Statement of The ALS Association: The Prescription Drug User Fee Act.

WASHINGTON -- The ALS Association today issued the following statement from Steve Gibson, vice president of government relations and public affairs, on the Food and Drug Administration's recommendations to reauthorize the Prescription Drug User Fee Act (PDUFA).

"The ALS Association welcomes the FDA's recommendations for reauthorizing the Prescription Drug User Fee Act. The agency has proposed important new initiatives and recommended increased funding levels in key areas that will benefit people with ALS (Lou Gehrig's disease) and help ensure that they have timely access to safe and effective medicines.

"While the recommendations call for additional resources to support FDA's drug safety programs, The ALS Association is particularly pleased that FDA also has proposed increased funding and new initiatives that will enhance the drug approval process and encourage new approaches to drug development.

"The proposal provides increased support for the Critical Path Initiative, an important program designed to streamline drug development. It facilitates partnerships between FDA, the public and industry that will promote new ideas to advance medical science. And it recognizes that the practice of medicine is not a one-size-fits-all proposition by examining new ways to assess the benefits and risks of medications that can save lives. Many of these initiatives were not included in prior versions of PDUFA, and we hope they will help provide new opportunities to bring ALS therapies from the lab to the bedside.

"As the debate on PDUFA reauthorization begins, it is important that Congress take action early this year to ensure the FDA has the resources to fulfill its mission and ensure patients have access to state-of-the-art, life-saving treatments. People with ALS have no time to wait.

"The ALS Association looks forward to working with Congress and the FDA to reauthorize PDUFA this year and improve patient safety by providing timely access to effective treatments."

The ALS Association is the only national not-for-profit health agency dedicated solely to the fight against Amyotrophic Lateral Sclerosis (ALS), more commonly known as Lou Gehrig's disease. ALSA covers all the bases--research, patient and community services, public education, and advocacy--in providing help and hope to those facing the disease. The mission of The ALS Association is to find a cure for and improve living with amyotrophic lateral sclerosis.