Washington (June 28, 2022) — Senator Edward J. Markey (D-Mass.) joined a bicameral group of lawmakers led by Senator Cory Booker (D-N.J.) on Monday asking the Biden Administration for information related to the scientific evaluations that the Department of Health and Human Services has conducted of fentanyl analogues. The letter expresses concerns over the Biden Administration’s proposal to make the current temporary classwide scheduling of fentanyl-related substances (FRS) permanent without proper scientific evaluation. As per recent testimony from the Food and Drug Administration (FDA), classwide scheduling may improperly classify FRS that may be harmless, or have a medical use, as Schedule I drugs, a designation reserved for the most dangerous substances that have no therapeutic use.

In a letter to the Attorney General Merrick Garland, Health and Human Services (HHS) Secretary Xavier Becerra, and Drug Enforcement Administration (DEA) Administrator Anne Millgram, the lawmakers wrote that “permanent classwide scheduling would absolve the government of its statutory responsibility to determine a substance’s potential for abuse or accepted medical use before placing it in a category of controlled substances.” The proposal would also “create a system in which some individuals may be prosecuted and sentenced to prison for substances that turn out to be harmless, which invariably will disproportionately impact people of color.”

As the letter notes, after members of the Senate Judiciary Committee wrote to then-HHS Secretary Alex Azar on this issue in 2019, the department found that “permanent scheduling of a class of substances, rather than specific substances, would not be feasible for the FDA to develop” and “could impede the development of treatments for opioid addiction and overdoses.” Schedule I drugs are the most difficult for researchers to study due to time-consuming protocols.

The lawmakers also highlight that in December 2021, the FDA testified before Congress that of the few FRS it has studied, “one does not make a person ‘high’ and could be a life-saving treatment.” Yet, the administration “has neither released any information about the substances it has studied nor explained which steps it is taking under current law to reclassify the substances it has concluded should not be in Schedule I.” The permanent classwide scheduling of FRS “without first conducting a scientific and medical evaluation—an evaluation that could lead to the discovery of a life-saving treatment—is contrary to evidence-based, public health solutions,” continue the lawmakers.

Furthermore, the lawmakers argue that temporary scheduling of FRS as Schedule I drugs “has not proven to be an effective solution to the country’s grim overdose crisis.” The letter cites data from the Centers for Disease Control and Prevention that show “overdose deaths involving synthetic opioids other than methadone increased 23 percent, from 58,000 to 71,000” between 2020 and 2021 alone.

The lawmakers concluded by requesting that the DEA release information related to FRS, including scientific and medical studies done on FRS by HHS or the FDA.

The letter was co-signed in the Senate by Senators Ed Markey (D-MA), Elizabeth Warren (D-MA), Mazie Hirono (D-HI), and Bernie Sanders (I-VT) and in the House by Representatives by Representatives Tony Cárdenas (D-CA-29th), Earl Blumenauer (D-OR-3rd), Yvette Clarke (D-NY-9th), Nydia Velazquez (D-NY-7th), Bonnie Watson Coleman (D-NJ-12th), Jan Schakowsky (D-IL-9th), Nanette Barragán (D-CA-44th), and Cori Bush (D-MO-1st).

Full text of the letter can be found here.