BILL KACZOR
Associated Press Writer
TALLAHASSEE, Fla. (AP) — A Florida law banning the substitution of certain drugs must be followed even if a generic version gets federal approval, a state appellate court ruled Monday.
A three-judge panel of the 1st District Court of Appeal unanimously said it would be unconstitutional for the Legislature to give up its authority over generic swaps to the federal Food and Drug Administration.
The law lists the drugs for which generics cannot be substituted. It's up to the Legislature to make any changes in that list, the appellate court ruled.
State Sen. Durrell Peaden, a retired physician, agreed with the ruling but said he may ask for a study by the Legislature's watchdog agency to determine whether the list should be changed.
"The FDA has made mistakes before," Peaden said. "I don't think we should ever delegate that power to anybody."
The court sided with Abbott Laboratories, which appealed Administrative Law Judge Susan B. Harrell's decision to remove a thyroid drug, including its name-brand Synthroid, from the list.
"It upholds a fundamental right of patients to receive the medications that are prescribed and intended by their doctors," said Abbott spokesman Scott Stoffel in Chicago.
Abbott's drug is prescribed for patients whose thyroid glands don't make enough of a hormone that regulates energy and metabolism. Synthroid also is used to treat or prevent goiters — an enlargement of the thyroid gland — that can result from hormone imbalances, radiation treatment, cancer or surgery.
Harrell had ruled that a generic version made by Mylan Pharmaceuticals Inc. could be substituted because the FDA in 2007 had given it an A rating, which meant it was the therapeutic equivalent of Synthroid.
William E. Williams, a lawyer for Mylan, said his client hadn't decided whether to appeal to the Florida Supreme Court. He declined further comment because he had not yet read the opinion nor consulted with his client.
Harrell based her ruling on another provision of the law that removes a generic from the list if it gets an A rating in the FDA's "Orange Book."
District Judge William A. Van Nortwick wrote that Harrell should not have applied that provision to editions issued after the law was passed in 2001.
It's up to the Legislature to update the list each year based on revised versions of the Orange Book, though it isn't required to follow the FDA's guidance, Van Nortwick wrote.