Cracking down on fake drugs

Md. delegates, other states consider stricter safeguards in loosely regulated trade


When Florida passed a stringent law in 2003 meant to crack down on counterfeit-drug traffickers, those dealing in the illegal trade had to find new homes. At least two of them set up shop in Maryland, funneling fake prescription Procrit, an anti-anemia drug, through shell operations before they were eventually indicted.

The state'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.

"Maryland's laws have been notoriously weak," said Katherine Eban, who spent three years investigating the phony-pharmaceutical industry and published a book about it last year called Dangerous Doses.

But Maryland's not alone.

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.

Prompted partly by a few high-profile cases involving bogus drugs making it into local pharmacies, 11 states have tightened their legislation in the past few years to ensure the safety of the medicine supply. This year, 23 other states - including Maryland - and the District of Columbia have proposed bills of their own.

The Maryland bill was discussed yesterday during a hearing in Annapolis before the House Health and Government Operations Committee. If it becomes law, the Maryland Board of Pharmacy expects that more than half of its distributors - about 422 - will not apply for licenses under the new rules, based on experiences in other states.

"My concern is if we don't do something this year, we open ourselves - wide open - to counterfeiters that are being driven out of other states," Del. Joan F. Stern, the Montgomery County Democrat who filed the bill, said in an interview this week.

"It's a very serious problem, people can die, people can get sick," she said. "And the really scary thing is that most people don't know anything about this."

About one-tenth of all prescription drugs in the world are forgeries, according to the World Health Organization, and the Food and Drug Administration conservatively estimates that about 1 percent of the drugs in the United States are counterfeit. That means about 35 million prescriptions every year are filled with something other than the prescribed drug.

"We have the most intense regulations for the manufacturing of drugs; every aspect is scrutinized," 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."

Stern's bill, which is co-sponsored by about 50 delegates, would strengthen the oversight powers of the Maryland Board of Pharmacy by putting in place a strict licensing process for drug distributors, requiring background checks and that drugs have a paper trail, called a "pedigree," showing their every move from manufacturer to retailer.

It would also provide for penalties of up to 25 years in prison and a $500,000 fine for those caught tampering with the drug supply, and put an inspector in place whose job it would be to check up on distributors and possibly test their products for authenticity.

Stern's proposal is based in part on rules developed by the National Association of Boards of Pharmacies, based in Illinois. In 2003, the FDA asked the body to update its advisory licensing rules to help prevent counterfeit drugs from infiltrating America.

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 association.

"The states licensed wholesale distributors, then relied upon the industry to self-regulate to a large extent," said Catizone, who sent a representative to testify at yesterday's hearing in Annapolis. "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."

Of about 6,000 licensed drug distributors in the United States, three major ones - Pennsylvania's AmerisourceBergen Drug Corp.; California's McKesson Corp., which has a distribution center in Landover; and Ohio's Cardinal Health Inc. - handle 90 percent of the supply.

Most legislators and pharmacy groups would prefer that drugs were sold in a very simple process, going from manufacturer to wholesale distributor to retailer, such as Rite Aid's pharmacy. And most drugs do follow this path. But there's also a secondary market dealing in prescription drugs, and that's where the problems arise.

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