June 13, 2025
TOPLINE
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.
“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 drugs HERE. And read more on how biosimilar competition effectively delivers savings HERE.
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 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 analysis HERE.
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)
“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)
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 an article from Fierce Pharma.
TWEETS OF THE WEEK
@IMAKglobal: “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: “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
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
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
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
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
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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