President Donald Trump has been successful in convincing many of the world’s top drugmakers to commit to manufacturing more of their prescription treatments in the U.S.
But what about the onshoring of generic drugs?
Mark Cuban, co-founder of online pharmacy Cost Plus Drugs, contends his company would produce its generics in the U.S. if the FDA eliminated the fees required to secure an approved abbreviated new drug application.
“(It’s) the only thing holding us back,” Cuban said at the 2025 Forbes Healthcare Summit on Thursday. “Each one of those effectively costs through the FDA about $365,000. And so, if we want to add 100 drugs, that’s $36.5 million.”
Cost Plus, which was launched three years ago to bypass middlemen and lower the price of drugs, now carries 2,500 medications. For consumers, the price of each drug includes a 15% markup as a profit margin and a $5 shipping fee. Patients who are underinsured or uninsured can gain the most savings from the company’s products.
Cuban said Thursday that he is looking to manufacture 100 generic treatments in the U.S. and eventually work up to 1,000. Cost Plus also is eyeing biosimilars, Cuban said.
“If we're able to get that support from the FDA, and I can't say whether we will or not, but I know they're at least discussing it, then you will see most generics from us made here in the USA,” Cuban said.
The billionaire entrepreneur said that if FDA fees were eliminated, his company could begin producing generic drugs in the U.S. in less than a year. He pointed out that the Dallas-based company would not need to build a “huge factory to expand” because of its reliance on modular manufacturing, artificial intelligence and robotics.
“We’ve been able to make those modular pods so efficient that when even if we buy APIs—the advanced pharmaceutical ingredients overseas—we’re going to be able to make generic tablets cheaper than what we can buy from overseas.”
In an arrangement that was announced recently, Cost Plus has partnered with TrumpRx, a direct-to-consumer website where users will be able to directly purchase prescription medications rather than through insurance. Cuban that domestically manufactured products offered on both platforms would be identified online with American flags.
Cuban added his push to waive FDA fees is not an effort to evade regulatory controls.
“They can open up an office in our building, we don't care. They can be there. 24/7,” Cuban said. “It’s just these are fees that, you know, just make manufacturing uneconomical.”