Risk Management Mayhem

  • by: |
  • 08/21/2006

Want to know what getting new drugs will be like if folks like Sid Wolfe, Chuck Grassley, Christoper Dodd get ahold of the FDA? Want an insight as to how a 21st century FDA will respond to the needs of patients if user fees are poured into more staff and reporting requirements for managing the risks of drugs after market? Read this article in the Chicago Sun-Times, Acne drug registry irritates patients: Rules for avoiding pregnancy delay treatment - 21 August 2006 Chicago Sun-Times - By Jim Ritter. Isotretinoin can wipe out severe acne but it can cause birth defects in pregnant women. “…Despite patient education efforts, at least 2,000 isotretinoin users have gotten pregnant over the years, “and this may be the tip of the iceberg,” according to March of Dimes.

Female patients must have pregnancy tests before, during and after taking isotretinoin, take two forms of birth control and answer questions on a Web site. Prescriptions last only 30 days, and must be filled within seven days of an office visit.

But critics say that iPledge, though well-intentioned, is cumbersome and poorly administered. Callers to the iPledge hotline have waited more than an hour to get through. Many patients have been unable to access their mandatory iPledge accounts. And even men and women who can’t get pregnant are required to enroll in iPledge, although their requirements are less stringent. In a recent letter to the U.S. Food and Drug Administration, Sen. Dick Durbin (D-Ill.) and seven other senators wrote: “Our offices continue to receive numerous complaints from doctors, patients and pharmacists about the inflexible and confusing requirements that have denied access to the drug to thousands of qualified patients.”

My advice: Don’t call Senator Durbin. Call Senator Grassley or Public Citizen or even Senator Enzi. If you think Ipledge is Irritating, just wait till it is applied for which every medicine the FDA thinks it needs political cover. Nothing like turning the Critical Path into an obstacle course for patients.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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