May 30, 2025
TOPLINE
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.
“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 a statement. “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 high HERE. Read more on bipartisan, market-based solutions to hold Big Pharma accountable HERE.
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)
DATA POINTS YOU SHOULD KNOW
11 Percent
The percentage of all national TV ad spending devoted to pharmaceutical advertising, according to an analysis from Bloomberg.
TWEETS OF THE WEEK
@realtahiramin: “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: “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
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
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
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
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
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
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.
###
