WASHINGTON, DC — A DEA administrative law judge has stayed the marijuana rescheduling proceeding for two weeks and ordered supplemental briefing following a Government Accountability Office report on how federal agencies schedule controlled substances.
The entire rescheduling rests on a Justice Department opinion holding that HHS’s novel two-part test alone established marijuana has a currently accepted medical use. That test was created only after marijuana failed DEA’s long-standing five-part test, a point a government scientist conceded under questioning from SAM’s counsel during the rescheduling hearing.
Now FDA officials have told GAO that the two-part test “has not replaced other methods for determining currently accepted medical use; rather the two-part test is an additional framework,” and that “FDA approval of a new drug application remains the most straightforward way to establish that a drug has a currently accepted medical use in treatment in the U.S.”
“The two-part test is a facade. It was invented because marijuana failed the real test, the government’s own scientist admitted that on the stand, and now FDA has told federal auditors that was never the standard to begin with,” said Kevin A. Sabet, Ph.D., president of Smart Approaches to Marijuana and a former advisor to three U.S. presidents. “An entire rescheduling was built on a shortcut its own authors call optional. That is not science. It is improvisation with a lab coat on, and the stakes are every kid in America.”
GAO’s other findings:
- “DEA does not have any policies or procedures regarding how its staff are to conduct evaluations or schedule substances.”
- FDA has no definition for a substance’s “potential for abuse,” the central statutory question in every scheduling decision. Officials conceded they fill the gap with “professional judgment.”
- The memorandum governing how FDA consults the National Institute on Drug Abuse on scheduling is more than 40 years old and “does not reflect the current entities involved or procedures.”
GAO warned these gaps “may pose a risk to the consistency of DEA’s and FDA’s future operations.” Every agency concurred with its recommendations.
