Kevin Roberts: “I rise today to speak on the legislation that is actually before us as opposed to the topic before, the Food and Drug…”

“I rise today to speak on the legislation that is actually before us as opposed to the topic before, the Food and Drug Administration Safety and Innovation Act that we are currently debating. In addition to reauthorizing the user-fee agreements, this legislation includes many other important provisions. Members should know what is in this bill and how important these provisions are. There is language to permanently reauthorize pediatric research incentives, programs to incentivize antibiotic research and development, and more transparency and accountability for the FDA and stakeholders, which we hope will help to address drug shortages. That is a big problem not only in urban areas but in the rural health care delivery system in every State. Every Senator ought to be aware of that, and I am sure they are hearing about it. In May I joined with Senators Reed, Murray, and Alexander in introducing the Better Pharmaceuticals and Devices for Children Act, the BPDCA. I don't think that makes a very good acronym, so I am not even going to try it. Back in 1997 Congress passed the Best Pharmaceuticals for Children Act, which acknowledged the importance of ensuring medications were effective and safe for children by providing an incentive for pharmaceutical companies to invest in pediatric research. In 2003, with the passage of the Pediatric Research Equity Act, Congress required the pharmaceutical companies to engage in these studies.…”