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FDA's program to speed up drug approval shaved nearly a year off the process

Melissa Healy, Los Angeles Times on

Published in Business News

The Trump administration has proposed to slash FDA funding by $854 million in 2018, but recoup that loss with revenues from drug and medical device makers who pay fees to have their products evaluated. That proposal has hit head winds in Congress.

The likely result: With growing backlogs of generic and new drugs to be evaluated, the FDA may see personnel cuts, not an expansion.

"We've constantly cut the budget and reduced personnel costs at FDA, and this research suggests it might help to get more people there," said Dudley, who directs UCSF's Center for Healthcare Value.

If giving drug candidates a speedier path through the FDA is a priority, staffing the agency for the more labor intensive task will have to come first, said Dudley.

"It's just a choice we make as a society," Dudley added. "Is it worth it to hire people who are good at testing drugs and deciding whether they work, or is it something we don't want to pay for?"

 

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