The U.S. Senate Committee on Health, Education, Labor and Pensions (HELP)
announced a markup on Wednesday, June 17, with several bills scheduled for
consideration.
June 12, 2026
TOPLINE
The U.S. Senate Committee on Health, Education, Labor and Pensions (HELP)
announced amarkup
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on Wednesday, June 17, with several bills scheduled for consideration,
including the Biosimilar Red Tape Elimination Act (S. 1954
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Medication Affordability and Patent Integrity Act (S. 2658
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Ensuring Timely Access to Generics Act (S. 3014
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* The Biosimilar Red Tape Elimination Act (S. 1954) would eliminate outdated
U.S. Food and Drug Administration (FDA) requirements and modernize the drug
approval process to expedite biosimilar substitution and increase competition
from more affordable alternatives to high-priced brand name products.
* The Medication Affordability and Patent Integrity Act (S. 2658)would
strengthen coordination between the S. Patent and Trademark Office (USPTO) and
FDA by requiring more consistent information across agencies, helping improve
patent quality, reduce Big Pharma abuse of the patent system and prevent costly
delays in the availability of more affordable generics.
* The Ensuring Timely Access to Generics Act (S. 3014)would improve oversight
of the citizen petition process at the FDA, ensuring drugmakers can’t game the
system to stall generic competition and patients can benefit from lower-cost
alternatives sooner.
The Senate Committee on HELP should advance these solutions to help crack down
on Big Pharma’s egregious anti-competitive tactics and lower prices for
American consumers. Read more about how generic and biosimilar competition
lowers costs for patients, taxpayers and the U.S. health care systemhere
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.
QUOTE OF THE WEEK
“Patent thickets are most concerning in the pharmaceutical industry. There’s
no other industry in which the company can collect as many patents as it wants
just to keep competitors off the market.”
- Michael Carrier, Board of Governors Professor of Law, Rutgers Law School
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DATA POINTS YOU SHOULD KNOW
$115 Million
The amount the Congressional Budget Office (CBO) projects the Medication
Affordability and Patent Integrity Act (S. 2658) will save over 10 years due to
increased generic competition.
TWEETS OF THE WEEK
@realtahiramin <[link removed]>:
“Don’t worry if reading this makes your head spin. Uncovering a drug’s patent
portfolio is like trying to assemble a 1,000 piece puzzle where every piece is
hidden and the company that owns the puzzle has a multi-billion-dollar
incentive for you not to find any of them.”
@CAPPA_Rx <[link removed]>: “A new
blog from @RSI explores how Big Pharma’s “strategic gamesmanship” keeps
lower-cost competition out of the prescription drug market. As the piece puts
it, ‘brand manufacturers are weaponizing patents to limit competition and delay
entry rather than spur invention.’”
ROAD TO RECOVERY
PharmExec: U.S. Supreme Court Unanimously Votes In Favor of Hikma In Case
Against Amarin: Report
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The U.S. Supreme Court has ruled unanimously that Hikma Pharmaceuticals'
generic version of Amarin's cardiovascular drug Vascepa did not infringe
Amarin's patents… "This decision helps restore certainty to the skinny-label
pathway and will encourage more lower-cost generic competition to enter the
market more quickly," said Lauren Aronson, executive director of the Campaign
for Sustainable Rx Pricing, a group whose members include Blue Cross/Blue
Shield, CVS Health, Kaiser Permanente, and AARP.
The Hill: Opinion: Is This The End Of Costly And Harmful Pharmaceutical
Advertising?
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For more than two decades, Americans have lived with a peculiar feature of
their healthcare system: television commercials in which smiling actors jog
through sunlit parks, while a voice rapidly lists side effects ranging from
nausea to death. Direct-to-consumer pharmaceutical advertising has become so
normalized that it is easy to forget how unusual it is globally. The United
States is effectively the only country in the world that allows this practice.
Most advanced nations have concluded that prescription drugs are fundamentally
different from ordinary consumer products, and that medical decisions should be
guided by physicians and evidence — not billion-dollar advertising campaigns
designed to manufacture demand.
PHARMA’S POOR PROGNOSIS
Fierce Pharma: AstraZeneca Reprimanded Over LinkedIn Likes Once Again
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The LinkedIn activities of AstraZeneca employees have yet again landed the
drugmaker in hot water, with the U.K. marketing watchdog identifying eight
breaches of its rules in the latest of a series of cases. A health professional
triggered the latest case by alerting the U.K. self-regulatory body, the PMCPA,
to a LinkedIn post published by an independent organization. The post, which
announced an award for “Best Pharmaceutical Product,” called AstraZeneca’s
cancer drug Lynparza “groundbreaking.” The complainant alleged that U.K.-based
AstraZeneca employees, including senior staff, had interacted with the post.
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