Political Quotes

“Madam President, I will support final passage of the Food and Drug Administration Safety and Innovation Act which will reauthorize the user fee agreements that govern the fees paid by the pharmaceutical and medical device industries to the Food and Drug Administration, FDA, to expedite the drug and device approval process. These fees are an important funding source that provides the FDA with resources necessary to ensure potentially lifesaving drugs and medical devices can be reviewed and ultimately brought to market quickly and safely. I understand this legislation is the product of a tremendous amount of work by the chairman and ranking member of the HELP Committee, in conjunction with various stakeholders, and enjoys broad support from industry, the FDA, and consumer groups. For the first time, this bill will also create new user fee agreements for generic drug manufacturers; manufacturers of biologics; and would make permanent the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. These two laws together help improve the safety and efficacy of pharmaceuticals for children. Of particular interest, the bill aims to address drug shortages by requiring all manufactures of certain drugs to provide advance notification of possible supply disruptions and any permanent discontinuance of these products to the Health and Human Services Secretary.…”