LS&HC Horizons 2022 - Flipbook - Page 71
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
71
United States
Combination products and Part 4 compliance
We expect pharmaceutical and medical device companies to continue
and find new ways for developing products that combine their current
products with another drug, medical device, or biological product,
to identify eligible patients sooner and improve health outcomes.
Continued advancements in the life science and medical device
industries, specifically combination products, have propelled FDA to
establish a comprehensive regulatory framework for the design and
regulation of these products to ensure their safety and quality. Firms
who have historically occupied one area (drugs, biologics or medical
device) and have limited experience in the other areas should consider
necessary programmatic changes to their quality system at early stages
of product development to ensure compliance with the requirements
set forth under 21 CFR Part 4 (Part 4) with regard to good combination
manufacturing practice and postmarket safety reporting requirements.
Early planning and careful consideration of the unique regulatory and
compliance challenges that combination products raise are essential. There
are key differences to GMP approaches for specific types of combination
products (e.g., prefilled syringe, drug-coated gauze/sponge), and different
requirements for postmarket safety reporting for combination products
and constituent parts. Earlier this year, FDA published a final guidance
on principles of premarket pathways for combination products, and we
anticipate additional guidance related to GMP compliance, performance
requirements, and postmarket changes, among others, which may require
additional updates to quality systems. FDA set compliance dates for
certain postmarket safety reporting requirements though enforcement was
impacted by the ongoing Covid-19 pandemic. That said, the requirements
have been in place and compliance expected for long enough that the
Agency is likely to expect that manufacturers have had sufficient time and
opportunity to achieve compliance. As public health concerns and travel
restrictions ease, we expect to see an increasing number of site inspections
and assessments to evaluate combination product manufacturers’
compliance with Part 4 requirements.
We know Part 4 compliance well, and we leverage our keen
understanding of drug and device GMP requirements, trends and
proposed regulatory changes, to provide practical approaches to achieve
and sustain compliance. We will work closely with our clients to navigate
the evolving regulatory landscape for combination products.
Michael Heyl
Partner, Washington, D.C.
Jodi Scott
Partner, Denver
Lowell Zeta
Partner, Washington, D.C.
