September 19, 2025
TOPLINE
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. We applaud the committee for voting to advance this solution to help foster greater competition from more affordable alternatives to high-priced brand name drugs that the nonpartisan Congressional Budget Office (CBO) estimates would deliver more than $1 billion in savings. Read more HERE.
And, in case you missed it, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary wrote an op-ed, published in The New York Times this previous weekend, detailing how Big Pharma’s staggering spending on advertising directly targeting consumers misleads American patients and increases prescription drug spending. Commissioner Makary also called for reforms and highlighted the bipartisan momentum to hold brand name drug companies accountable.
The Administration and lawmakers, on both sides of the aisle, are right to be applying greater scrutiny to the pharmaceutical industry’s aggressive marketing practices in the U.S. and their impact on drug prices — and supporting solutions to hold Big Pharma accountable for staggering spending on DTC advertising of high-priced brand name prescription drugs. Read more HERE.
QUOTES OF THE WEEK
“Whether driven by patient protection concerns or fiscal responsibility principles, lawmakers across the political spectrum recognize that America’s unique position as one of only two countries allowing widespread prescription drug advertising demands serious reform… The billions of dollars drug companies spend on advertising would be better spent on lowering drug prices for American consumers.”
FDA Commissioner Marty Makary
DATA POINTS YOU SHOULD KNOW
$23.5 Million
Johnson & Johnson’s estimated advertising spend in August on just one blockbuster drug, Tremfya, according to a report from MM+M.
TWEETS OF THE WEEK
@DrMakaryFDA: “Pharma companies spend 20-25% of their budgets on ‘marketing.’ TV ads alone cost them >$10 billion that could be better spent on lowering drug prices for everyday Americans. https://www.nytimes.com/2025/09/13/opinion/i-run-the-fda-pharma-ads-are-hurting-americans.html”
@Runaway_Rx: “A recent Reuters analysis found that in 2021, the median annual list price of a new drug was $180,000. In 2024, it was over $370,000. 🤯 That’s double the price in just 4 years! Read more in @Reuters #TheProblemIsThePrice https://reut.rs/4m6hMPn”
ROAD TO RECOVERY
The New York Times: Opinion: I Run The F.D.A. Pharma Ads Are Hurting Americans.
American drug advertisements are filled with dancing patients, glowing smiles and catchy jingles that drown out the fine print. It’s not education — it’s distraction by design. This is not how the practice of medicine is supposed to be. Earlier this week, President Trump and the Food and Drug Administration took action to rein in misleading pharmaceutical ads targeted at consumers. An existing F.D.A. regulation states that ads must not create a “misleading impression,” and that ads must offer a “fair balance” between a drug’s benefits and risks. But many ads today do not abide by these standards. In fact, the most common message seems to be that a drug will instantly transform you to be singing and dancing endlessly.
JAMA Network: The FDA’s Overdue Crackdown On Misleading Pharmaceutical Advertisements
Direct-to-consumer pharmaceutical advertising has evolved into a public health crisis demanding immediate action by the US Food and Drug Administration (FDA). For nearly 3 decades, pharmaceutical companies have exploited weak enforcement, flooding US consumers with promotional content that is often misleading. The US is one of only 2 countries worldwide that permits direct-to-consumer pharmaceutical advertising. A 1997 regulatory change by the FDA made these advertisements more widespread by relaxing restrictions, unleashing a marketing free-for-all. The consequences of this regulatory failure have been significant.
Bloomberg: Opinion: This Crackdown On Drug Ads Is Long Overdue
The Trump administration’s crackdown on pharmaceutical ads is a welcome step toward lessening Big Pharma’s influence over conversations between patients and their doctors. Americans are among the few people in the world bombarded with advertisements for medications most of us don’t need — New Zealand is the only other country that allows direct-to-consumer drug advertising. These policies have given pharmaceutical companies significant influence over consumer behavior when it comes to health.
PHARMA’S POOR PROGNOSIS
The Well News: Opinion: To Lower Drug Prices, Conservatives Must Tackle Patent Abuse
Prescription drugs have become unaffordable. The Department of Health and Human Services found that spending on medications increased by $83 billion from 2016 to 2021, and 14% of Medicare beneficiaries now skip filling prescriptions they can’t afford… Conservatives must target the root cause of skyrocketing drug prices: the lack of competition in the prescription drug market, a market defined by rent-seeking and monopolistic practices. Drug companies exploit loopholes in the patent and regulatory system to keep prices high. They file excessive patents, “patent thicketing,” to deter generic competitors, make minor drug tweaks, “evergreening,” to extend patents, and use Food and Drug Administration provisions to delay competition. This means stronger monopolies, higher prices and limited access.
RealClearHealth: Biosimilars Are The Future Of Medicine
Health care in the United States sits at the crux of a frustrating truth; it is the home of some of the newest and best forms of treatment and services that are saving countless lives, but it is also exorbitantly expensive in a way that is simply unsustainable for our economy and for patients. For decades, the U.S. has shouldered the burden of expense for the rest of the world’s continually developing health care practices, and the strain is showing. We must take a careful look at where changes can be made that will reduce costs without impacting the quality of care we provide. An easy starting point where the Trump administration has already shown leadership is supporting the increased uptake of biosimilars.
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