LS&HC Horizons 2022 - Flipbook - Page 67
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
67
United States
FDA formal dispute resolution and administrative
hearing procedures
FDA has reported a significant uptick in the use of dispute resolution
and other appeals procedures by sponsors in recent years. In the past
two years, sponsors have even pursued a less commonly used formal
administrative hearing process before FDA, in order to challenge
agency proposals to deny or withdraw approval of their new drug
applications. These trends highlight the importance of leveraging
the appropriate mechanisms to resolve disputes with FDA, ranging
from informal “pushback” in meetings or during the review process to
formal hearings and even litigation.
There are a number of considerations in determining the appropriate
dispute approach, including:
• S
ubject Matter: Is the dispute scientific, procedural, or legal/
regulatory in nature?
• P
urpose: What is the desired outcome? Additional agency
interaction or a new audience?
• P
rocess: Is a public forum desired? What information can
be included in the dispute record?
• T
iming: Where is the product in the review process?
Has the sponsor exhausted all administrative remedies?
For example, a formal administrative hearing is a public process,
with sponsor and FDA submissions and comments in a public docket,
which may be necessary in order to take the dispute to court. Nonpublic interactions to resolve scientific/medical disputes between
the sponsor and a review division include informal correspondence
before approval as well as Formal Dispute Resolution after a Complete
Response Letter.
Regardless of the mechanism selected, the likelihood of success
can depend on several factors, such as identifying red flags early,
creating a thorough record, knowing the procedure and audience,
and understanding different successful outcomes. When issues arise,
sponsors need to methodically evaluate all options in light of their
specific goals and sensitivities.
Lynn Mehler
Partner, Washington, D.C.
George O’Brien
Partner, Washington, D.C.
Komal Nigam
Senior Associate, Washington, D.C.
Sally Gu
Associate, Washington, D.C.
