On Tuesday, JAMA Network published a Viewpoint article from Commissioner of the
U.S. Food and Drug Administration (FDA) Marty Makary and Director of the FDA’s
Center for Biologics Evaluation and Research (CBER) Vinay Prasad outlining the
new administration’s priorities for the agency, and placing particular emphasis
on addressing “[t]he high price of drugs in the U.S.” by fostering greater
generic and biosimilar competition.
June 13, 2025
TOPLINE
On Tuesday, JAMA Network
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Viewpoint article from Commissioner of the U.S. Food and Drug Administration
(FDA) Marty Makary and Director of the FDA’s Center for Biologics Evaluation
and Research (CBER) Vinay Prasad outlining the new administration’s priorities
for the agency, and placing particular emphasis on addressing “[t]he high price
of drugs in the U.S.” by fostering greater generic and biosimilar competition.
“The high price of drugs in the US relative to other Organization for Economic
Co-operation and Development nations represents a great American rip-off,”
Makary and Prasad write. “The FDA will use its power to address costs. These
include expediting generic medications and massively streamlining the burden to
develop biosimilar compounds.”
Read more on Big Pharma’s anti-competitive practices that block competition
from more affordable alternatives to high-priced brand name drugsHERE
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. And read more on how biosimilar competition effectively delivers savingsHERE
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.
Makary and Prasad also preempted Big Pharma’s common argument that high prices
are justified by investments in research and development (R&D), noting, “[mo]st
large pharmaceutical companies spend more on marketing, including
direct-to-consumer advertisements that can be misleading, than they spend on
research and development.”
Earlier this year, The Campaign for Sustainable Rx Pricing (CSRxP) released an
analysis
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that showed 10 of the largest pharmaceutical companies spent a combined $13.8
billion on advertising and promotion (A&P) in 2023 alone in the U.S. The
analysis found taxing or prohibiting DTC ads for the ten largest pharmaceutical
companies in the U.S. would result in increased federal tax revenue between
$1.5 and $1.7 billion per year. Read the full analysisHERE
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.
QUOTE OF THE WEEK
“The price of medicine should not be a secret. Disclosing the price of
prescription drugs in advertisements will empower patients to make informed
decisions and ultimately lead to lower health care costs. Not only will it
increase competition, it will ultimately empower Americans to make the best
decisions for their health and budget.”
- U.S. Representative Dave Taylor (OH-02)
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“For years, Big Pharma has poured billions of dollars into advertisements to
push overpriced prescription drugs on consumers. The United States is one of
just two countries in the world that allows pharmaceutical companies to
advertise directly to patients. These heavily advertised drugs are often some
of the most expensive on the market, driving huge costs on patients. Consumers
deserve to know the price of a product before they buy it.”
U.S. Representative Jan Schakowsky (IL-09)
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DATA POINTS YOU SHOULD KNOW
$233.6 Million
The combined advertising spend from the ten highest-spending Big Pharma giants
in just the one month of April 2025, according to anarticle
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from Fierce Pharma.
TWEETS OF THE WEEK
@IMAKglobal <[link removed]>: “I go to
pick up my Rybelsus and it’s $425” Novo Nordisk, the drug company behind the
popular GLP-1 drug Rybelsus, is gaming the patent system to monopolize the
semaglutide market. The company’s abusive patenting schemes generate billions
in revenue, much of which is used to boost its stock price and enrich its
shareholders.”
@P4ADNOW <[link removed]>: “Humira’s 132
patents delayed competition for years—keeping prices high while patients paid
the price. Pharma’s patent abuse blocks access to affordable medications.
Reforming the system is essential to lower costs.”
ROAD TO RECOVERY
Inside Health Policy: CSRxP Applauds U.S. Senate Reintroduction Of Bipartisan
Solution To Promote Greater Biosimilar Competition In The Prescription Drug
Market
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The Campaign for Sustainable Rx Pricing (CSRxP) issued the following statement
Friday on the introduction of the “Biosimilar Red Tape Elimination Act”
(S.1954) in the U.S. Senate. “CSRxP commends Senators Lee (R-UT), Paul (R-KY),
Hassan (D-NH) and Luján (D-NM) for supporting greater competition in the
prescription drug marketplace with the reintroduction of the bipartisan
Biosimilar Red Tape Elimination Act,” said CSRxP executive director Lauren
Aronson. “By eliminating outdated FDA requirements, this bipartisan,
market-based solution will help bring more biosimilars to market more quickly,
fostering greater competition from more affordable alternatives to high-priced
brand name drugs to help lower prices for patients, taxpayers and the U.S.
health system.”
Law360: Sens. Float Automatic Biosimilar Interchangeable Label
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A bipartisan group of U.S. senators has reintroduced legislation that would
reduce what the lawmakers called barriers to accessing lower-cost versions of
biologic drugs, making an adjustment to how biosimilars are deemed
interchangeable with their name-brand equivalents. The Biosimilar Red Tape
Elimination Act, introduced on Wednesday by Sen. Mike Lee, R-Utah, and
co-sponsored by Sens. Rand Paul, R-Ky., Maggie Hassan, D-N.H. and Ben Ray
Luján, D-N.M., would make it so that biosimilars are automatically deemed
interchangeable with their name-brand biologic counterparts.
The Highland County Press: Congressman Taylor Introduces Bill Requiring Price
Transparency For Prescription Drugs
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Congressman Dave Taylor (OH-02) and Congresswoman Jan Schakowsky (IL-09) today
introduced the bipartisan Drug-price Transparency for Consumers Act of 2025,
which would require drug companies to include the list price of prescription
drugs in all direct-to-consumer (DTC) advertisements… “CSRxP commends Rep.
Taylor and Rep. Schakowsky for their introduction of a U.S. House companion to
the bipartisan Drug-price Transparency for Consumers (DTC) Act, that will help
deter price-gouging by requiring disclosure of the prices set by brand name
drug companies on blockbuster products in advertising directly targeting
consumers,” said a spokesperson from the Campaign for Sustainable Rx Pricing
(CSRxP)… AARP, the American Medical Association, the American Hospital
Association, Patients for Affordable Drugs Now, the American College of
Physicians, the American Academy of Neurology, and the Campaign for Sustainable
Rx Pricing are supporting organizations of this bill.
PHARMA’S POOR PROGNOSIS
Medscape: Medicare Part D Cancer Drug Launch Prices Soar Past Inflation
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Launch prices for Medicare Part D anticancer drugs have risen sharply since
2012, with a mean increase of $1694 per year. In 2025, the observed prices were
15%-200% higher than expected if the increases were due to inflation alone, but
the gap between observed and inflation-adjusted prices narrowed over the study
period.
Inside Health Policy: Makary, Prasad Plan New Pilot Program For Swifter Drug
Approvals
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FDA Commissioner Marty Makary and biologics center director Vinay Prasad laid
out their priorities for the agency in a Journal of the American Medical
Association article Tuesday (June 10), saying they will establish a new pilot
program to speed up drug approvals, aim to lower drug costs and use artificial
intelligence for drug investigations and postmarket surveillance … The article
also addresses the high cost of drugs. While FDA cannot consider price in
benefit-risk calculations, per statute, the officials say they want FDA to use
its power to address costs, such as through expediting generic medications and
streamlining the process for biosimilar developers.”
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