"While the current version of the discussion draft contains several provisions that I have authored, I am disappointed that it is missing an opportunity to vastly improve the safety of medical devices and protect patients from serious harm. The FDA has made clear that it does not have the legal authority to reject a new medical device outright as long the device proves it is similar to the earlier model, even if the earlier product was recalled for harming patients. I look forward to working with my colleagues to include language in this legislative package to ensure that the FDA has the ability to act on information that a new device could be seriously harmful to patients without having to wait until the device is implanted in patients and people have suffered irreparable harm."
The reauthorization of BPCA and PREA makes significant improvements to the laws to increase the number of studied medications available for children that would help reduce incidences of wrong dosage or age and size-appropriate treatment.
"I am pleased to see that the discussion draft includes much of what was negotiated on a bipartisan basis for the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. I am proud to work with my colleagues Reps. Mike Rogers and Anna Eshoo on these important bills that expand the number of drugs and therapies available for children. Because of these laws, in the past five years alone at least 130 medications have been studied for use in children, providing doctors and patients with vital information about the appropriate use, dosage, and side effects of pediatric drugs."