Regulatory Focus™ > News Articles > Group Sues FDA, Seeking to Compel it to Withdraw Alzheimer's Drug from Market

Group Sues FDA, Seeking to Compel it to Withdraw Alzheimer's Drug from Market

Posted 06 September 2012 | By Alexander Gaffney, RAC 

Consumer advocacy group Public Citizen has filed a lawsuit against the US Food and Drug Administration (FDA) seeking to compel it to remove a particular dose of the Alzheimer's drug Aricept, which the group alleges is causing dangerous and potentially fatal side effects.

The lawsuit stems from a May 2011 Citizen's Petition filed by the group. The letter, addressed to FDA Commissioner Margaret Hamburg, calls for the 23 mg dose of Eisai's drug Aricept to be removed because it, "Significantly increased adverse events compared with the previously approved 10 mg dose," and did not meet, "efficacy criteria established by FDA as a condition of approval."

The drug, approved at the 23 mg dose to treat moderate Alzheimer's in July 2010, has been on the market since November 1996, when it was first approved at the 5 mg and 10 mg dose levels. In its Citizen's Petition, Public Citizen alleges Eisai failed to show the 23 mg dose exhibited statistically significant superiority over its predecessors, in violation of FDA's established terms of regulatory approval.

The group also called attention to higher rates of adverse events, and in particular vomiting, which it said were especially dangerous in Alzheimer's patients who are more susceptible to developing secondary complications such as pneumonia.

The combined evidence, "Leads to only one conclusion," concluded Public Citizen: "The 23 mg dose should be immediately withdrawn from the market." The group also called for statements to be printed on the labels of lower-dose versions of the drug contraindicating its use in doses greater than 20 mg per day.

An Interim Response, a Long Delay and a Lawsuit

FDA issued an interim response to Public Citizen in December 2011, authored by Jane Axelrad, associate director for policy at the Center for Drug Evaluation and Research (CDER), in which it asked for the group's patience while the agency worked through an, "Extensive review and analysis by Agency officials."

"We will respond to your petition as soon as we have reached a decision on your request," wrote Axelrad.

That decision has been too long in coming, said Public Citizen in its 5 September statement announcing the lawsuit. "FDA has dragged its feet for too long on [the] petition," the group wrote.

"Public Citizen is asking that the court declare unlawful the FDA's failure to act on Public Citizen's petition and order the FDA to issue a decision on the petition," the group explained. "By ignoring Public Citizen's petition for more than a year, the agency has ignored this responsibility and instead has chosen to support the profit interests of a large pharmaceutical company."

In a response to Bloomberg News inquiry, Eisai spokeswoman Marcia Diljak said the company, "Stands by the FDA's decision to approve Aricept 23 mg as a safe and effective treatment of moderate-to-severe Alzheimer's disease." Neither FDA nor US distributor Pfizer had any comment on the lawsuit.

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