LS&HC Horizons 2023 - Flipbook - Page 70
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | United States
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Removing barriers to research with Schedule I controlled substances
Over the past decade, innovators in the
pharmaceutical industry have embraced
the therapeutic value and potential of drugs
typically associated with recreational use
– such as cannabis, marijuana, ketamine,
psychedelics, and other transformative
medicines. Regulators are finally catching up.
Late last year, the Biden Administration
passed the Medical Marijuana and Cannabidiol
Research Expansion Act to promote research
into marijuana, including its derivative
products. The law:
• simplifies and streamlines procedures
to permit clinical research of marijuana
– including by requiring the U.S. Drug
Enforcement Agency (DEA) to accept an
application for registration if the research
protocol has been approved by FDA through
the investigational new drug application
(IND) process or a federal agency that funds
scientific research, or if the applicant has
otherwise complied with DEA’s protocols
for researching Schedule I substances;
• removes the federal prohibition on doctors
discussing the benefits and harms of medical
marijuana with their patients; and
• directs federal agencies to research
and report on the therapeutic potential
of marijuana.
Other lawmakers are calling for similar
interventions to promote the development
of other Schedule I drugs, such as MDMA,
psylocibin, and LSD. For example, Senators
Cory Booker (D-NJ) and Rand Paul (R-KY)
are promoting the Breakthrough Therapies Act,
a bill designed to reduce barriers to researching
other Schedule I substances and improve
pre-approval access to these therapies through
FDA’s expanded access program.
In the coming years, we expect to see other
Schedule I substances gain approval for novel
uses and additional calls for lawmakers to
alleviate unnecessary burdens on innovator
companies developing and commercializing
these transformative medicines.
• encourages the cultivation of researchgrade marijuana – including by directing
DEA to increase the number of authorized
manufacturers;
Eva Marie Schifini
Associate, Los Angeles
Band One for Life
Sciences: Regulatory/
Compliance by
Chambers USA, 2022