President Trump Signs SUPPORT for Patients and Communities Act | Practical Law

President Trump Signs SUPPORT for Patients and Communities Act | Practical Law

President Trump signed into law the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT for Patients and Communities Act), bipartisan legislation that aims to combat the opioid addiction crisis.

President Trump Signs SUPPORT for Patients and Communities Act

Practical Law Legal Update w-017-2980 (Approx. 3 pages)

President Trump Signs SUPPORT for Patients and Communities Act

by Practical Law Life Sciences
Published on 31 Oct 2018 • USA (National/Federal)
President Trump signed into law the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT for Patients and Communities Act), bipartisan legislation that aims to combat the opioid addiction crisis.
On October 24, 2018, President Trump signed into law H.R. 6, known as the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT for Patients and Communities Act; Pub. L. No. 115-271). The legislation amends the Food, Drug, and Cosmetic Act (FDCA), Social Security Act, Controlled Substances Act, and other laws to help opioid use disorder prevention, recovery, and treatment. The legislation grants the FDA additional authority to:
  • Improve screening in international mail facilities to help stop illegal, illicit, unapproved, counterfeit, and potentially dangerous drugs from entering the US (Pub. L. No. 115-271 § 3014).
  • Debar individuals or companies convicted of a felony involving importing illegal drugs or engaged in a pattern of importing certain adulterated or misbranded drugs for commercial sale (Pub. L. No. 115-271 § 3022). A debarred individual or company cannot provide services in any capacity to a sponsor of an approved or pending drug product application (21 U.S.C. § 335a(a)-(g)).
  • Order mandatory recall of a controlled substance if there is a reasonable probability that it would cause serious adverse health consequences or death (Pub. L. No. 115-271 § 3012).
  • Require certain packaging for opioids and other drugs that pose a risk of abuse or overdose, such as unit-dose blister packs or mail-back pouches for safe disposal (Pub. L. No. 115-271 § 3032).
The SUPPORT for Patients and Communities Act also clarifies the FDA's authority to:
Sources: SUPPORT for Patients and Communities Act, Pub. L. No. 115-271 (2018) and FDA: Statement from FDA Commissioner Scott Gottlieb, M.D., on How New Regulatory Authorities Will Assist the Agency in More Forcefully Addressing Opioid Crisis; Included as Part of the Newly Enacted Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, October 24, 2018.