Mark Cuban speaks during a hearing called "Modernizing Health Care: How Shoppable Services Improve Outcomes and Lower Costs" by the U.S. Senate Special Committee on Aging in Washington, D.C., U.S., October 22, 2025. REUTERS/Kylie Cooper

By Patrick Wingrove

Dec 4 (Reuters) - Billionaire Mark Cuban has urged the Trump administration to waive the hundreds of thousands of dollars in regulatory fees required for generic drug approvals, he told Reuters on Wednesday.

Cost Plus Drugs, an online pharmacy Cuban launched to sell drugs directly to customers at low prices, would start U.S. manufacturing of certain generic medicines if the fees were scrapped, he said.

U.S. President Donald Trump, who campaigned on a promise to boost domestic manufacturing, has vowed this year to bring the production of pharmaceuticals and their key ingredients back to American soil.

Drugmakers have in response pledged to invest hundreds of billions of dollars collectively to expand their U.S. manufacturing and have committed to lowering prices for several of their branded drugs to avoid potential tariffs.

Cuban said one of the biggest barriers to U.S. manufacturing of generic drugs - medicines that have gone off patent and can be produced by any company at scale - is the high fees the U.S. Food and Drug Administration charges to approve them.

"When you're trying to manufacture hundreds of medications and get approvals for them, it costs tens of millions of dollars, and that destroys the economics of moving manufacturing from overseas to here," he said.

The U.S. Food and Drug Administration charges nearly $360,000 per application to approve a generic drug, according to its website.

Cuban said Cost Plus Drugs, which already runs a major compounding pharmacy producing sterile injectables and other hospital drugs, could expand its Dallas, Texas facilities within a year to make generic drugs if the policy change goes through.

He said the company would target high-cost generics, including for rare disease drugs that can cost hundreds of thousands of dollars, as well as highly popular generic medicines.

"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 said.

The company currently aims to drive down the cost of drugs broadly by selling them at a 15% markup over its cost, plus pharmacy fees. While some insured patients can use their benefits on the website, the biggest savings from the pharmacy are currently for uninsured and underinsured people.

Cuban, who has repeatedly called for greater transparency in healthcare pricing and the practices of middlemen who negotiate rebates with drugmakers, said the company also plans to launch a service publishing its contracts with providers as a benchmark for others.

He earlier this year said Cost Plus Drugs would participate in TrumpRx, a government-backed website designed to lower prescription drug costs by connecting patients directly with pharmaceutical manufacturers.

(Reporting by Patrick Wingrove in New York; Editing by Lincoln Feast.)