Life Science Compliance Update

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July 18, 2017

United States House of Representatives Passes PDUFA


On Wednesday, July 12, 2017, the United States House of Representatives passed a bill via voice vote to reauthorize the prescription drug, generic drug, medical device and biosimilar user fee programs through 2022.

The current user fee programs expire September 30th, though the United States Food and Drug Administration (FDA) has said that if the reauthorization bill is not signed by President Donald Trump before August 1st, the FDA will be forced to send out layoff notices to about 5,000 employees.

“This legislation will save lives,” Representative Greg Walden said on the House floor, noting he thinks the Senate will adopt the bill, as well.

In addition to reauthorizing the user fee programs, the bill contains several new directives for the FDA, including provisions requiring quicker reviews of some generic drugs and changes in how the agency will conduct medical device inspections. The FDA will also be instructed to work on expanding clinical trial criteria so more patients can be eligible for experimental medicines. The bill is expected to cut the time it takes the agency to approve new treatments.

The House added more than a dozen new sections to the bill ahead of the vote, including sections aimed at curbing abuse of the orphan drug designation and policies designed to speed generic drug approvals. Most of the new elements of the House bill were added to align the chamber's legislation with the version passed out of the Senate HELP Committee. The House bill added a new title focused on pediatric drugs and devices that would allow the FDA to require adult cancer drugs that share a common target with a pediatric cancer to be studied in children starting in 2020. Other new elements of the bill clarify when pediatric information can be left off a drug's label to speed access to generic medicines, and new sections mandating that FDA review generic drug applications within eight months if the brand drug patents have expired and the treatment has three or fewer approved competitors on the market.

Several sections of the bill were removed ahead of the vote, including provisions altering the notification requirements for FDA related to laboratory developed tests, requiring FDA to issue guidance on how to demonstrate bioequivalence to a reference drug to facilitate generic development, a section on information technology contracting, and legislation designed by industry and the FDA to create an over-the-counter monograph.

Senate Reaction

The Senate has yet to schedule a floor debate and vote on its version of the user fee bill. Senate Lamar Alexander said Wednesday that it's now time for the full Senate to consider these bipartisan user fee agreements.

Senate Majority Leader Mitch McConnell (R-KY) has stated, “It’s an extremely important bill that I think we’ll be able to move on a bipartisan basis.” And ranking member Patty Murray (D-WA) pledged a “bipartisan and non-controversial” user fee bill, highlighting the necessity of similar legislation.

However, Senator Ron Johnson also said Wednesday that he will try to delay the bill unless it includes language related to the “Right-to-Try” legislation, which undercuts FDA and has been sweeping across states. A nonpartisan report issued Tuesday notes that issues with expanded access are not linked to FDA regulations.

The Congressional Budget Office says it expects the FDA to collect roughly $9 billion in fees—$8 billion for drugs and $1 billion for devices—between 2018 and 2022, based on the fee level set in the Senate bill.

Industry Reaction

FDA Commissioner Scott Gottlieb, MD, praised the passage of the bill in the House on Twitter:


Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen J. Ubl issued the following statement,

Timely reauthorization of the Prescription Drug, Biosimilar and Generic Drug User Fee Acts is crucial to patients in need of life-saving treatments and enhancing the competitive market in biopharmaceutical innovation. The House took an important step in reauthorizing the user fee programs and we look forward to swift action in the Senate on behalf of America’s patients.

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