Bipartisan, Market-Based Solution Would Increase Transparency, Help Stop Big
Pharma from Delaying Generic Competition





 



CSRXP APPLAUDS U.S. HOUSE PASSAGE OF Q1/Q2 REFORMS TO FOSTER GREATER
COMPETITION IN THE PRESCRIPTION DRUG MARKETPLACE

Bipartisan, Market-Based Solution Would Increase Transparency, Help Stop Big
Pharma from Delaying Generic Competition



Washington, D.C. – The Campaign for Sustainable Rx Pricing (CSRxP) released
the following statement Monday after the U.S. House of Representatives passed
theGive Kids a Chance Act of 2025 (H.R. 1262
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includes bipartisan provisions from theIncreasing Access to Generic Drug
Applications Act (H.R. 1843
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) to improve transparency in generic drug applications.



“CSRxP applauds the House for advancing bipartisan, market-based reforms to
increase transparency in generic drug applications and help stop Big Pharma
from exploiting Q1/Q2 requirements to delay competition and keep drug prices
high,” said CSRxP executive director Lauren Aronson. “We urge the Senate to
swiftly pass this commonsense solution to help foster greater competition from
more affordable alternatives to high-priced brand name drugs.”



This bipartisan, market-based solution would reform the Q1/Q2 sameness
requirements from the U.S. Food and Drug Administration (FDA) that Big Pharma
abuses to extend exclusivity, promoting a more efficient and streamlined
generic drug approval process. These reforms were adopted as an amendment
during the House Energy and Commerce Committee markup in September, where they
advanced unanimously by a vote of 47-0.



More on Q1/Q2 Reforms



One way Big Pharma games the system to block competition from more affordable
alternatives to high-priced brand name drugs is by abusing a process known as
“Q1/Q2 sameness.” This refers to a requirement from the FDAthat
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“generic drug manufacturers mimic the brand-name drug formulation for certain
formulations” so that these drugs are “Qualitatively the same, or Q1,” meaning
they contain the “same inactive ingredients,” and that they are also
“Quantitively the same, or Q2,” in that they have “essentially the same
concentration” of these ingredients.



The problem arises in the fact that brand name drug makers can assert “trade
secret protection” around many of the products generic drug makers are
attempting to copy, meaning generic drug manufacturers have to “essentially
play a protracted guessing game with FDA,” as Association for Accessible
Medicines (AAM) CEO John Murphy III put it in a June 2024column
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. Murphy added, this leads to “a lot of spilled ink, wasted resources and
unnecessary red tape,” and has “delayed generic competition, and in particular
competition for critical complex products—a growing category of medicines that
have complex active ingredients, formulations, or routes of administration—that
are frequently expensive and desperately require generic competition.”



A prominent example is brand name drug maker Allergan’s dry eye drug Restasis.
According to Murphy, “[i]t took FDA nine years to approve a generic version of
Restasis because of asserted formulation trade secret claims by the brand-name
manufacturer, Allergan. During that time, U.S. patients and payers were
shelling out a lot for the extraordinarily expensive brand-name drug even
though the relevant patents on Restasis had long been invalidated or expired.”



Read more on H.R.1843 HERE
<[link removed]>.



Read more on Q1/Q2 reforms HERE
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.



Read more on bipartisan, market-based solutions to hold Big Pharma accountable
HERE <[link removed]>.



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