The SUPPORT for Patients and Communities Act (P.L. 115-271): Food and Drug Administration and Controlled Substance Provisions

Summary

On October 24, 2018, President Trump signed into law H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (P.L. 115-271; the SUPPORT for Patients and Communities Act, or the SUPPORT Act).

The SUPPORT Act is a sweeping measure designed to address widespread overprescribing and abuse of opioids in the United States. The act includes provisions involving law enforcement, public health, and health care financing and coverage. Broadly, the legislation imposes tighter oversight of opioid production and distribution; imposes additional reporting and safeguards to address fraud; and limits coverage of prescription opioids, while expanding coverage of and access to opioid addiction treatment services. The bill also authorizes a number of programs that seek to expand consumer education on opioid use and train additional providers to treat individuals with opioid use disorders.

The SUPPORT Act builds on recent efforts by the federal government to address the opioid epidemic, including the Comprehensive Addiction and Recovery Act of 2016 (CARA; P.L. 114-198) and the 21st Century Cures Act (Cures Act; P.L. 114-255). CARA addressed substance use issues broadly, targeting the opioid crisis predominantly through public health and law enforcement strategies. The Cures Act, enacted that same year, largely focused on medical innovation but also authorized additional funding to combat opioid addiction and included provisions addressing various mental health and substance use activities.

CRS is publishing a series of reports on the SUPPORT Act, which consists of eight titles. This report summarizes the provisions in Title III—the FDA (Food and Drug Administration) and Controlled Substance Provisions, as well as Section 4004 “Modernizing the Reporting Requirements of Biological and Biosimilar Products” in Title IV—Offsets.

Subtitle A of Title III addresses FDA medical product regulation and includes provisions that, among other things,

facilitate the development of new medical products for treatment of pain,

provide for special packaging and disposal mechanisms for opioids, and

amend postmarket study and labeling requirements.

Subtitle B of Title III addresses Drug Enforcement Administration (DEA) regulation of controlled substances and includes provisions that, among other things,

provide additional flexibility with respect to medication-assisted treatment (MAT) for opioid use disorders,

modify controlled substances disposal requirements at qualified hospice programs, and

authorize grants to states to increase participation of eligible collectors in drug-disposal programs.

Section 4004 of Title IV amends reporting requirements for certain agreements between brand drug, generic drug, and biosimilar product manufacturers.