In the News

House Approves FDA Legislation On User Fees; Senate Vote Upcoming, BNA's Daily Report for Executives

June 21, 2012

Reproduced with permission from Daily Report for Executives, 119 DER A-14 (Jun. 21, 2012). Copyright 2012 by The Bureau of National Affairs, Inc. (800-372-1033) <>

By Bronwyn Mixter

The House June 20 approved by voice vote the Food and Drug Administration user fees bill (S. 3187).

The bill, a product of House-Senate negotiations, reauthorizes the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA). It also creates new user fee programs for generic drugs and biosimilar (or follow-on biologic) drugs.

In addition to the fees, the Food and Drug Administration Safety and Innovation Act includes numerous regulatory provisions affecting drugs and devices, such as incentives for the development of antibiotics, provisions to prevent drug shortages, and a requirement that FDA issue guidance on use of the internet and social media to promote FDA-regulated medical products.

The bill now goes to the Senate for a vote. House lawmakers said they hope the Senate will act early the week of June 25.

Senate and House lawmakers announced they had reached agreement on the bill on June 18 ( 118 DER A-10, 6/20/12). Their negotiations followed the House's approval of its version of the bill (H.R. 5651) May 30, and the Senate's approval of its version May 24.

Unintended Consequences

Steve Mahinka, chair of the Life Sciences and Healthcare Interdisciplinary Group at Morgan, Lewis & Bockius LLP in Washington, said the bill includes a provision designed to foster participation of a patient representative in medical product discussions at FDA.

"This provision could have unintended consequences," Mahinka told BNA. In many cases, the patient community believes the agency is holding drugs to standards that are too high. "This may be beneficial [to industry] because patients will try and move FDA along," he said.

However, Mahinka said patients also are concerned about the cost of products and the patient representative could ask for cost-effectiveness information as part of the clinical trial process to determine whether a product is worth the price.

Additionally, Mahinka said that while there is a confidentiality provision for the patient representative, if the representative does not like FDA's decision, there is the potential for information to be leaked and discussed publicly. Then the issue is whether the threat of publicity will cause FDA to accommodate the patient representative in some way, he said.

"When you add a representative with an entirely difference focus, it is going to affect the process," Mahinka said.

Generic Industry Support

The Generic Pharmaceutical Association (GPhA) applauded the House for approving the bill.

"GPhA fully supports the Food and Drug Administration Safety and Innovation Act and applauds both the House and Senate for the remarkable effort and bipartisan cooperation they have shown throughout this process," Ralph G. Neas, president and chief executive officer of GPhA, said in a statement. "The historic user fee legislation-the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act-will provide FDA with additional resources and ensure all participants in the U.S. generic drug system, whether U.S.-based or foreign, comply with our country's strict quality standards. Very importantly, the programs will make certain that all Americans receive timely access to safe, effective and affordable generic drugs."

Neas urged the Senate to quickly approve the bill "so that consumers, the FDA, and generic manufacturers can begin to see its many benefits."

Device Industry Response

Mark Leahey, president and chief executive officer of the Medical Device Manufacturers Association (MDMA), said in a statement that the bill "represents a strong vision for medical technology innovation over the coming years, and addresses many of the challenges that face our dynamic industry."

"The final language establishes powerful tools and milestones to help ensure that FDA is able to fulfill its dual mission of protecting patients and advancing innovation," Leahey said. "This includes a more reasonable [investigational device exemption] process and strengthening the least burdensome doctrine. FDA's consistent execution and implementation of the key reforms in this legislation and the accompanying Commitment Letter will be critical in making sure that America's patients have timely access to safe and effective products."

Consumer representatives continued to express concerns about the legislation. Public Citizen in a June 19 statement said provisions of the bill would unnecessarily expand the use of the accelerated new drug review process, allow "unlimited numbers" of individuals to serve on FDA advisory panels who have financial conflicts of interest, and constrain FDA's authority to disapprove requests from manufacturers to conduct research studies on experimental medical devices.