Attorney General Richard Blumenthal filed a lawsuit in federal court today against the U.S. Food and Drug Administration (FDA) to force the agency to act on his 4-year-old citizen petition seeking stronger warnings related to 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 the citizen petition in January 2004 as a result of his 2003 investigation into Purdue Pharma L.P., OxyContin's manufacturer.
OxyContin is a controlled-release narcotic designed to deliver a consistent level of oxycodone over a 12-hour period. Despite information on the drug's package insert that the FDA recommends only 12-hour dosing, Blumenthal's investigation has revealed that Purdue Pharma had strong evidence showing that shorter dosing is rife with hazard and approximately 20 percent of all OxyContin prescriptions were written for dosing intervals of eight hours or less.
Although this powerful painkiller can benefit many patients if used properly, prescribers and patients cannot make sound treatment decisions without full knowledge of the risks and benefits of prescribing OxyContin, Blumenthal said.
Today's lawsuit, filed with the U.S. District Court, seeks a court finding that the FDA's failure to act on the petition was unlawful, and an order compelling FDA action on the petition.
"The FDA has irresponsibly and illegally ignored the clear need for warnings about OxyContin prescription practices that promote abuse and addiction," Blumenthal said. "Prescription narcotic abuse of drugs like OxyContin has become the biggest drug threat in the Northeast, causing countless cases of diversion and addiction tragedies. Twenty percent of OxyContin prescriptions are for doses at dangerous eight-hour time intervals or shorter, but the FDA remains oblivious and obtuse. These ongoing practices produce, in effect, an extra dose a day. After four years of proven dosing dangers and Purdue Pharma criminal convictions, the FDA seems in denial. The agency has failed to approve or even deny our 4-year-old petition seeking strengthened warnings. We now need to resort to a court order to force the FDA to take action to warn and protect patients.
"The FDA is 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. The FDA has a legal and moral responsibility to ensure that providers and patients fully understand the potential dangers of improperly prescribing OxyContin. Inaction by the FDA is completely inexplicable and unacceptable when public health and safety are clearly at risk."
Purdue Pharma's internal documents confirm that many physicians, particularly family practice and general practitioners, did not understand OxyContin's controlled release delivery system and accordingly were prescribing the drug inappropriately.
As one company document cautioned sales representatives, "[l]ook especially hard at FP/GP percentages [of off-label prescribing] they are the worst offenders, and therefore require the most education on Oxy's dosing."
On Jan. 23, 2004, Blumenthal petitioned the FDA to require that Purdue Pharma:
Strengthen OxyContin's black box 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.
In addition, or as an alternative, Blumenthal requested that the FDA disseminate warnings concerning the OxyContin dosing issues through a Safety Alert, Public Health Advisory, Talk Paper or Urgent Notice.
Blumenthal thanked those in his office who worked on the investigation - Assistant Attorneys General Christopher Haddad, Robert Deichert, Karen Haabestad, Arnold Menchel and Michael Cole.
tag: Hillbilly Heroin, OxyContin, FDA, oxycodone, painkiller, Purdue Pharma, controlled substances, Safety Alert, Public Health Advisory,
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