Innovations-Magazine-May-2022 - 4

User Fees Present Rare Must-Pass Bill This Congress
Lauren K. Bloch, MPA
Faegre Drinker Biddle & Reath LLP
Like clockwork, every five years since 1992,
Congress has enacted laws to enable Food
and Drug Administration (FDA) to receive
fees from industry to help offset a portion
of the agency's product review work. Known
as the user fee agreement, or " UFA, " the
current iteration of these laws is set to expire
and must be updated by September 2022.
Spurred by anger and frustration from
HIV/AIDS activists that FDA was too
slow to review and approve drugs to treat
that pandemic, Congress enacted the first
UFA, known as the Prescription Drug
User Fee Act (PDUFA), which was focused
on prescription drugs. The intent of user
fees has been fairly simple: bolster FDA
review capabilities by enabling industry to
offset some of the costs via user fees. Over
the years, the UFA negotiated by FDA
and industry segments would expand to
include agreements for medical devices,
generics, biosimilars, animal drugs, and
more. FDA collects these fees for almost
all product applications, with a small
number of exceptions, such as for products
to treat orphan or rare diseases.
The process of developing UFAs every five
Nicholas P. Manetto
Faegre Drinker Biddle & Reath LLP
years is multifaceted. It involves a period of
intense negotiations between FDA and the
respective industries to negotiate specific
performance metrics and goals to coincide
with the payments, followed by Congress
enacting legislation to enable FDA to
collect said fees.
FDA and industry conversations - as
well as several rounds of meetings with
patient advocacy groups and other
stakeholders - have occurred over the past
year on many of the UFA. These meetings
provide an opportunity for FDA to share
its plans for the next five years and to get
feedback from stakeholders. In late August
2021, FDA released the commitment
letter or performance goals for the PDUFA
covering fiscal years (FYs) 2023 to 2027.
As we inch closer to the end of FY 2022,
Congress will have to enact legislation to
authorize FDA to accept user fees for FY
2023 through FY 2027.
2 | MAY 2022
In addition to permitting FDA to continue
collecting industry user fees, the user fee
bills have also been mediums through which
Congress has enacted other FDA-related
statutes over the past three decades.
For example, in 2012, the FDA Safety and
Innovation Act (which included PDUFA
V) was notable for including provisions
that ushered in the field of patient-focused
drug development (PFDD), amended
the accelerated approval and fast track
pathways, and created the breakthrough
therapy designation. These provided new
opportunities for drug developers to seek
expedited approval for their products. In
2007, the FDA Amendments Act (PDUFA
IV) included provisions on pediatric
medical device development as well as new
requirements for post-market studies and
adverse event reporting. These safety and
reporting requirements were driven by the
recall and related issues around the drug
earlier in the decade and a desire by
Congress for more proactive monitoring of
high-risk products.
Congress has also addressed FDA's
priorities outside of the user fee laws. Some
recent examples of this approach include
the 2013 enactment of the Drug Quality
and Security Act, driven, in part, by a
response to a fungal meningitis outbreak
linked to a compounding pharmacy, and
the 21st
Century Cures Act, which was
enacted in late 2016 and contained multiple
FDA-focused provisions. But the lack of
a legislative imperative outside of user fee
authorization years means many stakeholders
prioritize including a provision within the
user fee package.
What Will Come in PDUFA VII?
In 2022, Congress - particularly the House
Committee on Energy and Commerce
and the Senate Committee on Health,
Education, Labor and Pensions (HELP) -
will move forward with hearings to lay the
foundation for the legislation.
In early February, the House Energy and
Commerce Health Subcommittee kicked off
the process with a hearing on the user fees.


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

Innovations-Magazine-May-2022 - 1
Innovations-Magazine-May-2022 - 2
Innovations-Magazine-May-2022 - 3
Innovations-Magazine-May-2022 - 4
Innovations-Magazine-May-2022 - 5
Innovations-Magazine-May-2022 - 6
Innovations-Magazine-May-2022 - 7
Innovations-Magazine-May-2022 - 8
Innovations-Magazine-May-2022 - 9
Innovations-Magazine-May-2022 - 10
Innovations-Magazine-May-2022 - 11
Innovations-Magazine-May-2022 - 12
Innovations-Magazine-May-2022 - 13
Innovations-Magazine-May-2022 - 14
Innovations-Magazine-May-2022 - 15
Innovations-Magazine-May-2022 - 16
Innovations-Magazine-May-2022 - 17