Ed Markey: “I congratulate everyone. I am pleased that the final bill before us today retains the core drug safety and clinical…”

“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.”