FDA Made Landmark Move in 2002

The FDA made a landmark move in 2002 -- re-approving Lotronex, a drug for irritable bowel syndrome, which had been pulled from the market. That left many wondering about the safety of many drugs that are currently available. But the FDA didn't stop there. It was another busy year -- with new drugs for everything from ADHD to the first non-sedating antihistamine to be sold over the counter.

Some from the pharmaceutical industry still view the agency as too slow in considering applications, while consumer groups worry that the FDA is sacrificing safety in a rush to approve new drugs.

That controversy was highlighted this year in the re-introduction of Lotronex, a drug for women with diarrhea-prominent irritable bowel syndrome that was removed from the market in November 2000 as a result of several patient deaths. A campaign by patient advocates helped convince the FDA to reapprove the drug -- albeit with unprecedented restrictions.

The decision "reminded the world of the importance of considering benefit when you think about risk," Steve Weisman, PhD, head of the healthcare product consulting practice at Innovative Science Solutions, tells WebMD. "There's no other accepted treatment [of the severe form of the disease], and these patients are really miserable."

But the approval has some consumer groups hopping mad. "It is definitely a lowering of standards," Larry D. Safich, PharmD, MPH, pharmacist and researcher at Public Citizen's health research group, tells WebMD.

The questions don't apply only to Lotronex. The FDA also approved Zelnorm this year, for a different form of irritable bowel syndrome, despite concerns that it may cause gall bladder problems in some patients. Another drug for non-Hodgkin's lymphoma is under consideration despite unusually serious side effects, David L. Webster, PhD, president of the Webster Consulting Group, tells WebMD.

"It's a huge dynamic in that there are outcries that the agency approves drugs too quickly, and of course there is an outcry from industry that it's too slow," says Weisman.

Still, one study found that a new drug has a one-in-five chance of causing death or serious injury as a result of unanticipated side effects. "The FDA needs to study these drugs more extensively in the pre-approval process, and only approve those drugs that appear to be safe and that really represent an improvement over current therapies," Karen E. Lasser, MD, MPH, of Harvard Medical School, told WebMD in a previous interview.

Weisman agrees that there has been a shift in priorities at the agency. "They've moved from where applications were originally based on benefits, to more of an emphasis on safety, and now to a new hybrid approach with more of an assessment of the benefit-to-risk ratio."

Webster expects continued trends toward balancing risks and benefits. In fact, there are indications from the agency that its "one size fits all" approval process might become a thing of the past. "I think they might develop a segmented approach to drugs, where if you want the gold-plated FDA standard with a huge clinical trial to rule out adverse events, you can do that and market it appropriately. On the other hand, if you want to do a quick and dirty approach and get it to market sooner with the appropriate labeling, that might be a cheaper option," Webster says. "I think that will really benefit consumers, because they'll have more of a choice."

That certainly is not a trend that would please everybody. "Right now, it doesn't look good from a standpoint of getting the agency back to an independent regulatory authority where the public's health is its first priority," says Safich. "There needs to be ... regular congressional oversight and transparency of what is going on in the agency, and we don't have that."