Political Quotes

“I applaud the effort underway between the FDA and industry to develop a transitional pathway for the regulation of emerging diagnostic tests. In addition, I am pleased that the FDA expressed its commitment to work with industry on this important initiative in the MDUFA III commitment letter. Many new diagnostic tests serve as the missing link to improved health care through better detection, treatment, and monitoring of disease. Thus, it is critical for public health that FDA's premarket review system for diagnostics be modernized in a manner that supports advances in the sciences and promotes patient access. I look forward to developments with respect to the agency's plans to develop a transitional in vitro diagnostics pathway and steps taken related to its implementation. I also wish to talk about two massively important laws that work to ensure that medications used in children are tested and labeled correctly--the Best Pharmaceuticals for Children Act, known as BPCA, and the Pediatric Research Equity Act, known as PREA. Taken together, these two laws encourage and require drug companies to study their products in children. They have been hugely successful in ensuring that physicians and parents have information needed to best treat our Nation's children. Most drugs on the market have never been tested in children, largely because manufacturers face economic, mechanical, ethical, and legal obstacles that work to discourage pediatric testing.…”