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Public Statements

Food and Drug Administration Reform Act

Floor Speech

By:
Date:
Location: Washington, DC

Ms. RICHARDSON. Mr. Speaker, I rise in support of H.R. 5651, The Bipartisan Food and Drug Administration Act of 2012, which modifies the Food and Drug Administration's (FDA) policies and procedures to enhance Americans' access to effective healthcare. This bill improves the safety, development, and distribution of medications and medical devices to patients and medical providers.

This bill reauthorizes the FDA's user fee program for prescription drugs and medical devices through fiscal year 2017. Further, it introduces a new user fee program for generic medications. These fees, collected from drug and medical device companies, will give the FDA the funding it requires to grant patients rapid access to the treatments they need. This will improve the accessibility of vital medicines to patients throughout the U.S.
Mr. Speaker, this bill permanently reauthorizes two beneficial pediatric drug programs. The first, the Best Pharmaceuticals for Children Act, enhances the safety and availability of prescription drugs for children. It does this by providing mechanisms through which drug companies can test their products for use in pediatrics, and offering a six month patent extension as an incentive to companies who do so.

The second pediatric drug program that is permanently reauthorized is the Pediatric Research Equity Act. This act increases the safety of prescription drugs for children by requiring pediatric testing of certain medications intended for adults in order to fully understand their effects. This will ensure that physicians have a clearer grasp of the effects these medications have before prescribing small dosages to children.

This bill also provides for a vital update of the FDA's global drug supply chain authority, requiring drug importers to register with the FDA, and disallowing the import of medicines from organizations that have limited or denied inspections.
Most importantly, the bill expands the jurisdiction of the Federal Food, Drug, and Cosmetic Act. This allows for the FDA to prosecute foreign violators of the act, and thus discourages such violations in the future. These updates will improve the safety of the prescription drugs that are provided to American patients.
Finally, Mr. Speaker, this bill will implement new FDA requirements that will help to prevent drug shortages. The bill does this by updating the FDA's reporting policies for manufacturers, and ensuring that the agency maintains a drug shortage list that is made available to healthcare providers. Additionally, should a shortage still occur, this bill outlines steps to be taken to mitigate the problem. If enacted, these new policies will help protect the country's prescription drug supply, ensuring that Americans always have access to the medication they need.

Mr. Speaker, it is for these reasons that I support H.R. 5651.


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