Senator Dan Coats (R-Ind.) today made the following statement after voting for the Food and Drug Administration (FDA) Safety and Innovation Act, legislation that includes user fee agreements negotiated by the FDA with the drug and medical device industries and proposals to streamline FDA's review and approval of medical products.
"This bill increases patient access to new medical technology, protects American jobs and improves the FDA so America will remain a global leader in biomedical innovation," Coats said. "Indiana is home to numerous companies in the medical device and pharmaceutical industries, and this bill will help these Hoosier employers grow and expand their operations."
In addition to the user fee agreements, the legislation also includes reporting requirements to help address the current drug shortage problem.
"I am pleased this bill will help address the growing problem of drug shortages across the country," added Coats. "This critical problem reduces the quality of care to patients and forces health care providers to use alternative and more costly drugs. I hope this bill will help mitigate the dangerous drug shortage problem hospitals face."
The legislation passed the Senate today 96 to 1.