The entrepreneur urges the Trump administration to eliminate costly FDA generic drug fees, part of a broader push to scale domestic production, address shortages, and challenge PBM-driven pricing models.
Mark Cuban has been encouraging the Trump administration to waive the hundreds of thousands of dollars in regulatory fees that often come with generic drug approvals, according to a Reuters report.1
The FDA’s fees for a generic drug approval application come out to
The reason for Cuban's push? With the billionaire being the co-founder of Cost Plus Drugs, an online pharmacy that strives to provide a cost-plus pricing model (charging the price of the drug plus a 15% markup), the company offers what many might call a transparent alternative to traditional PBMs. It also believes that it's more than capable of stepping into the generics arena.
These drug pricing discussions stem from previous dialogue between the two gentlemen, as this past October, at the HLTH conference’s keynote in Las Vegas, Cuban confirmed that his company would be collaborating with TrumpRx, President Trump’s direct purchasing platform.2
Cuban attributes the US’ high drug prices to PBMs—often considered the “middlemen” within the pharma supply chain—arguing that their rebate-driven model encourages inflated pricing by rewarding drugs with larger rebates instead of those that might be more affordable to patients.2
He’s also accused PBMs of pressuring independent pharmacies via what he describes as unfair reimbursement rates and aggressive audit tactics. That was why he started Cost Plus Drugs in 2022, a public benefit corporation that sells medication directly to consumers.
"There's no reason for us to manufacture a $4 drug that you get at Walmart, but if there's something that costs $100 or more, and we can manufacture it here and sell it for less, all the better," he told Reuters.
Cost Plus Drugs constructed a compounding pharmacy in Dallas, a 22,000 square-foot fill-finish facility built to address drug shortages by manufacturing sterile injectables.3 Cuban said that there is certainly potential for expansion of the plant within the year to produce generic drugs if the fees were to be waived.
The primary focus would be high-cost generics—such as rare disease drugs—along with the well-known generic drugs.
News has also been circulating concerning a potential partnership between Cost Plus Drugs and Humana—a health insurance company for older adults— in which the parties would collaborate on decreasing prescription drug costs for US employers. The initial focus, which was revealed yesterday at the Forbes Healthcare Summit,4 would be on direct-to-employer programs that circumvent traditional pharmacy benefit management companies.
• Cuban’s request to Trump: Urging the administration to waive costly FDA generic drug approval fees to accelerate US-based manufacturing.
• Cost Plus Drugs’ mission: A cost-plus pricing model (drug price + 15% markup) designed to bypass PBMs and reduce patient costs.
• New manufacturing footprint: A 22,000 square-foot Dallas compounding facility built to produce sterile injectables and address drug shortages.
Meanwhile, Trump has been on a mission to increase manufacturing in the US, specifically by enacting tariffs if pharma manufacturers refuse to comply. Compliance would signify that these drug producers show an intention/a plan to produce meds in the US with construction projects.
One recent example came from Novartis, who announced that it will be growing its North Carolina operations with the construction of a new site in Durham, including two new facilities that’ll prioritize biologics production, along with sterile packaging.5 The strategic investment represents only one component of the company’s greater mission to investment $23 billion over the next five years toward US infrastructure.
“This announcement is a commitment to American innovation and to the patients we serve,” said Vas Narasimhan, CEO of Novartis. “By building a full, end-to-end manufacturing presence in North Carolina for our broader portfolio, we are expanding our capacity to deliver medical breakthroughs, securing a more resilient US supply chain, and investing in the local communities that make our mission possible.”
References
1. Wingrove P. Mark Cuban Seeks Trump’s Backing for Drug Fee Relief To Spur Generics Manufacturing. Reuters. December 4, 2025. Accessed December 5, 2025.
2. Saraceno N. Mark Cuban Confirms Cost Plus Drugs Partnership. Pharmaceutical Commerce. October 22, 2025. Accessed December 5, 2025.
3. Landi H. Mark Cuban Says Cost Plus Drugs Targeting Generic Meds in Short Supply as It Opens Manufacturing Facility. Fierce Healthcare. March 4, 2024. Accessed December 5, 2025.
4. Japsen B. Humana and Mark Cuban’s Cost Plus Drugs Working on Partnership To Lower Prices. Forbes. December 4, 2025. Accessed December 5, 2025.
5. Saraceno N. Novartis Unveils Expansive North Carolina Manufacturing Hub to Strengthen US Drug Supply Chain. Pharmaceutical Commerce. November 20, 2025. Accessed December 5, 2025.
