Plan to Reduce Misuse, Abuse of Painkillers Not Strong Enough: FDA Panel

An FDA advisory panel has shot down the federal drug regulatory agency’s proposal to address the increasing misuse and abuse of powerful painkillers and narcotics, saying the plan is too weak and needs to be strengthened. 

The panel of outside experts voted 25 to 10 against a plan developed by the FDA and drug makers to reduce the abuse of drugs like OxyContin and fentanyl, which have been increasingly associated with drug overdose, addictions and illegal narcotic activities. The panel members criticized the plan for not requiring mandatory training on prescribing the narcotics.

The FDA created what it called a class-wide opioid Risk Evaluation and Mitigation Strategy (REMS) to help address a growing drug abuse and overdose problem in the United States. The FDA proposed to approach the problem by educating doctors on proper dosage and ferreting out patients likely to misuse the drugs, as well as monitoring their ongoing pain management for signs of abuse and other problems. The agency also planned to educate patients in how to safely use, store and dispose of the powerful painkillers.

However, the advisory panel felt that the plans do not go far enough because they do not make training mandatory for prescribers. While the agency itself cannot make such training a requirement of doctors, the FDA can force drug makers to make training mandatory for doctors to prescribe their products. Although the FDA is not required to act on the panel’s recommendations, it usually does.

Reports published earlier this year in the American Journal of Preventative Medicine found that prescription drug overdoses have surpassed automobile accidents as the leading cause of unintentional injury death among people between the ages of 35 and 54, and found that prescription drug overdose rates are now 65% higher than they were during the period of 1999 through 2006.

Most of the FDA’s focus has been on OxyContin, a form of the narcotic oxycodone that is designed to release the painkilling medication into the bloodstream gradually over a 12-hour period. Approved by the FDA in 1996, drug abusers quickly discovered that the pill could be crushed and snorted or inhaled for an instant high. Often referred to on the street as “Hillbilly Heroin” or “Killers,” the drug has been linked to hundreds of drug overdoses and deaths.

The pill is the best-selling prescription pain medication in the United States, with more than $2 billion in annual sales. In April, the agency approved a new form of OxyContin pill that is supposed to be more resistant to tampering.

In 2007, Purdue Pharma executives plead guilty to criminal charges that they made false and misleading statements downplaying the risk of Oxycontin addiction to doctors. Sales representatives were told to tell doctors that the drug did not cause euphoric highs and was not as addictive as other pain medications. They also told doctors the drug did not cause withdrawal symptoms.