centers that will provide housing, job training, and medically supervised withdrawal management. Additionally, the legislation includes support for state efforts to improve plans of safe care for children born to mothers battling addiction as well as provisions to develop a taskforce and grants to help support trauma-informed care programs, and increase access to mental health care for children.

The Senate legislation will now have to be reconciled with the US House of Representative’s legislation, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (H.R. 6), which passed in June 2018.  by a vote of 396-14. US Senate Committee on Health, Education, Labor, and Pensions Chairman Lamar Alexander (R-TN), who was a sponsor of the Senate legislation, said he is “already working to combine the Senate and House-passed bills into an even stronger law to fight the nation’s worst public health crisis, and there is a bipartisan sense of urgency to send the bill to the President quickly,” in a September 17, 2018 speech.

H.R. 6 was created to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes. The bill is a combination of 58 individual bills previously approved by the House. The bill includes legislative priorities that would, among other issues, support emergency treatment for overdoses, improve treatment and recovery services, and strengthen education and training for healthcare professionals.

In a separate development, the FDA took new steps as part of its broader efforts to address the opioid crisis by approving the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). This new plan includes several measures to help better communicate the serious risks about the use of opioid pain medications to patients and healthcare professionals. This expanded REMS now, for the first time, applies to immediate-release (IR) opioid analgesics intended for use in an outpatient setting. The new REMS also applies to the extended-release and long-acting opioid analgesics, which have been subject to a REMS since 2012.

The REMS program requires, for the first time, that training be made available to healthcare providers who are involved in the management of patients with pain, and not only to prescribers. For example, the training provided through the REMS must be made available to nurses and pharmacists. The new REMS also requires that the education cover broader information about appropriate pain management, including alternatives to opioids for the treatment of pain. The agency is also approving new product labeling containing information about the health care provider education available through the new REMS.

Source: Office of Senator Lamar Alexander, Congressional Budget Office, and FDA