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3 Advantages of Post-Approval
Research and Development
March 1, 2022 Pharmaceutical Development
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Table of Contents
R&D Continues Long After a Treatment Is Authorized and Reaches Patients
Life-Changing Bene ts for Patients
Solving Unmet Patient Needs

Despite signi cant progress and understanding acquired through post-approval R&D, some members of
Congress continue to fail to understand that innovation does not cease after the U.S. Food and Drug
Administration (FDA) cle   arance. Scientists and clinicians continue to create knowledge on new treatments or
vaccinations after they have been approved, as we witness with COVID-19 vaccines today. This is done for
both authorized indications (and possibly developing the drug for additional, supplementary indications)
addressing critical unmet medical needs.

The most recent medication pricing plan offers the government an additional ability to set Medicare costs once
a product has been on the market for 7 small molecule drugs or 11 biologics years. It’s referred to as
“negotiating,” but it’s not. The current proposal not only incorporates some of the same price-setting practices
as H.R. 3, which threaten access to medications, but it also eliminates important incentives needed to stimulate
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further R&D investment, after drugs are authorized.
settings ACCEPT
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In this blog, we’re going to clear the air on why post-approval gains are so crucial and should be encouraged,

not discouraged.

R&D Continues Long After a Treatment Is Authorized and

Reaches Patients
Medical breakthroughs for patients often do not stop with the rst FDA clearance. Rather, researchers use
what they’ve learned in order to in uence future studies on FDA-approved medications. This research is time
and resource exhausting (and scienti cally hard), often necessitating further clinical studies and considerable
data collecting before the FDA issues any new clearances (or product label changes).

Many of these advancements which have occurred post initial FDA approval have led to better survival rates,
improved patient outcomes, and improved quality of life for patients with cancer, autoimmune illnesses and
rare diseases. Biopharmaceutical rms are dedicated to nding treatments and cures to help people live longer,
improved lives, whether they are developing new medicines or nding novel methods to produce, deliver and
expand existing authorized medications.

Life-Changing Bene ts for Patients

Once treatment is licensed, researchers go above and beyond to identify any extra advantages for patients.
Additional studies may show that the drug can be used to treat a wide range of ailments including various types
of cancer and other disorders. Additional study in certain situations reveals that treatment can also be used for
various stages of the same illness, such as the early stages of cancer. In some circumstances, extra research
leads to greater safety or ef cacy of a drug (and novel dosage forms or administration methods) which might
improve patient adherence and convenience, resulting in better patient outcomes. These are substantial
advancements which would not have been possible without post-approval research.

Solving Unmet Patient Needs

Congress has enacted policies which help companies do more research after a drug is approved. These policies
help companies conduct the big, dif cult research needed to nd new treatments for more unmet medical
needs. Congress passed laws such as the Best Pharmaceuticals for Children Act (BPCA) and the Orphan Drug
Act (ODA) to stimulate investment in areas with a great deal of scienti c uncertainty and unmet patient needs.
These policies have led to important bene ts for patients.

The BPCA encourages companies to do research for children and adults. Companies get an extra 6 months of
exclusivity for the medicine if they research children and the FDA approves it. Incentives in the BPCA
encourage sponsors to invest in pediatric research, even though there are many challenges such as smaller
disease populations; restrictions on blood volume and tissue sampling; the impact on the school and family life;
and the need for informed consent.

The ODA was passed in 1983

and since then, the FDA has
approved more than 600
medicines for rare diseases.
Many of these new
applications came from
medicines already approved
for use in other groups (or
with other illnesses). There
were fewer than 10 medicines
for rare diseases in the
decade before ODA. Even
though there have been many
new treatment options
recently, rare and pediatric diseases still have a lot of unmet needs. More than 90% of rare diseases (including
those that affect children) don’t have treatment.

Given the signi cance of post-approval improvements to so many patients, it is very unfortunate that certain
members of Congress are pursuing a price-setting strategy threatening them, eventually leading to fewer
breakthroughs on which so many patients rely. Now is not the time for Congress to sti e scienti c progress.

To obtain more information about the advantages of post-approval R&D, visit Rondaxe online or call us in New
York at (315) 469-2800 today.
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