What is Your Opinion? You Tell the FDA

[Guest guest]

What is Your Opinion? You Tell the FDA

May, 2005

Millions of Americans living with arthritis have been impacted by the

FDA's decisions on COX-2 inhibitors and nonsteroidal anti-inflammatory

(NSAID) medications. The Arthritis Foundation believes that while most

of these decisions have been made to protect the health of Americans

living with arthritis, people with arthritis are not being included in

the government decision-making process nor are their voices being heard

by government decision makers.

Arthritis Foundation President and CEO, Dr. Klippel, has sent an

open letter to FDA Commissioner, Dr. Lester Crawford, urging the FDA to

take several immediate steps on behalf of people with arthritis. These

steps include reconsidering its decisions to remove Bextra from the

market and add warnings of cardiovascular side effects to

over-the-counter NSAIDs; allowing Vioxx to re-enter market if requested

to do so by its manufacturer, Merck; increasing surveillance of drugs

after they are approved to better understand risks; and improving

communication to consumers so they can better understand the benefit

and risks of these therapies. Dr. Klippel met with Dr. Crawford in

January to share these concerns and most recently testified at the

FDA's joint advisory committee meeting of FDA’s Arthritis and Drug

Safety and Risk Management Advisory Committees in February.

The Arthritis Foundation encourages consumers impacted by these

decisions to make their voices heard. The FDA's Center for Drug

Evaluation and Research (CDER) is responsible for the approval of new

drugs and post-market reviews for safety. Send them your comments.

http://www.fda.gov/cder/comment.htm