Consumer advocacy group, Public Citizen, is suing the FDA for taking an inordinate amount of time to respond to their request to have the highest dosage of a popular Alzheimer’s medication banned following reports on its ineffectiveness. This is likely to be one of the more important drug safety cases in recent years.

According to Public Citizen’s press release, the FDA has admitted in its own statistical analyses that the highest dose of Aricept has no additional benefit for controlling moderate to severe Alzheimer’s symptoms in patients. This now has to be weighed against the potentially severe side effects of the medication, including severe nausea and vomiting, which Public Citizen asserts can cause “…pneumonia, massive gastrointestinal bleeding, esophageal rupture or death.”

Public Citizen filed a petition with the FDA in May 2011, asking that they stop sales of the 23 mg dose of Aricept, and include warnings on any product to be sold in the future. The FDA has not made a decision, so Public Citizen has filed their lawsuit. They are asking that a judge declare the failure to act as illegal, and to order the FDA to take action within 30 days. Taking action could be as simple as deciding whether to follow the petition’s guideline — it does not have to be accepted, merely responded to, which makes their failure to answer somewhat confusing.

“By ignoring Public Citizen’s petition for more than a year, the agency has ignored (its) responsibility,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “During the past year alone approximately 350,000 prescriptions have been filled in the U.S. for Aricept 23.”

As is typical for government agencies, the FDA issued a statement saying they do not comment on ongoing or impending litigation, so there is no word on what their response or legal strategy will be in this case.

The FDA did file a response to the petition, but only went as far as saying they were unable to come to a decision, and would get back to Public Citizen. This level of lackluster response ultimately prompted the advocacy group’s more vigorous actions.