A landmark law to protect consumers by requiring prescription drugs' origins to be tracked will be gutted if drug wholesalers get their way.
By Times editorial
Published May 17, 2006
When lobbyists for the pharmaceutical industry gather outside the Florida Senate chamber in the final hours of the session, there is reason to be concerned. When the House passes a bill with an amendment those lobbyists want in the last minutes before the legislative session adjourns at midnight, it raises even more eyebrows. Now that the dust has settled, those suspicions that the late-night maneuvering protects special interests rather than patients prove to be justified.
It turns out that the amendment tacked on to HB 371 guts a landmark 2003 state law that would require each prescription drug to travel from the manufacturer to the wholesaler to the retail pharmacy with "pedigree'' information detailing its source and its travels. Instead of being a trendsetter when the pedigree requirement kicked in July 1, Florida would take a step backward and cave in to the big drug wholesalers who don't want to spend the time or the money to track each drug to the corner store. Attorney General Charlie Crist, a strong advocate of the 2003 law and the pedigree requirement, asked Gov. Jeb Bush Tuesday to veto the bill. The governor should follow the attorney general's advice.
At the federal and state level, the pharmaceutical industry has been engaging in delay tactics for years to avoid the systematic tracking of prescription drugs. Neither the federal nor state rules have been rigorously enforced, and the 2003 law was finally supposed to change that when the requirements became effective in 2006. But a three-year delay wasn't enough to satisfy the industry. First the lobbyists tried to put off the effective date by at least another year. When that didn't work, they complained about the cost and the technology as they pushed a bill this session to eviscerate the law. And when that didn't work and the bill got stuck in committee, they amended an unrelated bill in the final hours of the legislative session. That was the last bill the House passed just before the clock struck midnight.
Floridians who believe they are protected from counterfeit or mislabeled drugs because they get their prescriptions filled at brand-name stores or by their familiar corner pharmacists are naive. A 2003 report by a statewide grand jury details how drug wholesalers acquired drugs not just from the manufacturers but from other wholesalers or less reputable middlemen. By the time those drugs reach the pharmacy, it is often next to impossible to trace them back to their original source. The statewide grand jury investigated racketeering and counterfeiting in the drug industry, and those revelations led to the landmark 2003 law.
Now those consumer protections are in jeopardy unless Bush vetoes the bill. Instead of requiring documentation such as the origin of the drug and its lot number to travel with the drug, HB 371 would allow the big wholesaler merely to make a sworn statement that it received the drug from the manufacturer and distributed it to a chain pharmacy. It would supply some detailed pedigree information to the state upon request.
That's not good enough. Crist says the bill's wording "blows a hole'' in the 2003 law and that drugs still could be moved multiple times without adequate tracing. Stephanie Feldman Aleong, an assistant professor of law at Nova Southeastern University who prosecuted drug fraud cases for the statewide prosecutor, says the changes would make it more difficult to prosecute drug counterfeiters.
Bush has a choice to make. Does he want to side with the big drug wholesalers and their lobbyists, or does he want to see the 2003 drug pedigree legislation he praised when he signed it into law take effect and give Floridians some peace of mind that their prescriptions are being filled with safe, properly labeled drugs?
