Life Sciences

CT AG sues FDA over OxyContin

Pharma Compliance Alert, April 9, 2008

Connecticut Attorney General Richard Blumenthal is suing the FDA to force the agency to put tougher warnings on the painkiller OxyContin, according to a statement on his Web site.

Blumenthal’s quest for stronger warnings about OxyContin began in January 2004, when he filed a citizen’s petition with the FDA. In his 2004 petition, Blumenthal asked the FDA to:

  • Strengthen OxyContin’s black box warning to reinforce the FDA approved dosing regimen
  • Add specific information to the black box warning regarding the potential dangers associated with an off-label dosing schedule
  • Issue a “Dear Healthcare Professional” letter to inform physicians about the potential risks of prescribing OxyContin at dosing intervals shorter than the FDA-approved 12-hour dosing schedule 
In his statement, Blumenthal criticized the FDA for “disregarding dangers of adverse reactions and side effects, as well as abuse and addiction, by failing to require stronger black box warnings or issue a safety alert or public health advisory.” He also claimed the FDA “irresponsibly and illegally ignored the need for warnings about OxyContin prescription practices that promote abuse and addiction.”

 

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