Continuing legal battles between the Drug Enforcement Administration and Cardinal Health have raised questions about federal drug policy and the role of distributors.
Continuing legal battles between the Drug Enforcement Administration (DEA) and Cardinal Health have raised questions about federal drug policy. DEA has spent years pushing pharmaceutical wholesalers to accept responsibility for the illicit use of the products they distribute to hospitals, pharmacies, and other licensed facilities. The industry is pushing back.
The DEA takes the opposite view: Cut off supply at the top and distribution stops at the bottom.
"DEA has sought to disrupt the supply chain that makes diversion...possible," said agency administrator Michele Leonhart during Congressional budget testimony in March 2008. "DEA has undertaken an important initiative to educate wholesale distributors, and when necessary, pursue administrative, civil, or other criminal action against wholesalers that distribute excessive amounts of controlled pharmaceuticals."
"The DEA doesn't fundamentally understand the legitimate drug distribution system in the United States," Fein told Drug Topics. "The DEA is misapplying lessons from the illicit drug trade to the legitimate channel. That is creating enormous problems for the industry. DEA is treating drug wholesalers as if they are drug dealers and asking wholesalers to become the judge, jury, and executioner on behalf of the government."
The DEA did not respond to requests for comment. Nor did the other 2 major wholesalers, AmerisourceBergen and McKesson. All 3 wholesalers have run afoul of DEA enforcement in recent years. The common issue, Fein said, is sales of what the agency considered to be excessive levels of OxyContin (oxycodone, Purdue) and other controlled substances, usually to chain or independent pharmacies with valid DEA distribution licenses.
In early February, DEA pulled controlled substance distribution authorization at Cardinal's Lakeland facility due to what the agency called "an imminent danger to the public safety." The agency also halted controlled substance sales at 2 independent pharmacies and 2 CVS outlets in Sanford, Fla., an Orlando suburb.
Cardinal obtained a temporary restraining order on the license suspension and resumed narcotics shipments to more than 2,500 other hospital and pharmacy customers around the state.
The DEA won the next legal round in late February and had its suspension order reinstated. Cardinal began supplying Florida customers from nearby distribution centers and filed an appeal with the U.S. Court of Appeals in Washington, D.C. The case could be heard later this spring.
"Everybody has to have a responsibility along the supply chain to ensure that there is not inappropriate narcotic use," Perlman said. "The DEA is on the right track to try to stop abuse, but they stopped the whole train at the first stop along the line. If you stop these drugs at the first station, they will never get down the line to hospitals and pharmacies and patients who need them. That's the public policy question we're not discussing."