A new survey by the Animal Health Institute found that among its member companies, 29 of 33 new animal drug applications filed in the past two years have taken longer than legally allowed to pass through the FDA animal drug review process.
"This survey shows that review delays for animal drugs at the Food and Drug Administration are a significant and chronic problem," said AHI president and chief executive officer Alexander S. Mathews. "The time for the FDA to act is now. FDA must resolve the review backlog, otherwise veterinarians, pet owners, and livestock and poultry producers will be denied needed medications to treat diseases in animals."
At press time in January, FDA officials were evaluating the survey and would not comment.
The 29 surveyed companies whose applications were overdue said they had waited an average of about three times longer than the required 180 days for their drug approvals to clear. In addition, among surveyed companies, 63 percent of 19 administrative new animal drug applications and 22 percent of 1,037 supplemental new animal drug applications were past due.
The survey, based on AHI member company data for 1998-2000, was released Nov 28, 2000. The AHI represents 80 percent of U.S. producers of animal health care products. |