Sen. Richard Burr (R-N.C.) criticized what he described in a Senate floor speech as a rush for Congress to finish the bill before the Supreme Court's ruling on the 2010 healthcare overhaul and the partisan sniping it is expected to unleash.
Burr said he was frustrated that the bill did not include bipartisan "track and trace" provisions or an accountability matrix for the FDA.
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—in particular, 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-'17 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 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 Congressional Budget Office estimated that the bill would reduce the annual federal deficit by $311 million over 10 years primarily because of its provisions to accelerate lower-priced drugs' entry into the market.
An industry group said the legislation's measurable performance goals and additional funding should help reverse a decline in FDA performance in recent years.
"This legislation will help improve an already robust review process by giving FDA the additional tools and resources it needs to improve its timeliness and consistency," Stephen Ubl, president and CEO of AdvaMed, said in a written statement issued after the vote.