Life Sciences Horizons Brochure 2025 - Flipbook - Page 60
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2025 Horizons Life Sciences and Health Care
Chevron doctrine’s demise brings promises & perils for life sciences firms
In June 2024, the U.S. Supreme Court issued Loper
Bright Enterprises v. Raimondo, its highly anticipated
decision overturning the 40-year old doctrine
established in Chevron v. Natural Resources Defense
Council, which had provided judicial deference to
administrative agencies’ interpretations of ambiguous
statutes under certain circumstances. The decision to
eliminate Chevron deference is placing increased
pressure on administrative agencies – including FDA
and CMS – when interpreting and applying the law in
instances where Congress was either unclear or left
gaps, as such decisions may be open to challenge by
regulated industries and increased scrutiny by the
federal courts.
Loper Bright replaces the former agency-friendly Chevron
standard with a framework under which a reviewing court must
determine the “best” interpretation of a statute, without giving
any deference to the agency on ambiguous statutory language.
The decision could open the door for challenges to long-held
agency positions, allowing for increased scrutiny of efforts by an
empowered Executive branch to interpret its statutory mandates.
Agencies, including FDA, are still entitled to some amount of
discretion on questions of fact, science, and policy to varying
degrees. They also retain the power to persuade the courts of the
“best” statutory interpretation when they are able to do so
convincingly. In many ways, fights that used to focus on legal
interpretations of statutory language may now morph into
disputes about the facts and science to which those legal
interpretations are applied. We have already seen, and expect
to continue to see, FDA providing more scientific and factual
justification or explanation for its decisions going forward. This
may also result in FDA deprioritizing rulemaking efforts, given
the increased burden to develop, implement and defend such
regulations, without the promise of Chevron deference as the
reward for its efforts. This is likely to be particularly true under
an administration that is prioritizing the removal of existing
regulations before any new regulation can be issued. We also
should expect explanation in writing on the agency’s current
thinking through guidance if such positions could give a court
reason to question the agency’s thinking.
The upshot? Life science companies now have a new tool in
their arsenal for challenging agency decisions, especially those for
which Congress has not delegated express or implied authority to
HHS or FDA. While we await future court decisions to clarify the
bounds of Loper Bright, we highlight the following key areas
below that we are closely monitoring in 2025 and beyond:
FDA’s determinations on marketing exclusivity.
FDA’s efforts to assert sole regulatory authority over laboratory
developed tests (LDTs), supplanting CMS authority over the
laboratory developers and HHS oversight of both FDA and
CMS.
Product designations prior to marketing and reimbursement/
coverage decisions impacted by those designations.
Now more than ever, it will be important for affected parties to
follow developments and engage with the relevant agencies, such
as through commenting on proposed regulations or guidances,
and to focus their correspondence with regulators on helping the
agencies determine and substantiate the best interpretation of
relevant statutory text.
Susan Cook
Partner
Washington, D.C.
Lynn Mehler
Partner
Washington, D.C.
Randy Prebula
Partner
Washington, D.C.
Deborah Cho
Counsel
Washington, D.C.
Danielle Desaulniers
Stempel
Senior Associate
Washington, D.C.
