Florida Court Ruling has implications for physician's prescribing practice

A Florida State administrative judge ordered that levothyroxine sodium be taken off of the negative formulary list which had previously protected brand name thyroid hormone prescriptions

As of January 26, 2008, A Florida State administrative judge ordered that levothyroxine sodium be taken off of the negative formulary list which had previously protected brand name thyroid hormone prescriptions. Now pharmacists have the ability to substitute generic levothyroxine sodium at their professional discretion without the consent of the physician or patient. To ensure that a name brand prescription or refill order is honored the prescriber must now specifically write “Medically Necessary” on written prescriptions, or similarly make this statement for verbal or electronic prescriptions. This is the practice already in place in much of the United States. Without this additional instruction the prescription may be substituted with one of four available generics.

The brand names removed from the negative formulary include: Levothroid, Levoxyl, Synthroid, and Unithroid. Click here to view the complete order.

Since 2004, the FDA has sanctioned the use of generic levothyroxine preparations as equivalent to specific branded preparations. Since that time the American Thyroid Association (ATA), along with the American Association of Clinical Endocrinologists (AACE), and The Endocrine Society (TES) have endorsed a joint statement expressing concern about the flawed methodology used to determine bioequivalence, and the potential harm it could bring to patients.


See related articles on Bioequivalence of Levothyroxine