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 the Give Kids a Chance Act of 2025 (H.R. 1262), which includes bipartisan provisions from the Increasing Access to Generic Drug Applications Act (H.R. 1843) 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 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 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.”