LSHC Horizons Brochure 2024 - Flipbook - Page 88
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | United States
A new age of psychedelics
Industry innovators are looking forward to
an expanding class of FDA-approved drugs:
psychedelics. Over the past few decades,
researchers have demonstrated the great
promise of these new therapies, particularly for
psychiatric conditions.
FDA is gearing up, too. In 2023, the agency
issued a landmark draft guidance providing
recommendations for the development of and
clinical trials for psychedelic drugs. FDA Draft
Guidance for Industry, Psychedelic Drugs:
Considerations for Clinical Investigations
(June 2023). The guidance also highlights key
challenges in designing effective clinical trials,
developing effective chemistry, manufacturing,
and controls (CMC) information for botanicals,
assessing abuse potential, and monitoring
safety, among other topics.
The pioneers aiming to develop, gain approval
and commercialize these treatments will also
face practical challenges in marketing these
formerly taboo drugs.
• REMS: FDA may impose restrictions on
the approval through a Risk Evaluation and
Mitigation Strategy (REMS). A REMS could
come in many forms, such as a provider
and/or pharmacy certification program,
restrictions on the distribution, patient
monitoring and additional safety measures
and reporting obligations. Although REMS
are intended to ensure that the benefits of
the drug outweigh its risks, these restrictions
can hinder patient access, perpetuate stigma
about the product, and have outsized impacts
on commercial prospects.
Lynn Mehler
Partner
Washington, D.C.
• DEA scheduling: Many, if not all,
psychedelic substances under development
for or consideration for pharmaceutical
use are currently controlled in Schedule I
of the federal Controlled Substances Act
(CSA) and similarly controlled at the state
level. While there is a path through federal
and state law for research and approval of
Schedule I products, manufacturers will not
be able to distribute and sell their products
immediately upon FDA approval and
must wait for the U.S. Drug Enforcement
Administration (DEA) to reschedule the
product. Prior to commercial launch, DEA
must issue an interim final rule rescheduling
the substance or product under the CSA.
Similar rescheduling at the state level is also
necessary. At the federal level, DEA’s interim
final rule is expected within 90 days of the
later of (1) the date DEA receives the U.S.
Department of Health and Human Services
scheduling recommendation or (2) the date
DEA receives notice of drug approval.
• DEA registration and state licensing:
Manufacturers and their distributors will
also need to assess the need for and obtain
any necessary federal and state controlled
substances registrations (in addition to other
required state licenses). These assessments
are fact-specific and often hinge on the
structure of the supply chain.
Eva Marie Schifini
Associate
Los Angeles
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