Conn. attorney general sues FDA over OxyContin warnings

HARTFORD, Conn. Connecticut Attorney General Richard Blumenthal has filed a lawsuit against the Food and Drug Administration in relation to his attempt to get the agency to add stronger warnings for the Purdue Pharma pain killer OxyContin.

Blumenthal said that continued inaction by the FDA on OxyContin warnings and other matters could be devastating because, as the U.S. Department of Justice has confirmed, abuse of prescription drugs such as OxyContin has become the greatest drug threat in the Northeast region.

Blumenthal filed a citizen’s petition in January 2004 as a result of his 2003 investigation into Purdue Pharma. This lawsuit asks for the court to compel the FDA to act on the petition.

In 2004, Blumenthal petitioned the FDA to:

• Strengthen OxyContin’s black box warning to warning to expressly reinforce the FDA approved dosing regimen and to add specific information regarding the potential dangers associated with an off-label dosing schedule.
• Issue a “Dear Healthcare Professional” letter to inform physicians of controlled substances about the potential risks of prescribing OxyContin at dosing intervals that are shorter than the FDA-approved 12-hour dosing schedule.