This morning, the U.S. House Committee on Energy and Commerce will hold a
markup on bipartisan legislation that would increase transparency in generic
drug applications (H.R.1843). 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.





 

U.S. HOUSE COMMITTEE SHOULD ADVANCE Q1/Q2 REFORMS TO PROMOTE GREATER
COMPETITION AND HELP LOWER PRESCRIPTION DRUG PRICES

Lawmakers Should Advance Bipartisan, Market-Based Solution to Crack Down on
Anti-Competitive Tactic Used by Big Pharma to Extend Exclusivity, Keep Drug
Prices High



This morning, the U.S. House Committee on Energy and Commerce will hold a
markup
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on bipartisan legislation that would increase transparency in generic drug
applications (H.R.1843
<[link removed]>).
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.



The legislation, sponsored by U.S. Representatives Neal Dunn and Kevin Mullin,
was re-introduced this Congress to help foster greater competition from more
affordable generic alternatives to high-priced brand name drugs. Companion
legislation (S.1302
<[link removed]>) in the
U.S. Senate, sponsored by Senators Maggie Hassan, John Hickenlooper, Mike Lee,
Rand Paul and James Lankford, is currently before the Committee on Health,
Education, Labor and Pensions (HELP).



According to the nonpartisan Congressional Budget Office (CBO), this solution
would deliver more than $1 billion in savings.



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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.



Learn more about market-based solutions to hold Big Pharma accountable and
lower drug pricesHERE
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.



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