Federal lawmakers have introduced bipartisan, bicameral legislation to reauthorize Food and Drug Administration user fees
for another five years and also authorize a new Generic Drug User Fee Act.
Last month, the House and Senate passed separate versions of FDA bills
that aimed to address drug shortages and medical-device safety issues.
Under the joint bill, the drug industry would pay the FDA more than $700 million in 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 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.
Staff members from the committees worked out the differences in the earlier bills.
“In addition to reauthorizing the user fees that are so important to the FDA's review and approval efforts, the bill also includes several reforms to build certainty and transparency into the process,” Rep. Fred Upton (R-Mich.), chairman of the House Energy and Commerce Committee, said in an announcement about the bill. “Many of these reforms were based on suggestions by patients and innovators who shared first-hand experience of how the current system is broken.”
The announcement about the bill came from Upton, Rep. Henry Waxman (D-Calif.), ranking member on the House Energy and Commerce Committee; and Sens. Tom Harkin (D-Iowa) and Mike Enzi (R-Wyo.), the respective chairman and ranking member of the Senate Health, Education, Labor and Pensions Committee.
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. 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 Premier health alliance released a statement in favor of the bill. “Premier strongly supports the provision that empowers health systems to mitigate the impact of drug shortages by allowing them to repackage shortage drugs into smaller doses and redistribute those drugs to affiliate hospitals within their own system,” the statement said. “Hospitals across the nation struggle daily to secure the drugs needed to treat cancer, fight infectious diseases, provide required nutrition or to treat other serious medical conditions. Providing health systems a mechanism to quickly reallocate drugs across their hospitals to meet their patients' needs is a common sense approach.”