June 12, 2026
TOPLINE
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, including the Biosimilar Red Tape Elimination Act (S. 1954), the Medication Affordability and Patent Integrity Act (S. 2658) and the Ensuring Timely Access to Generics Act (S. 3014).
- The Biosimilar Red Tape Elimination Act (S. 1954) would eliminate outdated U.S. Food and Drug Administration (FDA) requirements and modernize the drug approval process to expedite biosimilar substitution and increase competition from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 system here.
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
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: “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: “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
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?
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
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.
###