FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007 -- (House of Representatives - September 19, 2007)
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Mr. MARKEY. First of all, I want to commend you, Mr. Chairman, and Chairman Dingell, your staffs, Mr. Waxman, Ranking Member Barton and Mr. Deal, all the Members on the Republican side for the product that is here, all of the staff which has worked on it for so long. My own staff, Kate Bazinsky, who is sitting right here, just was married 2 months ago, this has definitely affected those first 2 months of marriage, the incredible negotiations that have taken place to reach this point, along with Mark Bayer who was working on the privacy parts of this legislation with your staffs. I congratulate everyone.
I am pleased that the final bill before us today retains the core drug safety and clinical trial provisions from the bill that Congressman Waxman and I introduced in March, which will improve transparency at the FDA and make drugs safer. Although I had hoped the sunset would be removed from the pediatric rule and less exclusivity given to blockbuster products under the pediatric incentive program, this bill is a historic achievement which will make drugs and medical devices safer for consumers around the world.
The past several years have been marked by drug scandal after drug scandal, Vioxx, Ketek, Paxil and Avandia. These drugs have harmed families across the country and come to symbolize the urgent need for reform at the FDA. Taking drugs should not be a game of RX roulette, and yet the FDA's current system is broken, and thousands of American families have been harmed by drugs with dangerous side effects.
Today, the House is responding to those failures. The bill is a victory for consumers and for patients. The bill will empower the FDA with important new authorities to mandate label changes and require postmarket studies. However, these new FDA authorities do not change the responsibility of companies to maintain drug labels and warn the public about risk.
For the first time ever, the FDA will have the power to impose civil monetary penalties on companies that fail to conduct required postmarket studies. It will also establish a new postmarket risk identification and analysis system to identify harmful side effects without compromising patient privacy.
Since 2004, I have been fighting for a mandatory clinical trial registry and results database which will ensure that the public has accurate and complete information about drugs and devices.
This bill will create that mandatory clinical trials database.
I am also extremely pleased that the FDA package includes language from the Markey-Rogers pediatric devices bill which is a major step forward for getting better and better devices for kids.
Mr. Speaker, again, I thank the chairman from New Jersey for all his great work.
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