FDA drug approval times slightly faster, but still no booming 1990s

Monday, January 28th 2002, 12:00 am
By: News On 6

WASHINGTON (AP) _ Medicines aren't racing onto the U.S. market nearly as fast as they did in the booming late 1990s, but federal regulators did slightly speed up their reviews of therapies last year.

Government figures released Friday come amid growing complaints by manufacturers that President Bush needs to appoint a new commissioner for the Food and Drug Administration, leaderless for a year, to speed new therapies.

That's an excuse, veteran FDA watchers say: the agency's commissioner has no real role in how quickly treatments are reviewed.

But the latest statistics promise to play a role in upcoming congressional negotiations over how much money the FDA needs to do its job.

Last year, the FDA approved 66 new drugs, 24 of which contained never-before-sold ingredients.

Ten were ``priority'' drugs, or potential breakthroughs _ and they still speeding through the FDA. The median approval time was six months, unchanged from previous years. One, a major advance in leukemia therapy called Gleevec, set a record this spring when it won FDA approval in less than three months.

Median approval time for the other, so-called ``standard'' drugs was 14 months. That's not as fast as the 11.6 months such drugs spent at FDA in 1999 but a little faster than the 15.6 months FDA spent such products in 2000, FDA records show.

One reason the FDA isn't as fast as in the 1990s: About a dozen drugs have been pulled off the market since 1997 because of dangers, noted Ira Loss, a drug analyst with Washington Analysis.

``What we're seeing here is FDA is being cautious,'' he said.

But it's partly industry's fault, too, he said. ``In some cases I think companies have come in with data that was less than dramatic.''

Biotechnology products proved more complicated. The FDA's median review time of these products was 13.8 months _ but it took 20.3 months for them to go on to win final approval.

That's a little faster, by five months, than in 2000, said biotech review chief Robert Yetter.

Why the big holdup between reviewing data and letting sales begin? FDA says one reason is that once it terms a biotech product safe and effective, the manufacturer still must prove it can make enough doses properly, factory issues that can take months to resolve.

Indeed, numerous companies, including such vaccine giants as Wyeth-Ayerst, have had serious manufacturing problems recently, Loss noted.

As for an FDA commissioner, drug manufacturers have lobbied hard to block the latest top contender under consideration by the White House, Vanderbilt University pharmacologist Alastair Wood, who is an expert on medication safety. Democratic senators insist, however, that they in turn would block any candidates who work in the drug industry.