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Official urges 'America First' approach to bring generic manufacturing and APIs to U.S.
Summary
During opening remarks, the agency official said GDUFA negotiations should reward manufacturers that produce generics and APIs in the United States through user-fee incentives.
The speaker discussed ongoing negotiations over the Generic Drug User Fee Amendments (GDUFA), stating an interest in an "America First" approach to bring more generic drug manufacturing and active pharmaceutical ingredients (APIs) to the United States.
"On the GDUFA legislation that is being discussed right now, we're very open and honest about the fact that we would like to see an America 1st strategy to bring more generic manufacturing to The United States," the agency official said. The speaker said teams negotiating user fees were being asked to reward companies that manufacture within the U.S.
No specific legislative text or proposed user-fee amounts were cited during the remarks; the speaker described a policy preference and a desire to incentivize domestic production through the user-fee program.
