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Fortune at stake in thyroid drug fight

By Carol Gentry
10/13/2009 © Health News Florida

Are Florida consumers paying millions of dollars a year more than they need to for a common thyroid drug because of an out-of-date regulation?

Decisions by the Food and Drug Administration and by 48 other states would indicate the answer is yes. But Abbott Laboratories, maker of Synthroid, says no, and it’s fighting to retain the market advantage it has under Florida law.

Florida consumers as well as Medicaid are affected by the fight between Abbott and generic drugmakers, led by Mylan Pharmaceuticals. Mylan estimates the waste in Florida at $22 million, based on its own products priced as low as $4 at Wal-Mart and Synthroid’s price as much as 10 times that. Abbott counters that the difference in price for similar dosages, depending on the pharmacy, can be as low as $10 a month.

But consumer advocates say even $10 a month adds up, given that patients must take the supplement for the rest of their lives. As Board of Medicine member Lisa Tucker put it, “People are having to choose, do I eat or do I take my medicine?”

In hearings and courts, the fight's been going on ever since the FDA decided Mylan’s products were “bioequivalent” – acted the same way in the body – as Synthroid, in 2004. In most states, the hurdles to generics melted away quickly, but not in Florida.

With millions of dollars in profits at stake, Abbott has had incentive to challenge the move to generics. It has been helped by a lack of clarity in the state law that governs the formulary.

Repeated efforts to allow generic substitution for levothyroxine sodium – the chemical name for Synthroid –have been thwarted. But another effort is under way. The Board of Medicine voted 9 to 4 to end the preference for Synthroid earlier this month; today the Board of Pharmacy is debating the issue in Tallahassee.

Abbott and several doctors who specialize in thyroid treatment say that allowing generic substitution for Synthroid would place very vulnerable patients at risk, especially those who have lost their thyroid glands to cancer. If hormone levels get too high, their cancer can return, doctors say; if it gets too low, they feel bad.

But medical board members who slogged through 573 pages of testimony said that neither the doctors nor Abbott offered persuasive scientific evidence to counter the FDA’s findings that the generic behaves the same way that Synthroid does in the body, that it’s “bioequivalent.”

“I appreciate that your company wants to keep its hold on the patients that you prescribe to, but I don’t see how that’s in the best interest of the citizens of the state of Florida,” said Jason Rosenberg, a Gainesville plastic surgeon.

The Florida regulation that gives Synthroid preference is the “negative drug formulary,” the list of prescription drugs for which pharmacists may not substitute a generic equivalent without the doctor’s permission. Levothyroxine has been on the state’s negative drug formulary since 1984.

Most states permit substitution for brand names to begin as soon as the FDA affirms that a generic drug is bioequivalent, safe and effective. The agency releases its guidelines in the so-called “Orange Book,” which is periodically updated.

After the FDA gave its top rating -- an A -- to Mylan's products and several others five years ago, it updated the Orange Book. But Florida laws don't take updates into consideration; therein lies the present stand-off.

When Mylan challenged the Florida restrictions in 2007 before Administrative Law Judge Susan B. Harrell, she heard testimony from Abbott that the generics weren’t safe substitutions, but she said the FDA’s decisions overruled it. She agreed with Mylan that levothyroxine synthroid should be taken off the negative drug formulary, and since neither the medical board nor the pharmacy board appealed, her decision went into effect in January 2008.

The State Board of Pharmacy told pharmacists throughout the state that they could begin substituting the generic equivalents for Synthroid. For 15 months, they did.

Generics, which had only 19 percent of the market in Florida before her ruling, soon accounted for 66 percent of sales, according to data from industry sources presented at hearings. In Florida, generic thyroid drugs nearly matched the 69-percent national market share.

Some physicians, particularly endocrinologists, were alarmed. They felt the FDA tests weren’t precise enough to pick up variations in hormone levels that could be meaningful. While they could ensure their patients received the brand name by writing that Synthroid was “medically necessary” on the original prescription, they feared it would get lost down the line as primary-care doctors renewed it.

Victor Roberts, who sits on the board of the American Association of Clinical Endocrinologists and teaches at University of Central Florida, said low thyroid isn’t like heart disease, diabetes and other illnesses that can be controlled by generic drugs.

“My physician gives me a generic antibiotic; I have no problem with that,” he said at a hearing in Orlando Sept. 26. “But if I took thyroid medicine, I would insist on brand thyroid medicine. I would not accept any generics.”

Abbott didn’t sit by idly watching its market share plummet after pharmacists were allowed to start substitutions. Its attorneys appealed Harrell’s decision to the First District Court in Tallahassee. In June, it was overturned. The court said the law that governed the matter took effect in 2001, and the Orange Book in effect at that time listed no approved generics.

So pharmacists received a second round of orders from Tallahassee, this time to stop substituting generics for Synthroid unless doctors specifically wrote the prescription for the generic. A lot of patients got switched back to the higher-priced drug; pharmacists besieged doctors with calls requesting approval for generics.

So that is where things stand. Even if the Pharmacy Board agrees with the Medical Board today, as it has in the past, it is unclear how long it will take for the rule to be rewritten. Abbott could again challenge it. 

--Carol Gentry, Editor,  can be reached at 727-410-3266 or by e-mail.