The bill would require the drug industry to pay the FDA more than $700 million in fiscal 2013 and higher amounts in subsequent years in exchange for a commitment that the FDA meet certain performance goals regarding the timely review of drug applications; increase the interaction between drug sponsors and the FDA during the review process; improve interactions with patients, particularly those with rare diseases; provide more data to improve transparency; and undergo an independent assessment from a third party about the agency's review of applications for novel drugs.
Meanwhile, the device industry would pay about $595 million in user fees from fiscal 2013-2017 to guarantee changes in the FDA's performance and accountability. Some of these changes would require the FDA to report its total time for reviewing devices and also require the agency to implement a corrective action plan to address any deficiencies found in an independent review.
Also included in the bill is the new Generic Drug User Fee Act, in which the generic drug industry would pay about $1.5 billion over five years in exchange for agreeing to faster reviews of generic drug applications and increased inspections of drug facilities.
The generic fee program is expected to slash review times from 30 months to 10 months, Sen. Tom Harkin (D-Iowa), chairman of the Health, Education, Labor and Pensions Committee, said in a floor speech just before the vote.
“In the last decade alone, from 2001-2010, the use of generic drugs saved the U.S. healthcare system more than $931 billion,” he said.
And the bill also authorizes the new Biosimilars User Fee Act, which applies to products that are shown to be biosimilar to an FDA-licensed biological product. The bill would authorize application, product establishment and biosimilar product-development fees and would set the first three set of fees at a rate equal to the PDUFA rate for each type. The fourth fee—for product development—would be set at 10% of the PDUFA application fee.
The Congressional Budget Office estimated that the bill would reduce the annual federal deficit by a total of $311 million over 10 years primarily because of its provisions accelerating when lower-priced drugs would enter the market.