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Pallone Statement on FDA User Fee Agreements

April 18, 2012
Press Release

Washington DC – Congressman Frank Pallone, Jr. (NJ-06), Senior Democrat on the Energy & Commerce Subcommittee on Health, today delivered the following statement at a hearing to help bring breakthrough medications to the market faster:

"Thank you Chairman Pitts.  Today the Subcommittee is meeting to hear testimony about the released discussion draft concerning the Prescription Drug, Medical Device, Generic Drug and Biosimilar Drug User Fee Agreements, as well as several other FDA-related proposals including programs to foster the develop of prescription drugs for children, administrative and regulatory reforms at the FDA and drug shortages. 

"I will note, as a matter of process, each of these issues has had its own hearing in the Subcommittee over the course of the three months.  I want to commend Chairmen Pitts and Upton and the staffs on both sides.  We have worked very hard to cover a lot of ground.  I’d also like to thank all the Subcommittee members for their participation in these hearings, and I welcome their comments and suggestions on the discussion draft as we continue to move forward. 

"Let me state at the onset that we have not yet reached full agreement on the discussion draft in time for today’s hearing.  As will be seen, the bill contains language largely identical to the March draft released by the Republicans, except for the brackets surrounding a majority of the text.  These brackets indicate that the bill is a work in progress and we continue to make headway.

"There are many issues that have been worked out.  Specifically, we have been able to make substantive changes to the FDA reforms that, as drafted, would have led to many unintended and unacceptable consequences to FDA’s regulatory scheme.  We have also been working hard to include language that would equip the FDA with the authority and the resources it needs to address a growing global drug supply.  That language has come a long way and I am optimistic that we can strengthen it further.

"Now, it’s important to note, there are still key concerns that remain.  But the process has been a good one to date and I am hopeful that we can come together to address those outstanding issues and generate a consensus, bipartisan product both sides can support. 

"Let me quickly comment on the four user fee proposals that are the impetus behind this legislation.  The discussion draft is largely based on the agreements between the FDA and the industry.  These programs represent a critical opportunity to work alongside FDA, industry and other stakeholders, to build upon and improve these critical programs.  Together we can help give patients’ access to safe, effective and breakthrough medical treatments while supporting the advancements of science and promoting a thriving life sciences industry in the United States

"Of particular note, of course, is the new Generic Drug User Fee Agreement which will dramatically improve the median approval times for generic applications.  This program will bring an influx of generic drug products onto the market and into the hands of consumers, thereby significantly lowering health care costs.  

"I would like to welcome back all of our witnesses here today, you have been great resources to our Subcommittee throughout this process.  So, we are eager to hear your opinions and whatever suggestions you may have for us as we move forward.  I look forward to working with you Chairman Pitts leading up to next week’s scheduled markup to improve the discussion draft further.  I thank you for your continued bipartisanship.

"I’d like to yield the remainder of my time to Mr. Dingell."


Ray Zaccaro