HSCA’s President
and CEO Todd Ebert, R.Ph., released the following statement today in response
to the U.S. Food and Drug Administration’s (FDA) decision to begin prioritizing abbreviated new drug applications (ANDAs)
for generic drugs with only one manufacturer, sometimes known as “sole source”
products:
“We
applaud the FDA for taking this important first step to expand patient access
to critical generic medications. Expediting the review and approval process for
generic drugs with only one manufacturer will help increase competition in the
market, mitigate generic drug price spikes, and alleviate future drug shortages.
“The
Healthcare Supply Chain Association and our member GPOs have a unique line of
sight into the causes of generic price spikes, and we are committed to reducing
costs and increasing competition and innovation in the market. We have worked
with Congress, FDA, and industry stakeholders to adopt practical solutions,
including review prioritization, to help address generic price spikes.
“While
the FDA decision to authorize expedited review of sole-source product
applications will help foster competition in the generic drug market, there is
more to be done to ensure generic medications are accessible and affordable to
healthcare providers and patients who rely on them. We encourage Congress and
FDA to prioritize review of generic drugs with two or fewer manufacturers, or
where a price spike has already occurred, particularly in the generic
injectable market. We look forward to continuing to work with bipartisan leaders
from the Senate HELP and Special Aging Committees, as well as the FDA, on other
solutions to generic drug access.”
To read Todd
Ebert’s full statement on the FDA's decision to expedite ANDAs for sole source
products, click
here.