Sherrod Brown: “S. 1082 is a major piece of legislation that aims to--and will--achieve a profoundly important goal. It will improve the…”

“S. 1082 is a major piece of legislation that aims to--and will--achieve a profoundly important goal. It will improve the public health. When it is riskier to take a drug than to skip it, the public health is compromised. When a lifesaving prescription drug or medical device languishes at the FDA because of backlogs in the approval process, the public health is compromised. When pediatricians are forced to fly by the seat of their pants because there is no data to guide the use of a drug or medical device in children specifically, the public health is compromised. When FDA has the responsibility but lacks the tools to assess the safety or effectiveness of a new drug or device, the public health is compromised. S. 1082 tackles each of these problems. It gives FDA more authority and drugmakers a greater incentive to assure the safety of medicines before and after drug approval. It reauthorizes user fees, an additional source of funding that enables FDA to speed up the approval of new prescription drugs and medical devices. It reauthorizes financial incentives to encourage drugmakers to test their products for use in children, and it establishes similar incentives for medical device manufacturers. At the same time, it puts more teeth in FDA's authority to require studies when the health or safety of children is clearly at risk.”