|00:00:00||BILL UP AS EXHIBIT NUMBER A THAT IT IS POSSIBLE.|
|00:00:04||AS THE RANKING MEMBER JUST POINTED OUT, THIS IS A BIPARTISAN, BICAMERAL PRECONFERENCE AGREEMENT FOR A VERY COMPLICATED BILL.|
|00:00:13||WE RE-AUTHORIZE THE FOOD AND DRUG ADMINISTRATION USER FEE PROGRAM FOR FIVE YEARS.|
|00:00:17||WE ALSO RE-AUTHORIZED THE MEDICAL DEVICE USER FEE PROGRAM FOR FIVE YEARS.|
|00:00:22||AND I BELIEVE FOR THE FIRST TIME DO ONE FOR GENERIC AND BIOSIMLARS.|
|00:00:30||THIS IS A COMPLICATED, COMPLEX PIECE OF LEGISLATION, BUT IT HAS BEEN WORKED OUT IN A BIPARTISAN AGREEMENT.|
|00:00:49||I HAVE HAD SOME CONCERNS ABOUT THE EXTENT AND THE COST OF THE USER FEES.|
|00:00:52||I WILL CONTINUE TO MONITOR THAT, MR.|
|00:00:53||SPEAKER. BUT THIS IS A GOOD PIECE OF LEGISLATION.|
|00:00:54||THE CHAIRMAN AND RANKING MEMBER AND THE COMMITTEE CHAIRMAN AND RANKING MEMBER AND ALL THE OTHERS WHO HAVE WORKED ON THIS SHOULD BE COMMENDED.|
|00:00:59||THIS IS AN EXCELLENT BILL AND I HOPE THAT THE CONGRESS WILL UNANIMOUSLY SUPPORT IT AND THE SENATE WILL AGREE WHEN WE SEND IT TO THE OTHER BODY.|
|00:01:04||THANK YOU. THE SPEAKER PRO TEMPORE: THE GENTLEMAN FROM CALIFORNIA.|
|00:01:06||MR. WAXMAN: AT THIS TIME I'D LIKE TO YIELD THREE MINUTES TO THE GENTLEMAN FROM NEW JERSEY, MR.|
|00:01:09||PALLONE, THE RANKING MEMBER OF THE HEALTH|
Mr. BARTON of Texas. I thank the distinguished chairman.
Mr. Speaker, I rise in strong support of this bill. When the American public asks, ``Why can't Congress just work together?'' we should hold this bill up as Exhibit A that it is possible.
As the ranking member just pointed out, this is a bipartisan, bicameral preconference agreement for a very complicated bill. We reauthorize the Food and Drug Administration user fee program for 5 years. We also reauthorize the medical device user fee program for 5 years, and, I believe for the first time, do one for generic and biosimilars. This is a complicated, complex piece of legislation, but it has been worked out in a bipartisan agreement.
I have had some concerns about the extent and the cost of the user fees. I will continue to monitor that, Mr. Speaker. But this is a good piece of legislation. The chairman and ranking member and the subcommittee chairman and ranking member and all the others who have worked on this should be commended. This is an excellent bill, and I hope that the Congress will unanimously support it and the Senate will agree when we send it to the other body.