In case you missed it, The Federal Trade Commission (FTC) recently announced it
would challenge the validity of more than 200 patents on brand name
prescription drugs listed in the U.S. Food and Drug Administration (FDA)’s
Orange Book.





 

May 30, 2025



TOPLINE



In case you missed it, The Federal Trade Commission (FTC) recently announced
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it would challenge the validity of more than 200 patents on brand name
prescription drugs listed in the U.S. Food and Drug Administration (FDA)’s
Orange Book.



“CSRxP commends the Administration for continuing the FTC’s crackdown on Big
Pharma’s sham patents in the Orange Book that block competition from more
affordable alternatives to high-priced brand name drugs,” said CSRxP executive
director Lauren Aronson in astatement
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. “By challenging sham patents, building on positive progress to better
coordinate among agencies and advancing bipartisan, market-based solutions in
Congress to hold Big Pharma accountable for anti-competitive practices,
policymakers in Washington can deliver greater competition in the prescription
drug marketplace and lower prices for the American people.”



Learn more on Big Pharma’s patent abuse that blocks competition and keeps drug
prices highHERE
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. Read more on bipartisan, market-based solutions to hold Big Pharma accountable
HERE <[link removed]>.



QUOTE OF THE WEEK



“Drug manufacturers in the United States spend approximately $6 billion
annually in

direct-to-consumer (DTC) prescription drug advertisements, with approximately
one-third of all

commercial time across evening news programs consumed with these pharmaceutical

promotions. It is a similar story when consumers stream their favorite show or
scroll through

social media. The United States is one of only two developed countries in the
world that permit

such pharmaceutical commercials.”



- United States Senator Dick Durbin (D-IL)
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DATA POINTS YOU SHOULD KNOW



11 Percent



The percentage of all national TV ad spending devoted to pharmaceutical
advertising, according to ananalysis
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from Bloomberg.



TWEETS OF THE WEEK



@realtahiramin <[link removed]>: “An
internal Celgene presentation from 2014. Celgene’s primary patent on Revlimd
expired in 2019. Despite that, Celgene estimated it had a 65% chance of
extending its Revlimid monopoly in the U.S. until 2026.”



@IMAKglobal <[link removed]>: “NEWS: The
@FTC renews challenge of more than 200 improper patent listings. ‘Continuing
its efforts to promote competition and lower drug prices, today the Federal
Trade Commission renewed its challenges against dozens of improperly listed
device patents that shield brand-name asthma, diabetes, epinephrine
autoinjector, and COPD drugs from prompt generic competition. Improper patent
listings can delay generic alternatives from entering the market, keeping drug
prices artificially high and preventing patients from accessing lower cost
drugs.’”



ROAD TO RECOVERY



Inside Health Policy: Makary Signals Support For Biosimilar Interchangeability
Reform
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FDA Commissioner Marty Makary signaled his support to streamline the approval
and uptake of biosimilar drugs in his first appearance before Congress as
commissioner Thursday (May 22), including reconsideration of removing the
controversial "interchangeability" designation that industry experts say has
hindered competition and kept drug prices high. The United States remains the
only country in the world with a distinct regulatory designation for
"interchangeability" when it comes to biosimilars--a requirement that has been
criticized as both scientifically unnecessary and a barrier to market access.



Inside Health Policy: ICER Preps For Inaugural Annual Report On Drug List
Prices & Access
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The Institute for Clinical and Economic Review on Monday (May 19) released a
protocol detailing how it plans to gather information for a new report on
prescription drug list prices and the barriers patients face when trying to
access their medications. The drug pricing watchdog will evaluate the launch
prices of brand drugs approved by the FDA from the start of 2022 through to the
end of 2024 and will specifically analyze trends related to both list and net
prices, determine whether prices align with the health benefits a drug provides
to patients, and evaluate data on coverage restrictions, patient cost-sharing
and patient experiences with accessibility.



AARP: AARP Takes On High Rx Prices
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For too long, Americans have paid the highest prices in the world for
medicine. That’s why, a few years ago, AARP launched a massive campaign to take
on the most powerful special interest group in Washington: the big drug
companies. I’m proud to say we won—maybe the first time anyone has beat the
drug companies—and helped pass a groundbreaking new prescription drug law that
is finally providing relief for millions of older Americans.



PHARMA’S POOR PROGNOSIS



Bloomberg: Cancer Drugs Cost More Than Ever. They Often Don’t Extend Lives
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The moment she heard that her mother, then 67, had advanced breast cancer,
Stacie Dusetzina began hunting for potential treatments. A cancer policy
researcher at Vanderbilt University, Dusetzina knew the go-to drug in many
cases was Pfizer Inc.’s Ibrance. She learned it might cost her mother, who
lived on a fixed income, around $10,000 out of pocket annually. Medicare,
required by law to cover cancer treatment, would have paid much of the rest of
the cost. At the time, in 2020, the pill listed for a jaw-dropping $160,000 a
year, rising more recently to $214,000.



Medical Bag: Cancer Drug Prices Continue to Rise, Outpacing Inflation
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The prices charged at the US launch of targeted cancer therapies have
increased well above the rate of inflation every year since 2012, according to
research published in JAMA. Researchers used the US Food and Drug
Administration’s Orange Book to identify branded, self-administered,
molecularly targeted cancer therapies that were approved between January 2010
and December 2024.



…The analysis included 86 targeted cancer therapies. The mean monthly launch
price increased from $10,954 for drugs first recorded by Medicare in 2012-2014
to $27,891 for drugs first recorded in 2023-2025. The researchers calculated
that, after adjusting for inflation, mean launch prices increased by $1694 per
year during 2012-2024 (P <.001), with no “notable” differences between earlier
and later study periods.



Endpoints News: Teva, Novartis Get Fresh Warnings From FTC Over Orange Book
Patent Listings
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The FTC is continuing its campaign against drug patents that it claims are
improperly listed in an FDA database known as the Orange Book, carrying over an
approach started under the Biden administration. The antitrust regulator on
Wednesday sent a fresh round of warning letters to three Teva entities,
Novartis, Amphastar Pharmaceuticals, Viatris’ Mylan Specialty, and Covis
Pharma. The letters allege that the companies failed to remove “improperly
listed device patents” that cover treatments for asthma, diabetes and more from
the patent database.



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