Generic thyroid drug clears boards
By Christine Jordan Sexton
10/14/2009 © Health News Florida
The Florida Board of Pharmacy on Tuesday voted to make a common thyroid medicine more readily available to patients as a generic -- a decision that could eventually save consumers and the Medicaid program millions of dollars. Almost all other states have already taken this step.
Don’t expect changes in Florida anytime soon, though. Abbott Laboratories, which has fought to keep Synthroid on a state list of drugs that can't easily be switched for generics, can still challenge the rule. It is not uncommon for rule challenges to last for years.
If the rule is not challenged, it could become effective by early 2010, said Board of Pharmacy attorney Diane Guillemette. Abbott spokeswoman Raquel Powers said the company will “evaluate our options moving forward.”
The change in the rule on levothyroxine sodium -- the chemical name for Synthroid -- had to be approved by both the Board of Medicine and Board of Pharmacy before being published. The medical board voted 9 to 4 for the change earlier this month; the vote by the pharmacy board was unanimous.
Removing the drug from the state list, called the "negative drug formulary," would mean that pharmacists would be able to substitute less-expensive generic versions that have been approved by the Food and Drug Administration as being safe, effective and "bioequivalent," meaning they have the same action in the body. Mylan Pharmaceuticals, which makes A-rated generic versions of levothyroxine sodium, was the originator of the effort to get the drug stricken from the formulary.
The rule change, when it goes into effect, doesn’t ban access to Synthroid, Pharmacy Board member Cynthia Griffin stressed. If doctors write on the prescription that the brand name is "medically necessary," pharmacists must honor that. Thyroid patients need "to have that conversation with their physicians,” the Jacksonville pharmacist said.
Ironically, the wives of both the chair and vice chair of the pharmacy board take Synthroid, the board officials said. Both women refuse to take anything other than the brand name, they said.
“She will not take (the generics) because there is too much fluctuation. Not in the results she receives, but in the product itself, the looks of the product,” said Board of Pharmacy Vice Chairman Jim Powers, a community pharmacist in Tallahassee. “That’s the way it’s going to be. I am a pharmacist and I look at it differently.”
Ron Salem, chairman of the board, said his wife directs the doctor to write medically necessary on the prescription. Her refusal to use anything but Synthroid means he pays higher monthly costs to fill the prescription.
“I don’t necessarily agree with her,” Salem said. “I learn to pick my fights over the last couple of years and that’s not one of them. I pay an extra $20 a month or so and I’m willing to do that.”
Board of Pharmacy members Steve Melvin and Michele Weizer both work as hospital pharmacists. Before voting both of them stressed that there have been no adverse medical incidents at their facilities, which routinely use generic versions of levothyroxine sodium.
--Carol Gentry, Editor, contributed to this article. Christine Jordan Sexton is co-founder of TallahasseeReporters.com.