Latebreakers: February 19, 2007

Dual eligibles sue Part D

A Northern California judge is allowing a suit against HHS secretary Michael Leavitt and has granted the suit class-action status. The case is narrowly focused on the problems encountered by dual-eligible patients who were switched from Medicaid and other health programs to the Medicare Part D drug benefit. Many dual-eligible beneficiaries have had problems enrolling in the program, gaining benefits, and receiving subsidies to augment their coverage. The suit alleges that the difficulties result from structural problems with the program that have not been adequately addressed by the secretary. "We were suing the government for designing this program in such a way that it treated the most vulnerable Americans so callously," explained Jeanne Finberg, of the National Senior Citizens Law Center, which filed the suit. "This lawsuit and the judge's orders are a testament that there are some very serious problems for the most vulnerable Americans."

Labeling changes announced for Ketek

Petition seeks ban of risky OCs

Consumer advocacy group Public Citizen calls third-generation oral contraceptives (OCs) containing desogestrel dangerous, with double the risk for venous thrombosis of other birth control pills. The group has petitioned the FDA to ban these products, citing three independent studies that showed the pills had about twice the risk for blood clots as second-generation OCs. Barr Pharmaceuticals noted that the FDA-approved package inserts that come with their desogestrel-containing OCs discuss the potential risk of venous thrombosis in detail. However, the desogestrel-containing OCs also provide significant benefits to the women who use them and the FDA has determined that they should be available to women whose physicians determine such OCs are appropriate for them.

FDA gives nod for orlistat to go OTC