Billionaire entrepreneur Mark Cuban has urged Donald Trump’s administration to scrap the high regulatory fees charged by the USA Food and Drug Administration (FDA) for generic drug approvals. According to Cuban, the nearly US $360,000 fee per application creates a major financial barrier for companies looking to manufacture generics in the United States. Because many medications require hundreds of filings, the total cost runs into tens of millions of dollars, making domestic production unviable.

Cuban said his company, Cost Plus Drugs, is prepared to begin manufacturing generic medicines in the USA if these fees are waived. The move aligns with Trump’s broader agenda of bringing pharmaceutical manufacturing back to American soil. Several drug companies have already announced significant USA investments, and reducing regulatory expenses could accelerate this shift.

He added that Cost Plus Drugs would prioritise producing high-cost generics and medicines for rare diseases, offering them directly to consumers at more affordable prices. Supporters of the proposal argue that eliminating FDA application fees could boost domestic manufacturing capacity, reduce shortages, and lower drug costs for patients. However, some critics warn that removing user fees could affect the FDA’s ability to finance essential regulatory activities.

If implemented, Cuban’s proposal could significantly change the USA generics landscape by encouraging large-scale manufacturing investments and improving access to affordable medications.