Regular readers know that I've been very critical of the DEA's aggressive and misguided pursuit of pharmaceutical manufatcurers and wholesalers. For perspective on this current dispute and Cardinal's historical troubles, see February's Cardinal Fights a Misdirected DEA.
Read on for some more thoughts on this issue and details of how Senator Chuck Grassley and Senator Sheldon Whitehouse are trying to shine a light on the DEA's impact on drug shortages.
In a Bloomberg Business Week hit job story on Cardinal, I stated: "Many people, including me, believe they are overstepping their bounds in going after Cardinal in this manner." You should also read Scott Gottlieb's excellent editorial The DEA's War on Pharmacies—and Pain Patients.
I'm not sure what went on behind the scenes, but Cardinal seems to have escaped with a relatively minor concession. So, I guess cooler heads prevailed.
Coincidentally (or not?), Senators Grassley and Whitehouse yesterday requested that the Government Accountability Office study the role of the DEA in drug shortages and recommend potential fixes. See Balancing Medicine and Drug Control. Key quote:
"The Drug Enforcement Administration sets quotas for drug companies that manufacture controlled substances and in effect limits how much product they are allowed to make. Since the drug shortage crisis developed, controlled substances are frequently on the drug shortage list of the Food and Drug Administration.By chasing wholesalers and manufacturers, the DEA is simply going after the wrong actors in the U.S. drug distribution system. The real problems originate with consumers who abuse prescription medications, the physicians who operate “pill mills,” and the pharmacies that knowingly participate in diversion and abuse. Let's hope the GAO can help shine some light on the supply chain impact of overzealous prosecution.
The Drug Enforcement Administration has to walk a fine line between managing dangerous controlled substances and making sure there are adequate supplies for legitimate medicine."