Advertisement

Penicillin in peril

July 10, 2008|By David Wallinga and Margaret Mellon

Over the past five years, the FDA has consistently neglected taking the difficult steps to address the problem of antibiotic resistance for the long-term benefit of human health. Unless the Animal Drug User Fee Act is revised to include and fund safety goals for what happens after new animal drugs get marketed, our public health will continue to get short shrift.

The new bill must make public health a priority by addressing the way overuse of antibiotics in animals has eroded the efficacy of those drugs. Congress should establish a process to impose firm new timelines on the FDA to review antibiotics approved long ago. Such a process could cost as little as $1 million to implement, well within the FDA's annual budget for review of antibiotic resistance associated with animal agriculture.

These public health provisions are not radical. When the Prescription Drug User Fee Act for human drugs was reauthorized last year, it included increased fees to provide for post-market human drug safety.

Advertisement

Congress must act now to add provisions to the Animal Drug User Fee Act to achieve a prompt review of antibiotics approved well before concerns rose about resistance. If it fails to do so, it risks passing a bill that compromises America's public health.

Dr. David Wallinga, director of the Food and Health Program at the Institute for Agriculture and Trade Policy, and Margaret Mellon, director and senior scientist at the Union of Concerned Scientists, are members of the Keep Antibiotics Working Coalition.

Baltimore Sun Articles
|