The Real PDUFA Inflation Rate

20 Jul 2016

• By Michael McCaughan

The FDA/Industry agreement for PDUFA VI envisions a relatively modest increase in the amount of user fees paid by brand name companies; the length of the “commitment letter” outlining the agreement, however, expanded dramatically.

When the Prescription Drug User Fee program began in 1992, the fee set for each new drug application was $100,000. Twenty-five years later, the fee is almost $2.4 million.

PDUFA now generates over $800 million in revenues for FDA, more than 60% of the agency’s total spending on human...