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).
September 19, 2025
TOPLINE
On Wednesday, the U.S. House Committee on Energy and Commerce held a markup
<[link removed]>
on bipartisan legislation that would increase transparency in generic drug
applications (H.R.1843
<[link removed]>).
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 moreHERE
<[link removed]>
.
And, in case you missed it, U.S. Food and Drug Administration (FDA)
Commissioner Marty Makary wrote an op-ed, published inThe New York Times
<[link removed]>
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
<[link removed]>
andlawmakers
<[link removed]>
, onboth
<[link removed]>
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 moreHERE
<[link removed]>
.
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
<[link removed]>
DATA POINTS YOU SHOULD KNOW
$23.5 Million
Johnson & Johnson’s estimated advertising spend in August on just one
blockbuster drug, Tremfya, according to areport
<[link removed]>
from MM+M.
TWEETS OF THE WEEK
@DrMakaryFDA <[link removed]>: “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.
[link removed]
<[link removed]>
”
@Runaway_Rx <[link removed]>: “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 #TheProblemIsThePricehttps://reut.rs/4m6hMPn
<[link removed]>”
ROAD TO RECOVERY
The New York Times: Opinion: I Run The F.D.A. Pharma Ads Are Hurting Americans.
<[link removed]>
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 <[link removed]>
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
<[link removed]>
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
<[link removed]>
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
<[link removed]>
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.
###
Copyright © 2019 Campaign for Sustainable Rx Pricing
Our address is 1341 G St NW, #1100, Washington, DC xxxxxx
This email was sent to
[email protected]. To unsubscribe please click
here.
<[link removed]>
