Congress Passes Reforms to Increase Transparency, Prevent Big Pharma from
Delaying Generic Competition by Abusing Q1/Q2 Sameness Requirements





 



CSRXP APPLAUDS Q1/Q2 REFORMS ADVANCING TO PRESIDENT’S DESK, BIPARTISAN,
MARKET-BASED SOLUTION WILL HELP INCREASE COMPETITION IN THE PRESCRIPTION DRUG
MARKET

Congress Passes Reforms to Increase Transparency, Prevent Big Pharma from
Delaying Generic Competition by Abusing Q1/Q2 Sameness Requirements



Washington, D.C. – The Campaign for Sustainable Rx Pricing (CSRxP) released
the following statement applauding final passage in Congress of bipartisan
reforms to Q1/Q2 sameness requirements on Tuesday as part of a broader
government funding package.



“CSRxP applauds Congress for advancing bipartisan reforms to prevent Big
Pharma from gaming Q1/Q2 requirements to delay competition and keep
prescription drug prices high,” said CSRxP executive director Lauren Aronson.
“CSRxP has been a longstanding supporter of this market-based solution that
will bring greater transparency to the generic drug approval process and
promote stronger competition from more affordable alternatives to high-priced
brand-name medications. We look forward to it being signed into law by the
president.”



The U.S. House- and U.S. Senate-approved funding package includes the Give
Kids a Chance Act of 2025 (H.R. 1262
<[link removed]>), which
contains bipartisan provisions from theIncreasing Access to Generic Drug
Applications Act (H.R. 1843
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), that 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 originally adopted as an amendment during the House Energy
and Commerce Committee markup in September 2025, 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 the 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
<[link removed]>
.



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



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