Miami Herald - Wednesday March 5, 2003
Andrea Robinson, arobinson@herald.com

The bottles were relabeled at a strength 20 times the medicine's actual potency, said the report, which urged the Florida Legislature to increase criminal penalties against drug wholesalers who peddle counterfeit or diluted prescription medicine.

The oversight report authors noted that as many as 55 of the 1,458 legal wholesalers in Florida are suspected of selling counterfeit drugs or selling medicine obtained fraudulently. More than 70 percent of the wholesalers are located in South Florida, particularly Miami-Dade.

The state's Office of Program Policy Analysis and Government Accountability said Florida's current laws are too weak to combat a growing wave of unscrupulous drug wholesalers putting vulnerable patients at risk.

The report comes amid an ongoing grand-jury investigation into drug wholesalers' handling of expensive medicines for cancer and HIV/AIDS patients.

The oversight agency's report said counterfeiters -- and some legitimate wholesalers -- relabel drugs to hide the fact they have expired, have previously been sold or were illegally imported into the United States.

"That's when things go from bad to worse," said one source familiar with the grand-jury probe. "It's one thing to buy drugs that have been stolen, but [haven't been changed]. But when they are relabeled that's when you're buying something that isn't what it's supposed to be."

In other instances, the report said, criminals produced substances that lacked active ingredients but labeled and passed them along to pharmacies as legitimate.

Similar contentions were made last week in a statewide grand-jury report that blasted the state Health Department, accusing it of not doing enough to protect medical consumers from crooked wholesalers.

The report said that the number of criminal wholesale drug cases have jumped from none in the 1990s to more than 50 since 1999.

Last year, the state health department shut down three wholesale companies -- two in Miami-Dade and one in Pembroke Pines -- for improper handling of medicines.

"It's a pretty significant problem," said Jennifer Johnson, an oversight agency staffer.

The Florida Attorney General's Office said questionable medicines from some wholesale warehouses have wound up on pharmacy shelves, although the extent of the problem is not known.

In the case of the 110,000 fake bottles of medicine investigators recovered less than 10 percent of the counterfeit drugs. The drugs were resold in the wholesale market with forged documents, passing through four states and four wholesalers.

"People are getting bad drugs and it may be killing them," said Mark Schlein, a director of the attorney general's Medicaid Fraud unit.

Schlein said improperly sold drugs are costing the state's Medicaid program millions of dollars each year.

"We can never afford that problem, but we certainly can't afford it when the state is facing fiscal constraints," he said.

The oversight agency's report recommended that lawmakers toughen the drug wholesale permitting process to ensure that only legitimate wholesalers do business in the state.

It also urges lawmakers to clarify state law requiring documentation that traces drugs back to manufacturers.

So-called pedigree papers are a written sales history that identifies each purchaser of a particular drug back to its manufacturer. However, according to the report, wholesale industry practices allow drugs to pass through numerous wholesalers before reaching retailers, such as pharmacies, without pedigree papers.

The Pharmaceutical Distributors Association, which represents wholesalers, said it supports calls for reforming the wholesale drug industry, especially tougher licensing. But it opposes requiring additional drug-sale paperwork.

"The reason crooks can handle such prescription medication is simple," said PDA spokesman Bruce Krichmar. "The crooks have been licensed by the state. Tighter licensing, not paperwork, will take care of the crooks."

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