After months of negotiations and congressional hearings, the House and Senate have passed The Food and Drug Administration Safety and Innovation Act. The legislation, which Congressman Michael C. Burgess (TX-26) was influential in crafting major provisions, will address important issues to enhance the work of the Food and Drug Administration (FDA) while correcting missteps of the agency in areas such as public input, good guidance practices, and the manufacture of custom devices.
"The process to this vote from the very beginning was respectful and resulted from hundreds of hours of negotiations," said Dr. Burgess. "By working together we were able to address key areas of concern allowing the industry to continue to partner in providing physicians and health care providers the tools they need to prevent and alleviate human suffering. It will also ensure that the FDA has the scientific and medical expertise they need when reviewing products utilizing emerging science or those for rare disease populations. This is about patients and they will be better served by the passage of this bill."
The final version of the legislation that passed the Senate retains significant reforms made in the House bill and enhances other provisions, such as drug shortages. In addition, the legislation will ensure that the FDA has the scientific and medical expertise they need when reviewing products utilizing emerging science or those for rare disease populations.
"It is important that we spur innovation for antibiotic, rare disease, and pediatric oncology drug development and enhance other provisions such as drug shortages," said Dr. Burgess. "I still believe that we should strengthen and improve the oversight of laboratory-developed tests instead of even contemplating duplicative regulation."
President Obama is expected to sign the legislation into law before Thursday morning.