Safe Cosmetics Alliance | August 1, 2012

President Barack Obama signed the bipartisan Food and Drug Administration Safety and Innovation Act into law earlier this month after it sailed through both chambers of Congress.

The final vote in the Senate was 96 to 1.

The bill (S.3187) reauthorized the Prescription Drug User Fee Act (PDUFA), according to a statement from the White House. It was the fifth time the act was reauthorized since its inception in 1992.

PDUFA increases the FDA’s ability to provide timely and expedited review and approval of applications for prescription drugs and medical devices, extends and modifies FDA authorities related to drugs intended for use by children, and improves the drug approval process and helps to reduce drug shortages.

The Safe Cosmetics Alliance is seeking the same bipartisan support for H.R. 4395, the Cosmetic Safety Amendments Act of 2012, which would establish the FDA as the primary regulatory authority on cosmetic safety and give them the tools to improve and strengthen oversight of personal care products. The passing of PDUFA with overwhelming bipartisan support shows Congress can come together to help drive innovation forward.

Leaders in both parties praised the efficiency and cooperation across the aisle that allowed the bill to pass so easily.

Republican Sen. Mike Enzi of Wyoming, who co-sponsored the bill with Sen. Tom Harkin of Iowa, said:

“This bill’s passage is a victory for the millions of Americans who need medicines or medical devices, and for the kind of bipartisan cooperation that we see all too rarely in Washington.”

Harkin also emphasized the bipartisan support for the bill: “Approval of the Food and Drug Administration Safety and Innovation Act is the result of nearly two years of bipartisan cooperation and hard work. This bill is a great example of the kind of progress we can achieve when we work together, and we are grateful to all of our colleagues for their efforts in this process.”

The House also passed the bill with strong bipartisan support. PDUFA passed the House 387 to 5, and was sponsored by House Energy and Commerce Committee Chairman Rep. Fred Upton (R-MI) and co-sponsored by Rep. Joe Barton (R, TX), Rep. John Dingell (D, MI), Rep. Frank Pallone (D, NJ), Rep. Joe Pitts (R, PA), and Rep. Henry Waxman (D, CA).

For more information on the Safe Cosmetics Alliance please visit