Life Sciences Horizons Brochure 2025 - Flipbook - Page 41
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2025 Horizons Life Sciences and Health Care
Trends, innovations, and growth potential between the U.S. and Mexico
The recent ruling by the U.S. Court of Appeals for the
Ninth Circuit in USA v. California Stem Cell Treatment
Center, Inc. has made a significant impact on the stem
cell treatment industry. This decision confirms that
certain stem cell products are “drugs” under the
Federal Food, Drug, and Cosmetic Act (FDCA) - a
determination that will have far-reaching implications
for companies developing innovative stem cell
therapies. Consequently, these companies must
navigate the complexities of the FDA’s premarket
approval process.
One potential option is for companies to explore regulatory
frameworks outside the U.S. that are more accommodating,
particularly in countries where stem cell products are not
classified as “drugs.” Mexico is an attractive choice among these
options due to its proximity to the U.S. and its more flexible
regulatory environment.
Mexico’s regulatory agency, COFEPRIS (Federal Commission
for the Protection Against Sanitary Risks), has established
a framework that many regard as more flexible for stem cell
therapies compared to FDA’s oversight. Unlike in the U.S.,
where FDA approval requires extensive premarket clinical
trials, COFEPRIS takes a more flexible approach for certain
stem cell-based products and therapies. This flexibility enables
companies to bring their treatments to market faster, meeting
patient needs without the prolonged delays, and high costs
associated with FDA approval.
By leveraging Mexico’s more lenient regulatory landscape,
companies can significantly reduce development timelines and
costs, giving them a competitive advantage and the ability to
respond to market demands more efficiently. However, to succeed
in this new environment, companies must collaborate closely
with local partners well-versed in Mexico’s legal and regulatory
framework. This collaboration will be critical for navigating
challenges and ensuring compliance with local laws, regulations,
and ethical standards.
In sum, the Ninth Circuit’s ruling highlights the increasing
regulatory challenges for stem cell companies in the U.S.,
prompting the need for creative solutions. Mexico’s more flexible
regulatory environment offers a promising opportunity for
companies looking to accelerate product development and
reduce costs. However, success in this space requires more than
just crossing borders; it demands strategic collaboration with
local experts and a clear understanding of Mexico’s regulatory
landscape. With the right approach, companies can navigate the
shifting landscape and continue driving innovation in stem cell
therapies to benefit patients worldwide.
Carlos Ramos Miranda
Partner
Mexico City
Cecilia Stahlhut Espinosa
Counsel
Mexico City
Daniel Garcia
Senior Associate
Houston
