Recent Press Releases

Washington, D.C. —  Today the United States Senate overwhelmingly passed legislation (93-1) that would improve the process used by the Food and Drug Administration (FDA) to approve prescription drugs. The FDA Authorization bill (S. 1082) includes an amendment introduced last week by Senators John Thune, Debbie Stabenow (D-MI), Trent Lott (R-MS) and Sherrod Brown (D-OH), that would reduce the filing of frivolous petitions, which delay entry of generic drugs to the market, and unnecessarily increase drug costs for both taxpayers and consumers.

The Stabenow-Thune-Brown-Lott amendment would prohibit delays of generic drug approvals unless the FDA determines within the first 25 days of the filing of a "citizen" petition that it raises a genuine, public health concern. The amendment also allows the FDA to verify that citizen petitions are in fact legitimate. These important changes will help remove the incentive for drug companies to file unfounded or illegitimate citizen petitions which only serve to delay the approval process.

"Under current FDA regulations, the simple act of filing a petition, regardless of how meritorious or frivolous that petition may be, automatically delays the approval of a generic drug. This simple act postpones the delivery of cheaper generic drugs to the market place. Our amendment protects the rights of individuals to file a petition while reducing delays and abuses in the generic drug approval process.

"The rising cost of prescription drugs is one of the largest drivers of health care costs in our country today, which contributes directly to the rising cost of health insurance premiums for families, small businesses and the federal government. I will continue to work to reduce the cost of health care in this country while improving access to care for all South Dakotans," said Thune.