FDA’s Handling of Lotronex ‘Disturbing,’ Los Angeles Times Says

Although the FDA may have "good reason for a limited reintroduction" of Lotronex, GlaxoSmithKline's treatment for irritable bowel syndrome, a Los Angeles Times editorial says that such a decision should "be made only with proper oversight by an FDA that is subject to public scrutiny." The editorial notes that Dr. Janet Woodcock, director of the FDA's drug evaluation center, has privately "conferred" with Glaxo officials on ways to "stage" an advisory committee hearing to "minimize criticism" of the drug. Noting that the drug was pulled from the market last year after being indicated in five deaths and linked to "life-threatening complication," the editorial says it is "disturbing" that the FDA "seems to be turning a blind eye to science." The editorial says that the agency's handling of Lotronex gives the impression that the FDA "colluded with the industry [it] oversees to increase the market share of a product that last year generated sales topping $50 million." The editorial concludes: "It is fine for Woodcock to maintain a collegial relationship with the pharmaceutical industry. The industry is not the FDA's enemy, and getting helpful drugs on the market quickly is in everyone's best interests. But taxpayers pay Woodcock to protect sick people from dubious drugs, not to help companies market them" (Los Angeles Times, 5/31).