Legislation removes crux of drug act
The bill allows prescription drug distributors to avoid producing a paper trail, a key requirement of a 2003 law.
By JENNIFER LIBERTO
Published May 13, 2006
TALLAHASSEE - House Bill 371 was bland. Noncontroversial. A feel-good effort backed by cancer groups who wanted a state donation program so pricy that unused cancer drugs might go to needy cancer patients instead of the trash can.
But in the last minutes of the Legislative session last week, it morphed into a controversial gutting of a 3-year-old state law trumpeted by Attorney General Charlie Crist that tracks prescription drugs and combats counterfeiting.
Gov. Jeb Bush has not indicated a position on the bill yet.
The Prescription Drug Safety Act of 2003 called for requiring "pedigree papers" to travel with each pharmaceutical as it moved from manufacturer to wholesaler to retailer so each party was certain of the drug's whereabouts and potency.
Scheduled to take full force July 1, the program was heralded as the first of its kind in the wake of a damning statewide grand jury investigation, which found fake versions of lifesaving drugs had reached the shelves of legitimate pharmacies.
Just in time for the deadline, the Florida Legislature carved out a huge loophole that basically allows big chain drugstores and their middleman wholesaler distributors to ignore the more pressing part of the mandate, a requirement to produce detailed paper trails on all prescription drugs.
The new legislation allows big wholesale distributors who promise on paper that they buy direct from manufacturers and sell to pharmacy warehouses to skirt the original 2003-required paperwork trail. That paperwork requires, among other things: factory identifying numbers, invoice numbers and shipping information.
The loophole applies to most, but not all, wholesale distributors. Smaller secondary wholesale distributors that make money by buying and selling among themselves and would still be required to meet the mandate.
The policy reversal got no discussion in the Senate, where it passed 38-0, and 10 minutes of debate in the House, where it passed 93-20.
The issue pits special interests against each other: the Florida Retail Federation, Healthcare Distribution Management Association and the major drug wholesalers vs. "pedigree technology" companies like Massachusetts-based SupplyScape that makes tracking equipment.
Chief supporters of the new legislation, including Rep. Ed Homan, R-Tampa, who helped craft the original 2003 law, say that wholesalers shouldn't be required to produce more detailed pedigree papers until better technology that tracks individual bottles becomes more affordable and available.
Several lawmakers who voted against the bill said they were annoyed that the legislation got so little vetting and was rushed through at the last minute.
"This bill dilutes consumer protection, and I think everyone should be aware of that at 11:52 p.m.," said Rep. Mark Mahon, R-Jacksonville, minutes before the session ended on May 6.
On Friday, Attorney General Charlie Crist's office said he is asking the Department of Health for their opinion on whether the bill weakens consumer protection. Crist has held press conferences blasting efforts to weaken the act. But since the act's teeth have been removed, Crist's office says it has yet to decide its position on the bill.
"He's not backtracking," Attorney General's Office spokeswoman JoAnn Carrin said. "He stands firm on the safety of consumers, but we need to evaluate the whole package and see what the impact is going to be. If the drugs can be safely delivered to consumers, that's what he wants to make sure happens."
Crist also is running as the Republican candidate for governor. One of the chief lobbyists who helped cement the last-minute bill was Brian Ballard, who represents Healthcare Distribution Management Association in Tallahassee. Ballard also is a fundraiser and adviser to Crist's campaign.
Jennifer Liberto can be reached at liberto@sptimes.com.