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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.

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.

Still, numbers aren't everything and many experts, including McGrath, do see hopeful signs.

"Apparently, the FDA's communication of what they would like in a new drug application is being listened to by industry and leading to a more efficient application review process, which hopefully translates into benefits for both the FDA and the company," says Dr. A. Mark Fendrick, a professor of internal medicine at the University of Michigan School of Medicine and a professor of health management and policy at the University of Michigan School of Public Health.

In particular, Fendrick says, pre-application meetings between FDA officials and those in the drug industry seem to be contributing to a stepped-up efficiency, as they result in applications which, as Jenkins puts it, "are in better condition for approval."

"My view is that, as companies get more comfortable dealing with pre-application programs, we're going to continue to see increases in efficiency on both the industry and the agency side," Fendrick says.

It also helps that the FDA has a commissioner, Dr. Mark McClellan, after having gone about two years without one, and that he has made drug development a priority, Jenkins adds.

"Bringing in a player like McClellan has certainly energized the agency," Fendrick says. "It appears under the McClellan administration that the FDA is taking this approval time issue very seriously."

The FDA has stated it wants to eventually reduce review time by 10.5 percent by reducing multiple cycle reviews (that's when the FDA tells a company it needs to change something and the process starts over from scratch) and initiating even earlier communication with manufacturers.

The actual number may be less important than the process behind it, McGrath says. "They talked about 'focused communication with product developers about FDA standards.' That sounds vague, but it's something that can make a big difference," he says. "They're saying that we realize we should meet with them right away and, if they really do, that's an important thing... A more important objective is that the review time will drop. And if that happens, then more deserving drugs will be approved and drugs that are not deserving will not be approved."

More information

The FDA has more on new drug development and on last year's new molecular entities.

(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)

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