CSRXP STATEMENT ON U.S. SENATE AND U.S. HOUSE REINTRODUCTION OF Q1/Q2 REFORMS TO FOSTER GREATER COMPETITION, LOWER DRUG PRICES

Apr 15, 2025

Lawmakers Should Advance Bipartisan Solution to Crack Down on Anti-Competitive Big Pharma Tactic

Washington, D.C. – The Campaign for Sustainable Rx Pricing (CSRxP) released the following statement Tuesday following the reintroduction of two bills to provide for increased transparency in generic drug applications (S.1302 and H.R.1843). The CSRxP-supported bills would reform the Q1/Q2 sameness requirements from the U.S. Food and Drug Administration (FDA) that Big Pharma abuses to extend exclusivity, allowing a more efficient and streamlined generic drug approval process.

“CSRxP applauds Senators Hassan, Hickenlooper, Lee and Paul as well as Representatives Dunn and Mullin for reintroducing these bipartisan solutions to reform the FDA’s Q1/Q2 sameness requirements and help foster greater competition from more affordable generic alternatives to high-priced brand name drugs,” said CSRxP executive director Lauren Aronson. “These market-based solutions will help prevent Big Pharma from gaming the system to block competition and keep drug prices high. We encourage members of the Senate Health, Education, Labor and Pensions (HELP) Committee, the House Energy and Commerce Committee, and the full Congress, to swiftly advance these bills to foster greater competition in the marketplace to lower prices for consumers.”

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 concerns a process known as “Q1/Q2 sameness,” which 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 wrote in a June 2024 column, 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.”

One example Murphy cites 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.”

According to AAM, Q1/Q2 reforms would “save the U.S. healthcare system nearly $900 million over 10 years and bring lower-cost medicines to patients sooner.”

Read more on S.1302 HERE and H.R.1843 HERE.