Counterfeit drugs
Want to distribute counterfeit drugs? Come to Maryland!
( Full text )
Maryland's Board of Pharmacy has no inspector, rarely does background checks, allows distributors to work out of their homes and hands out drug-distribution permits - 722 of them in total - after less scrutiny than that given when licensing beauticians.But if you don't live here, don't feel smug.
Most states' laws governing who can buy and sell prescription drugs are lax, requiring little more than a filing fee and a promise to follow certain storage rules. And there's little oversight at the federal level, which has long delayed a program designed to track drugs through their sales channels. ...
"We have the most intense regulations for the manufacturing of drugs; every aspect is scrutinized," [investigative writer Katherine] Eban said. "Then the drug leaves the loading dock of the manufacturer and they just fall into the black hole. The [FDA] says, 'We don't regulate the supply chain.' That was incredible to me." ...
The previous guidelines and state laws, most of which are still in place today, are a "travesty," said Carmen A. Catizone, executive director of the [National Association of Boards of Pharmacies].
"The states licensed wholesale distributors, then relied upon the industry to self-regulate to a large extent," said Catizone .... "What ensued was a significant threat to basic safety. ... There were distributors that were counterfeiting and tampering with drugs and patients were actually killed because of this." ...
In 2002, [16-year-old liver transplant patient Timothy] Fagan was prescribed a drug meant to boost his red blood cell count, but wound up taking a fraudulently labeled one he bought from his local CVS pharmacy. The drug traveled through multiple hands, at one point being stored in paint cans and shuttled through a Miami strip club, before making it to Fagan's door [on Long Island] as part of the $32 billion counterfeit drug industry. ...
[A New York] bill, dubbed Tim Fagan's law, will likely face the same difficulties in becoming law that the FDA has faced in implementing portions of the Prescription Drug Marketing Act of 1988. That statute required the same "pedigree" that would show every move a drug made after it left the manufacturer. The drug industry complained that the requirement was burdensome and expensive, and the FDA has had a stay on the rule ever since it was introduced. ...
( Full text )
