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Legislative fight brews over prescription drugs

At issue is a new law that tracks the path of medicines. Some want to stop it from taking effect.

TALLAHASSEE - Most people don't think much about the path a pill takes from the factory, to the pharmacy, to the patient who may need it to stay alive.

But what happens to critical medicines along that path is the subject of a fight in the Legislature over an effort to create a paper trail to try to ensure the safety of those drugs.

Some drug distributors say a rule set to take effect in July aimed at making the distribution chain safer won't really do so, but instead will only slow down drug delivery. They're backing a bill that would keep the rule from going into effect.

On the other side is a coalition of consumer advocates, joined by Attorney General Charlie Crist and groups such as the American Cancer Society - and backed by companies that stand to benefit financially from the rule - who are fighting to make sure the more stringent rule takes effect.

The issue first came to legislative attention in 2003, after a statewide grand jury reported that Florida had a problem with counterfeit drugs showing up in drugstores.

Investigators found that a small percentage of drugs was going through a maze of wholesalers that most consumers, or even pharmacists, didn't know about, and in some cases the drugs weren't good by the time they hit the shelves, or worse, were actually tampered with to boost costs.

So in 2003 the Legislature tried to make the supply chain safer, passing a law that established more stringent enforcement and oversight of drug distributors. The companies that distribute the drugs say that law is working well, with tougher licensing requirements including criminal background checks and physical inspections of distribution facilities.

That legislation also required that drug distributors create a paper trail of each step in the distribution chain, known as a pedigree, for drugs that don't come straight from the manufacturer and are therefore most likely to be counterfeited.

If the drugs come straight from the drugmaker, no pedigree is currently needed.

But starting July 1, that is set to change, with the rule expanding to require pedigrees for all drugs, even the 90 percent that come straight from the manufacturer.

"For some reason, some participants in the supply chain do not want this to go into effect," said Sandra Stovall, executive director of the group Safe Drugs Now, the coalition pushing for the expanded pedigree rule.

There are several reasons some drug distributors don't want it to expand, said Amanda Forster, a spokeswoman for the Healthcare Distribution Management Association, which represents many distributors.

For one, it won't work, she argued.

"It's a really old-fashioned and manual process," she said. "And if you can counterfeit the drugs you can counterfeit a pedigree."

Forster also said the trade group opposes expanding the pedigree requirement because it will create a paperwork headache for the companies, and could slow down distribution.

The distributors' trade group is backing a bill (HB 1397) sponsored by Rep. Ed Homan, R-Tampa, that would delay the expansion of the pedigree rule.

"These industries, I think, can go ahead and put this into place," Crist said. "Floridians will be better served if the (law) . . . is implemented on schedule."

Backers of the pedigree rule point out that some drug wholesalers have said they can meet the new requirement and plan to.

Homan's bill hasn't picked up much traction. It has been referred to three committees, but so far hasn't had a hearing.

[Last modified March 24, 2006, 02:15:43]