Pharmacy & Therapeutics- July 2008 - (Page 396) PROFILE FDA’s Janet Woodcock Riding High CDER Director Wins “Wows” Amid Agency Woes Stephen Barlas epresentative John Dingell (D-Mich.), the irascible, octoto 2005—agrees that this has been the most contentious period genarian Democratic chairman of the House Energy for the FDA since she has been at the agency. She points to a and Commerce Committee, normally sinks his teeth generic drug scandal in the late 1980s but calls that event into Bush administration officials like a lion falling on a springmore of “a tempest in a teapot,” compared with what is going bok. At a very contentious hearing on April 29, he tore into on now. FDA Commissioner Andrew von Eschenbach, MD, for spout“I regard the heparin problem as a landmark type of event,” ing “hooey.” Mr. Dingell ranted, “Let’s come down to the nutshe adds. “It demonstrated that an essential drug used everycutting stage. I don’t want to weasel words.” day all over the health care system can be contaminated. That But here John Dingell was two weeks later, listening to Dr. is pretty bad.” von Eschenbach’s deputy, Janet Woodcock, It is not often that one hears a top federal MD, and purring like a kitten. official admit to a serious mistake. Democrats “Again, I want it known that I appreciate Dr. and Republicans on Capitol Hill appreciate Dr. Woodcock’s candor,” intoned Mr. Dingell, Woodcock’s attempts to push candor to the whose committee has jurisdiction over the limits. Referring to her colloquy with RepresenFDA. “To her credit, she has stepped forth in tative Dingell on May 1, Bill Hubbard, longtime the midst of a public health crisis to deal hon(now retired) Associate Commissioner at the estly with Congress. How I wish others in the FDA, who was also testifying at that hearing administration showed the same vigor, responand who worked with her at the FDA, says: siveness, and leadership.” “Janet was willing to speak her mind, which Why was John Dingell stroking a Bush adis refreshing and also somewhat unusual. Usuministration official? ally, administration witnesses have to spout the A few days before, at a different hearing, Dr. party line. She is very popular now on Capitol Woodcock, an internist and rheumatologist, Hill, but she may have ticked off people in the Dr. Janet Woodcock, MD, had supplied what Dr. von Eschenbach had Bush administration.” Director, Center for Drug refused to furnish: an estimate that the FDA Pressed as to whether anyone in the White Evaluation and Research at the would need another $225 million per year to Food and Drug Administration. House has come down on her for making nice inspect foreign drug-manufacturing firms such with John Dingell, she demurs. “The chips will as the ones in China—the source of the contamfall where they may,” she adds. inated active ingredient in heparin that has caused 81 deaths Director Woodcock is also apparently willing to take more in the U.S. so far. than just rhetorical risks. Although she is well regarded by the Heparin is just the most recent FDA drug disaster in a string drug industry, a few noses there might have gotten out of of misadventures that started with Merck’s rofecoxib (Vioxx) joint when the FDA decided on April 28 not to approve Cordapand moved on to other public relations fiascos involving the tive, Merck’s new cholesterol-lowering medication. Analysts selective serotonin reuptake inhibitor (SSRI) class of antiwho had been predicting that the drug could easily top $1 bildepressants, GlaxoSmithKline’s rosiglitazone (Avandia), and lion in sales were surprised by the news that the FDA sent a too many others to mention. In all those instances, including “Not Approved” letter to Merck. Dr. Woodcock refuses to disheparin recently, FDA regulatory oversight has been, if not cuss the case but explains, “Every year we learn more, and we quite blind, then fuzzy enough to defy even the most talented apply it moving forward.” optometrist. Never has the FDA’s regulation of drugs been Ron Rodgers, a spokesman for Merck, says, “The question held in lower regard by Congress and the public. we sometimes get is whether the FDA is changing the standard But in a seeming paradox, amid the agency’s woes, its top for approval. We believe the rejection had to do with the ‘scidrug regulator has been getting “wows.” In her roomy sixthence’ and we hope to get an understanding of the agency’s floor office in the FDA’s new office building just outside the reasoning in an upcoming meeting.” Beltway off New Hampshire Avenue in suburban Maryland, Asked whether the black eyes the agency has earned in the Dr. Woodcock, who has worked at the FDA in one position or past few years over Vioxx, SSRIs, and other drugs led the another since 1986—including an earlier stint as director of the FDA to make a statement to the public by canning Cordaptive, Center for Drug Evaluation and Research (CDER) from 1994 Dr. Woodcock laughs and says, “We don’t make decisions that pander to public approval.” Heparin is the latest, if not the most disturbing, drug disaster Stephen Barlas is a freelance writer based in Washington, DC, she has had to live through at the FDA. After taking over as who covers issues inside the Beltway. Director of CDER in 1994, she was kicked upstairs in 2005 and given the title of deputy commissioner and chief medical Accepted for publication May 22, 2008. R 396 P&T® • July 2008 • Vol. 33 No. 7
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