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), which contains bipartisan provisions from the Increasing Access to Generic Drug Applications Act (H.R. 1843), 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 FDA that “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 2024 column. 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.”