 |
|
|
|
|
Drug Approval Process Improving
FDA finds 2003 better than 2002, and adds things are moving faster
By Amanda Gardner
HealthDay Reporter
|
| | | | Related Healthscout Videos | |
|
MONDAY, Jan. 19 (HealthDayNews) -- The U.S. Food and Drug Administration claims there were "improved results" in approvals for new drugs and biologic agents in 2003.
Last year, the agency approved 466 new and generic drugs and biological products. FDA officials did not give an equivalent figure for 2002 because jurisdictions had been changed, making it difficult to track a total number for that year.
Text Continues Below
The agency says it was particularly pleased with the fact that 21 of the approvals in 2003 were New Molecular Entities (NMEs), which contain active ingredients new to the U.S. market and which can serve as a barometer of industry innovation. In 2002, 17 NMEs were approved. As for new drug applications (NDAs), 72 were approved in 2003, compared to 78 in 2002.
"We did see an increase in the number of new molecular entities, which has been something that's been a large concern, not only from the public health perspective but also from an industry perspective. Is the innovation slowing down?" says Dr. John Jenkins, director of the FDA's Office of New Drugs and Center for Drug Evaluation Research. "While we don't know yet if it is a trend, it is encouraging."
The FDA also touted shortened approval times for many categories of approvals as well as more approvals for priority products. In 2003, 14 NDAs that were given priority status were approved, compared to 11 in 2002, while nine NMEs that were given priority status were approved in 2003, compared to seven in 2002.
All of this is apparently being done without a decrease in safety. "We don't think there's been any compromise to safety, as we've been able to streamline our process," Jenkins says. He points out that no drugs have been recalled for safety reasons for over a year.
One thing the federal agency did not mention, however, was how the year of comparison, 2002, stood in relation to other years, especially regarding NMEs. "They're using as their standard of comparison the worst year in the last decade" for the number of NME approvals, says W. Patrick McGrath, executive director of the Office of Industrial Liaison at the Mount Sinai School of Medicine in New York City.
Page: 1 | 2 | Next >>
|
Copyright © 2004 ScoutNews, LLC. All rights reserved.
Last updated 1/19/2004
|
|
SOURCES: John Jenkins, M.D., director, Office of New Drugs and Center for Drug Evaluation Research, U.S. Food and Drug Administration, Rockville, Md.; A. Mark Fendrick, M.D., professor, internal medicine, University of Michigan School of Medicine, professor, health management and policy, University of Michigan School of Public Health, Ann Arbor, and editor-in-chief, American Journal of Managed Care; W. Patrick McGrath, Ph.D., executive director, Office of Industrial Liaison, Mount Sinai School of Medicine, New York City
|
.gif)
