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 a statement. “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 statement HERE.
Also, in case you missed it, a research article 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 Affairs HERE.
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
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 an analysis from Fierce Pharma.
TWEETS OF THE WEEK
@FrankLuntz: “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_: “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 at http://FightPharma.org.”
ROAD TO RECOVERY
JAMA Network: Out-Of-Pocket Spending For Biologic Drugs After Biosimilar Competition For Medicare Patients
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
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?
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
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
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.
###
