On Thursday, the U.S. House passed bipartisan reforms to Q1/Q2 sameness
requirements as part of the so-called “minibus” funding package.





 

January 23, 2026



TOPLINE



On Thursday, the U.S. House passed bipartisan reforms to Q1/Q2 sameness
requirements as part of the so-called “minibus” funding package. These
solutions would reform the Q1/Q2 sameness requirements from the U.S. Food and
Drug Administration (FDA) that Big Pharma abuses to extend exclusivity on brand
name products and maintain monopoly pricing.



“CSRxP applauds the House for passing bipartisan reforms to stop Big Pharma
from exploiting Q1/Q2 requirements to delay competition and keep prescription
drug prices high,” said CSRxP executive director Lauren Aronson in astatement
<[link removed]>
. “We encourage the full Congress to swiftly advance this market-based solution
to increase transparency in generic drug applications and help foster greater
competition from more affordable alternatives to high-priced brand name drugs
into law.” Read CSRxP’s full statementHERE
<[link removed]>
.



Also, in case you missed it, a research article
<[link removed]> from
officials with the Centers for Medicare and Medicaid Services (CMS), published
in Health Affairs last week, highlights how Big Pharma’s egregious prescription
drug prices remain a major driver of U.S. health care spending. According to
the report, retail prescription drug spending increased 7.9 percent in the
United States in 2024, totaling $467 billion. The increase in retail
prescription drug spending was even larger when looking at just the Medicare
Part D program, with a 12.9 percent increase in spending on prescription drugs.
Read more on the new research article from Health AffairsHERE
<[link removed]>.



QUOTES OF THE WEEK



“Big pharma maintains that its list prices are a direct reflection of their
innovation costs, but these claims do not hold up upon further scrutiny. A 2022
study in the Journal of the American Medical Association revealed that out of
63 drugs—one-fifth of the drugs the FDA approved between 2009 and 2018 — ‘there
was no association between estimated R&D investments and treatment costs based
on list prices at the launch of the product or based on net prices a year after
launch.’”



David C. Datelle, Former Economist, U.S. Congress Joint Economic Committee
<[link removed]>



DATA POINTS YOU SHOULD KNOW



$2.67 Billion



The combined total spend of the top ten Big Pharma advertisers to air their TV
advertisements in 2025, according to ananalysis
<[link removed]>
from Fierce Pharma.



TWEETS OF THE WEEK



@FrankLuntz <[link removed]>:
“Pharmaceutical companies have raised prices on hundreds of drugs so far in
January, ushering in 2026 with steeper costs for everything from the COVID
vaccine to Ozempic. Companies hiked prices on 850 drugs by a median +4% over
2025 prices.”



@P4AD_ <[link removed]>: “According to
recent reporting from @Reuters, the median price of prescription drugs has
jumped from over $180,000 in 2021 to a staggering $370,000 today! While 1 in 3
Americans are already unable to access their prescription medications due to
cost, Big Pharma continues to prioritize profit and greed over patient lives.
Learn how we're fighting back athttp://FightPharma.org <[link removed]>
.”



ROAD TO RECOVERY



JAMA Network: Out-Of-Pocket Spending For Biologic Drugs After Biosimilar
Competition For Medicare Patients
<[link removed]>



Biologics—complex medications derived from living organisms—treat many
different conditions and are a major source of spending in the US. While
biologics represent a small share of prescription drugs used in the US, they
accounted for nearly half of US prescription drug spending in 2021. This
disproportionate spending is driven by high prices, which are made possible
because patent protection allows biologic drug makers to set monopoly prices.
To address increasing spending on biologics, in 2009 Congress authorized an
expedited US Food and Drug Administration (FDA) pathway to facilitate
competition by biosimilars, which are comparable alternatives to original
biologics made by different manufacturers. The goal was for biosimilar
competition to lower costs for patients and the health care system, like
generic competition has done for small-molecule drugs. Early biosimilars were
priced 15% to 45% lower than the originator biologic. In some cases, this
competition also led to lower prices for the originator biologics.



Drug Store News: Pharmacy, Health Orgs Join Biosimilars Council, AAM In
Supporting Interchangeablity Legislation
<[link removed]>



The Biosimilars Council and the Association for Accessible Medicines sent a
follow up letter to U.S. Senate and House health committee leaders in support
of the Biosimilar Red Tape Elimination Act. The letter was signed by over three
dozen leading advocacy groups representing health care, patients, consumers,
employers, taxpayers and policy think tanks. The group sent a letter of support
this past July. Since then, bicameral, bipartisan legislation has been
introduced and FDA Commissioner Marty Makary announced plans to finalize
guidance eliminating the requirement for switching studies and reiterated the
FDA’s recommendation that Congress remove this unnecessary distinction.



PHARMA’S POOR PROGNOSIS



USA Today: Drugmakers Hike Medicine Prices In 2026. How Much More Will You
Spend?
<[link removed]>



Pharmaceutical companies hiked prices on hundreds of drugs so far in January,
ushering in 2026 with steeper costs for everything from the COVID-19 vaccine to
Ozempic despite the Trump administration's efforts to bolster affordability.
Companies raised list prices on more than 850 drugs by a median 4% over 2025
prices, according to data from 46brooklyn Research, a drug pricing nonprofit.
The changes implemented as of Jan. 9 are on par with the amount drug companies
raised prices in 2025. List prices typically are not how much consumers pay at
the pharmacy counter or for mail order prescriptions. Factors such as rebates,
insurance discounts and copayments, deductibles and coinsurance all determine
how much people must spend to pick up prescriptions.



CT Insider: Big Pharma Doesn't Need To Charge Exorbitant Prices For Medical
Innovation
<[link removed]>



For over a decade both parties in Congress have been promising to lower the
price of prescription drugs for the American consumer. Despite all the
protestations by Democrats and Republicans about lowering prescription drug
prices, according to a 2024 study, gross prices for all drugs in the U.S. were
278% higher than the average in other countries and brand-name prescription
drugs were 422% of the norm in other countries globally.



PharmaVoice: Lilly, Takeda Targeted By Legal Strategy Usually Reserved For The
Mob
<[link removed]>



A potentially paradigm-changing lawsuit targeting Eli Lilly and Takeda
Pharmaceuticals has cleared a major hurdle and could wind up being decided in a
courtroom. If the case reaches trial, it would become the first non-settlement
lawsuit targeting pharma with the Racketeer Influenced and Corrupt
Organizations Act (RICO) pathway, normally reserved for mobsters. Wisner Baum,
which filed the case, is chasing damages as high as $7 billion, alleging that
the companies conspired to hide evidence their diabetes drug Actos was linked
to a higher risk of bladder cancer to maintain blockbuster profits.



###





























Copyright © 2019 Campaign for Sustainable Rx Pricing
Our address is 1341 G St NW, #1100, Washington, DC xxxxxx


This email was sent to [email protected]. To unsubscribe please click
here.
<[link removed]>