Life Sciences Horizons Brochure 2025 - Flipbook - Page 116
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2025 Horizons Life Sciences and Health Care
Increasing state board enforcement against device firms, and the
role of the DSCSA (continued)
The increased scrutiny from state Boards of Pharmacy has led to
a number of unique challenges for prescription medical device
companies, including:
Complex compliance burdens: Unlike the pharmaceutical
industry, where state-based requirements are generally in line
with the DSCSA’s unified framework such that licensing
expectations are relatively predictable, medical device
manufacturers and distributors must discern and comply with
a diverse set of state-level regulations. For example, companies
operating in multiple states may face varying licensing fees,
inspection requirements, and reporting obligations; and while
some states require applicants to provide a large amount of
documentation to accompany an application, other states
require none.
Increased legal risks: Failure to comply with state regulations
can result in penalties, license revocation, or other legal action.
Some states have pursued aggressive enforcement measures,
leading to reputational damage and costly fines for noncompliant companies, which have in some cases reached
six-figure penalties.
Market access and distribution challenges: Companies
that fail to anticipate and satisfy state-specific licensing
requirements risk being unable to distribute their products in
certain states, disrupting supply chains and limiting patient
access to essential prescription medical devices. Moreover,
a firm that is disciplined in a single state is likely to receive
discipline and potentially suffer business disruptions in other
states due to Board of Pharmacy reporting requirements.
Uncertainty in regulatory oversight: A lack of federal
guidance (comparable to the DSCSA for medical devices)
imposes unique burdens on manufacturers and distributors as
they attempt to discern the requirements that are applicable
to their business. Adding to this uncertainty, state Boards of
Pharmacy commonly establish enforcement policies and
regulatory interpretations that may differ from the text of
governing state laws. Medical device companies must therefore
constantly monitor regulatory developments at the state level
to ensure they remain in compliance.
Given the increasing enforcement activity by state Boards of
Pharmacy, industry stakeholders are yearning for a standardized
regulatory framework for prescription medical device
distribution. Some trade associations and lobbying groups have
pushed for federal legislation to establish a national system akin
to DSCSA for medical devices, thereby reducing the regulatory
burden caused by highly variable, and ever-changing state-based
regulatory regimes. However, it is likely that states will continue
along the current trend of incrementally applying pharmaceutical
requirements to medical device firms, coupled with heightened
enforcement efforts.
To succeed in this environment, medical device manufacturers
and distributors are proactively assessing state-based
requirements, implementing rigorous internal compliance
programs, and closely monitoring state-based regulatory changes
and enforcement trends to navigate the evolving landscape.
Jodi Scott
Partner
Denver
Wil Henderson
Counsel
Denver
Gregory Adam Kass
Associate
Denver
Lauren Massie
Associate
Denver
