The establishment of "risk management" programs for pharmaceuticals may become a routine part of the FDA approval process.

"We really need to think about risk management" in responding to concerns about drug safety, Center for Drug Evaluation & Research Director Janet Woodcock, MD, told a Food & Drug Law Institute meeting June 5 in Washington, D.C.

"It used to be that we would review the data and FDA would decide whether the benefits outweighed the risks, if the drug was used in an ideal fashion, [and that was] laid out on the label," Woodcock said. "Now we know that is not happening."

Previously, "what we would do is we would kind of throw the drug and the label out there into the community." FDA's approach to safety problems was "send them in on your spontaneous reports and we would look at them."

Instead, FDA and sponsors need to ask, "What additional steps can be taken? What can be done to make a newly approved drug as safe as possible?"

Woodcock cited thalidomide (Celgene's Thalomid) as the best example of the power of a dedicated risk management program to allow for marketing of a product that would otherwise not be approved.

Celgene put together an educational program, used restricted distribution and established a registry to track the effectiveness of the risk management plan in preventing patients from becoming pregnant.

While FDA has used risk management programs on a number of occasions for products with obvious safety concerns, Woodcock's comments suggest that the agency is focusing on risk management as a tool for broader use to address concerns about drug safety.

Two high profile examples of products that reflect FDA's interest in broader use of risk management programs are Glaxo Wellcome's irritable bowel syndrome Lotronex and the Population Council's abortifacient mifepristone.

FDA is planning an advisory committee meeting to discuss a risk management program to address post-marketing reports of ischemic colitis with Lotronex. For mifepristone (RU-486), the agency is receiving criticism based on its plans to restrict distribution of the drug (¹ Also see "Lotronex Advisory Committee Will Discuss Program For Ischemic Colitis Risk" - Pink Sheet, 12 June, 2000.).

Risk management programs are not necessary for all drugs, Woodcock added. For many drugs, "their instructions are fairly simple and the risks are fairly straightforward. You don't need additional interventions."

CDER recently conducted a two-day risk management training program for review staff using outside experts in the topic, Woodcock reported.

The agency found that "other industries are way ahead of us all in this." Woodcock specifically cited the airline and nuclear power industries as better at risk management.

"I think we've all been obsessed over the past 20 years with figuring out whether [drugs and devices] work," Woodcock observed. "Been there. Done that. We know how to figure out whether drugs work."

"I think the challenge in the next couple decades is to figure how these products and how this environment can be made as safe as possible, something other industries really are several logs of quality better at than ours," Woodcock said.

"I think we in CDER have to recognize that we've done a fairly dismal job in communicating the risks of pharmaceuticals to both the medical practitioner public as well as consumers," Woodcock continued. However, "I think the pharmaceutical industry and the medical device industry also have taken part in this."

"What we haven't really formally finished taking on...is the really fundamental question, which is what else can be done to manage the risk of pharmaceuticals?"

FDA continues to seek additional resources to address post-marketing safety. At the FDLI meeting, Center for Devices & Radiologic Health Director David Feigal, MD, cautioned that the focus on product approvals under the user fee system limits FDA's ability to address safety and efficacy throughout a product's entire life cycle (² [A#00620240006]).

Rx Risk Management Programs May Become Routine Element In FDA Reviews

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