September 26, 2025
TOPLINE
In case you missed it, a recent analysis found Big Pharma promptly admitted more than 40 patents on brand name prescription drugs were shams after the most recent round of challenges from the Federal Trade Commission (FTC), highlighting the scale of Big Pharma’s patent thickets on top money-makers.
The FTC issued its latest series of challenges to the validity of prescription drug patents in the U.S. Food and Drug Administration’s (FDA) Orange Book in May. According to an analysis from Competition Dynamics, Inc, published in Law360, Big Pharma companies responded by delisting 41 unique patents — essentially admitting that dozens of the challenged patents were so baseless they weren’t even worth an attempted defense.
Among the delistings were patents on blockbuster GLP-1 drugs—like Novo Nordisk’s Ozempic and Saxenda and AstraZeneca’s Bydureon—and COPD inhalers like AstraZeneca’s Symbicort, GSK’s Anoro Ellipta and Incruse Ellipta and Boehringer Ingelheim’s Striverdi Respimat.
To stop Big Pharma from gaming the system to keep drug prices high, Congress must advance bipartisan, market-based solutions, like The Affordable Prescriptions for Patients Act (S. 1041), and additional solutions to foster greater competition in the market. Read more HERE.
QUOTES OF THE WEEK
“This common-sense legislation will allow companies working to bring lower-cost generics to market clarity from the FDA on whether or not their drug is qualitatively and quantitatively the same as the list of drugs. What this means is that Americans and their companies can face less hurdles when they’re bringing a generic drug to market… Generic medicines are safe, effective and often far cheaper than our branded counterparts. Increased access to these medications will save Americans money at the pharmacy and also promote their health and well-being.”
U.S. Representative Neal Dunn (R-FL-02)
DATA POINTS YOU SHOULD KNOW
$3.1 Trillion
The amount of savings to the healthcare system from generic and biosimilars over the last decade, according to a white paper from the Association for Accessible Medicines.
TWEETS OF THE WEEK
@HHSGov: “Direct-to-consumer drug ads can push people to take drugs they don’t actually need. Americans often end up harmed instead of helped—that’s why @POTUS and @SecKennedy are taking action.”
@RepGregLandsman: “We have to get the cost of Rx drugs down…here’s one way: Let doctors swap in safe, lower-cost, similar versions of medicines like insulin, arthritis drugs, and cancer treatments so folks can get the care they need for less - which is what our new bipartisan bill does. https://t.co/70rhmZHRS2”
ROAD TO RECOVERY
Inside Health Policy: CSRxP: Lawmakers Advance Solution To Foster Greater Rx Competition
On Wednesday, the U.S. House Committee on Energy and Commerce held a markup on bipartisan legislation that would increase transparency in generic drug applications (H.R.1843). This bipartisan, market-based solution, sponsored by U.S. Representatives Neal Dunn (R-FL-02) and Kevin Mullin (D-CA-15), would reform Q1/Q2 sameness requirements from the U.S. Food and Drug Administration (FDA) that Big Pharma abuses to extend exclusivity, promoting a more efficient and streamlined generic drug approval process.
The Wall Street Journal: How The FDA Is Taking Aim At The Surreal World Of TV Drug Ads
The surreal world of TV pharmaceutical ads, where people with terrible diseases tend to be young, beautiful and living life to the fullest—sometimes with animated monsters—has been parodied on late night sketch comedy shows. But the drug industry’s biggest critic may turn out to be government regulators inside the Food and Drug Administration. The FDA is cracking down on direct-to-consumer ads on the directive of President Trump.
RealClearHealth: Opinion: Republicans Should Lead The Charge To Stop Big Pharma’s Patent Games
When Congress passed the Hatch-Waxman Act in 1984, it was a model of smart policymaking. The law struck a careful balance, maintaining patent protections to reward pharmaceutical innovators for undertaking the risks of drug development, while ensuring that once patents expired, lower-cost generics could quickly reach the market. The framework it established worked for decades, fueling innovation and saving American patients billions. But that framework has been hijacked by Big Pharma’s newest innovation: serial patent litigation. A new white paper from the Association for Accessible Medicines and the Biosimilars Council details how.
PHARMA’S POOR PROGNOSIS
The New York Times: A New Shot For Cancer Is Convenient, But Poised To Keep Prices High
The cancer medication Keytruda is the world’s best-selling drug. But with lower-priced competition set to arrive as soon as 2028, Keytruda’s manufacturer, Merck, is on the brink of losing tens of billions of dollars in sales. To keep Keytruda revenue flowing, Merck followed a well-worn playbook. It developed a new version of the drug, given as a shot under the skin, which the Food and Drug Administration approved on Friday. The company is talking up the new version as quicker and easier for patients than the original therapy, which is given through tubes as an intravenous infusion.
Fox News: Watch: Parody Drug Ad Spotlights RFK’s Crackdown On Misleading Pharmaceutical Marketing
Shortly after announcing a strategy to go after deceptive direct-to-consumer advertising by the pharmaceutical industry, Robert F. Kennedy Jr. and the Department of Health and Human Services released a parody video of a drug advertisement, a pointed way of emphasizing the fact that the United States is largely unique in allowing drug ads. "Tired of endless drug ads promising quick fixes but leaving you sicker than you were before? That can change today. Ask your doctor about MAHA," the parody commercial begins, referring to Kennedy's "Make America Healthy Again" initiative. "MAHA may cause healthier living, fewer chronic diseases and lower drug costs," the video's narrator continues. "Some Americans reported more time spent with family instead of at the pharmacy. Other side effects may include healthier children, a stronger nation, more transparency in healthcare, honest advertising and accountability from Big Pharma."
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