Pallone Introduces Legislation to Empower FDA to Combat Illicit Opioid Importation
Energy and Commerce Ranking Member Frank Pallone, Jr. (D-NJ) announced the introduction of H.R 5228, the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now (SCREEN) Act, which would increase funding to and expand the Food and Drug Administration’s (FDA) authority to prevent illegally manufactured opioids, including heroin and fentanyl, from arriving overseas through the mail.
Opioid overdose death rates are the leading cause of unintentional, non-traumatic death in the United States, claiming approximately 116 lives per day or over 42,000 deaths per year. While increased use of prescription opioids has contributed to the opioid epidemic, the use of internationally manufactured synthetic opioids have sharply increased over the last five years and were responsible for 20,000 overdoses in 2016.
One of the many ways synthetic opioids reach the U.S. is through International Mail Facilities (IMFs), which receive millions of parcels containing illegal or unapproved drugs annually. The SCREEN Act would strengthen FDA’s authority to detain, refuse, and destroy illegal substances identified in IMFs, improve enforcement mechanisms, and provide funding to better combat the influx of illegally manufactured opioids into the country.
“If we are serious about combatting the opioid epidemic, we need to provide FDA with the funding and tools needed to take on the illicit drug trade taking place through the international mail system,” Pallone said. “The SCREEN Act will provide FDA with the expanded authority and capacity needed to more effectively combat the influx of deadly synthetic opioids like fentanyl reaching our shores through the mail. I look forward to working with my colleagues to pass the SCREEN Act soon.”
The SCREEN Act takes a number of important steps to improve FDA’s ability to combat importation of illegal substances like fentanyl, including:
- Grants FDA authority to refuse importation and destroy drugs on the basis that they have been identified as “articles of concern.”
- Allows FDA to destroy more than $2,500 worth of drugs (the maximum under current law) if the Agency determines it would be in the interest of public health to do so.
- Authorizes FDA to place an Emergency Recall Order and to cease distribution on drugs that may pose an imminent threat of adverse health effects or death.
- Gives FDA authority to debar (i.e. stop from operating) individuals or companies who exhibit recidivist activity. This is designed to prevent companies that have already been caught importing illegal substances from simply resuming activity under a new company name.
- Authorizes $110 million to FDA for fiscal years 2019 through 2023 to support innovation in non-opioid and non-addictive pain treatment, programs to increase access to opioid use disorder treatment, and to reduce illicit importation of opioids, including increasing staff capacity at IMFs.
Section-by-section available HERE.
Bill text available HERE.