FDA hopes better guidelines for medical companies will speed new treatments

Thursday, January 30th 2003, 12:00 am

By: News On 6

WASHINGTON (AP) _ Worried about a serious slowdown in the creation of novel drugs, the government is taking steps it hopes will speed medical innovation, largely by making clearer how companies can prove a new product works before they waste time researching the wrong thing.

Atop the Food and Drug Administration's priority list being announced Friday are guidelines to speed treatments for cancer, obesity and diabetes _ three of the country's leading ailments.

The main issue is not how quickly FDA scientists review treatments _ that has sped up greatly in recent years _ but the time it takes to research and develop new medications and medical devices, FDA Commissioner Mark McClellan said.

That work can take over a decade and cost hundreds of millions of dollars. McClellan's hope is that by making FDA's requirements for approval more clear from the start, that research could be performed better and faster _ and companies might not be as reluctant to take a chance on novel treatments instead of financially safer copycats.

McClellan said that does not mean the agency is relaxing its requirements.

``If the drugs don't meet the standards for approval, they're not going to get through,'' McClellan told reporters Thursday. ``But it's in everybody's interest to figure out more quickly and at a lower cost.''

Drug companies are sending the government fewer groundbreaking medications each year. The FDA approved just 17 never-before-seen chemicals last year, down from 24 in 2001, said drug chief Dr. Janet Woodcock. The agency received 23 applications for those novel drugs last year, down from 30 the year before and a high of 60 in 1995.

Similarly, the FDA approved 32 novel medical devices last year, down from 56 in 2001.

McClellan's plans are more a repackaging than a completely new approach. For years, the FDA has encouraged companies to seek its advice early in a product's development.

But too few do, said veteran FDA watcher Ira Loss of Washington Analysis. He cited ImClone, a biotechnology company that imploded after the FDA rejected its potential cancer treatment Erbitux in December 2001, citing shoddy science that failed to tell if the drug had any effect. The company's top executive later was charged in an insider-trading scandal.

``At some point, you have to hold the industries accountable for not taking advantage of the opportunities presented to them,'' Loss said.

Drug discovery is cyclical and dependent on far more _ scientific serendipity and financial investments, for example _ than the FDA, Loss noted. But McClellan's plan ``can't hurt. If it will help (with speed), we'll have to wait and see.''

Among the FDA's plans:

_Help companies understand what is needed for quality applications so that more approvable treatments get the FDA's OK on the first try. The FDA rejects half of all novel medications and 93 percent of cost-saving generic drugs on the first try.

Too often the FDA discovers companies had data that would have cleared up concerns yet did not think to provide it at first, said medical device chief Dr. David Feigal. That can delay marketing at least six months.

_Developing special guidelines for brand-new technology, such as gene therapy, bioengineered tissue or drug-and-device combinations so companies can design the right studies from the beginning.

_More training of FDA reviewers and consistency in requirements for each application.

The medical device industry welcomed the news.

``The more innovators can know what the requirements are at the beginning of the process, the more quickly we can get those kinds of breakthroughs to patients,'' said Randy Burkholder of the Advanced Medical Technology Association.

The drug industry's Pharmaceutical Research and Manufacturers of America declined comment, but noted that over 1,000 experimental medications are in development, and almost 4,000 studies of those potential drugs are under way in patients.