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Pallone Statement At Health Subcommittee Markup Of PDUFA, MDUFMA, Drug Safety & Pediastric Legislation


Location: Washington, DC


U.S. Rep. Frank Pallone, Jr. (D-NJ), Chairman of the House Energy and Commerce Subcommittee on Health, gave the following opening statement this morning at a subcommittee markup of legislation reauthorizing the Prescription Drug User Fee Act (PDUFA), the Medical Device User Fee and Modernization Act (MDUFMA), the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA).

"Good morning. Today we are marking up legislation that will reauthorize the Prescription Drug User Fee Act (PDUFA), the Medical Device User Fee and Modernization Act (MDUFMA), the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA). In addition, we are taking up legislation to improve the development of pediatric devices. Finally, we are moving forward with legislation that would significantly improve our nation's drug safety system.

"Let me begin by commenting on the process in which these bills have moved through the Subcommittee. First, I want to reiterate that each of the bills being marked up today deal with an issue that we have held a hearing on over the past six weeks. In addition, we circulated our discussion drafts well in advance of the originally scheduled Subcommittee markup, so Members and stakeholders would have time to analyze our proposals and make comments.

"However, during our hearing last week, the minority voiced significant concerns that we were proceeding too quickly and that there was not sufficient time for the two parties to reach an agreement on the proposals. As Chairman Dingell indicated in his opening statement, we wanted to make sure that the minority was treated with respect and that the process for marking up these bills was fair.

"Accordingly, Chairman Dingell, Ranking Member Barton, Mr. Deal and I agreed to postpone last week's scheduled Subcommittee markup in order to afford our staff more time to reach agreement on some of the issues before us today. This was a good decision. While our staffs were not able to reach agreement on every issue, they made remarkable progress at resolving many of the concerns held by Members from both parties.

"At this point I do want to take a moment to thank both the majority and minority staff for all their hard work. I think that everyone should know that they worked literally day and night over the past week to get us to the point where we are today. They have performed a great service for this Committee and they should be commended for their efforts. Thank you to all of the staff for the work that you have done on these bills.

"I would be remiss if I also didn't thank the members who have played a crucial role in the development of these proposals. I would like to thank Mr. Markey and Mr. Rogers for their efforts to facilitate research and development of pediatric devices. Presently, there are too few medical devices designed to be used in children. Instead, doctors are often forced to jury-rig devices that are designed to treat adults. This legislation will help ensure that America's children have access to medical devices that are specifically designed fit their small and growing bodies.

"I would also like to thank Ms. Eshoo for the work she has done to reauthorize BPCA and PREA. These two programs have resulted in important labeling changes that have helped ensure that our children have access to the safest and most effective medications. Thanks to Ms. Eshoo's efforts, these two programs will continue to be a great success.

"Finally, I applaud Mr. Waxman and Mr. Markey who have been leaders in the development of the drug safety provisions that we will mark up today. Thanks to their work, this Subcommittee is taking one step closer to ensuring that the FDA has the regulatory authority it needs to protect American consumers from potentially harmful drugs.

"Over the past few years, it has become apparent that patients are being placed in harms way due to the failings of our current drug safety system. As a result, the American people have steadily begun to lose faith in the FDA. That must change. FDA is a critical government agency that is full of incredibly talented and hard working people. But those people have been hamstrung by a lack of resources, failing leadership, and weak regulatory power to protect the American public.

"We must restore public confidence in the FDA's ability to protect people from harmful products and safeguard the public health. But first the FDA must change. The legislation before us will undoubtedly help in that regard. There are many other members to thank, both on this Subcommittee and the Full Committee, who have been integral to this process.

"Again, we tried to reach agreement on as much as we could. While we may not see eye to eye on every provision in the proposals before us today, I am confident that the actions we take here today will have a profoundly positive impact on the millions of Americans who rely upon prescription drugs and medical devices to live healthy and productive lives.

"I also think every member of this Committee should be proud about the process in which we are moving forward. I now recognize my good friend from Georgia, Mr. Deal, for five minutes for the purpose of making an opening statement."

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