Innovations-Magazine-May-2022 - 5

Hearing witnesses included leadership from
the FDA centers responsible for drugs and
biologics, as well as representatives from the
life sciences industry. FDA speakers noted
their plans to increase engagement with
patient communities under the next UFA
period. They highlighted the agency's plans
to continue exploring less conventional
ways of collecting evidence for regulatory
decision making, including the use of
biomarkers, intermediate endpoints, and
real-world evidence. They also plan to
issue further guidance on their accelerated
approval pathway, which has come under
fire recently following a controversial
approval of an Alzheimer's drug in 2021.
FDA leaders also emphasized their
intention to continue reviewing and
approving coronavirus disease 2019
(COVID-19) vaccines and treatments in
a timely manner, even if the governmentdeclared
public health emergency, a status
that gives FDA additional flexibility in its
processes, sunsets.
While the legislation is still in
development as of press time, we anticipate a
continued emphasis on provisions to advance
the involvement of patients in the therapy
development process, known as PFDD or
patient engagement. These provisions have
been very popular with patients and the
industry, particularly patients and caregivers
impacted by rare and life-threatening
diseases who have long advocated in support
of policies that give heed to their desires,
including a willingness to accept greater
potential risks when no other treatment
options exist.
Congress is also likely to include more
provisions related to FDA's use of real-world
evidence in its regulatory decision making.
Real-world evidence is information collected
about the use of medical products outside of
a clinical trial. For the past several years, both
Congress and FDA have placed an increasing
emphasis on this approach, and FDA
included goals on this topic in the PDUFA
commitment letter. Real-world evidence has
been in the spotlight recently, as it has played
a role in the COVID-19 vaccines receiving
Although not within the purview of FDA, the issue
of medication costs remains very much on the radar,
and it is possible that provisions on this topic could be
passed along with the UFA as a part of a larger
legislative package.
full FDA approval after initially being
authorized solely for emergency use.
On the flip side, some recent FDA
approvals have triggered concerns about
the FDA approval and evidentiary process,
particularly when the product's price tag is
significant and efficacy is questioned. This
may lead some lawmakers to oppose policies
they view as contributing to such approvals.
Although not within the purview of FDA,
the issue of medication costs remains very
much on the radar, and it is possible that
provisions on this topic could be passed
along with the UFA as a part of a larger
legislative package. Last year, Democrats
in Congress were seeking to advance the
Build Back Better Act legislation that would
have opened the door to direct Medicare
negotiations with drug manufacturers for
a subset of drugs covered by the Medicare
Part D prescription drug benefit.
Specifically, the provision would have
identified a subset of drugs that lack any
generic or biosimilar alternatives and
that are among the most expensive to
the Medicare program and made them
the subject of direct negotiations. The
biopharmaceutical sector has vigorously
opposed any such direct negotiations.
While Build Back Better remains stalled
as of press time, congressional Democrats
are debating potentially carving up the bill
into smaller pieces to advance components
of it and may look at the user fee package
as a potential vehicle for this or other drug
pricing provisions.
The Anticipated Path Forward
Much of the remainder of the year will
be influenced by positioning ahead of the
November midterm elections that will
determine which party controls the House
and the Senate come January 2023. Congress
typically does less legislating during election
years, so the user fee reauthorization bill
presents a rare " must-pass " bill that has in
the past enjoyed strong bipartisan support.
Over the spring and summer, we
anticipate the Energy and Commerce and
HELP Committees will further develop
and advance the legislation heading toward
summer floor activity with a goal of
enactment before the August congressional
recess. But with a very fluid landscape
dominated by political positioning, NABP
will want to pay closer attention to events
over the coming weeks.
This article was written by Lauren K. Bloch,
MPA, and Nicholas P. Manetto with Faegre
Drinker Biddle & Reath LLP. Please note, the
opinions and views expressed by Faegre Drinker
Biddle & Reath do not necessarily reflect the
official views, opinions, or policies of NABP or
any member board unless expressly stated.
MAY 2022 | 3


Table of Contents for the Digital Edition of Innovations-Magazine-May-2022

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