August, 2000 --- The recent announcement by the Food and Drug Administration that they've given the first approval to a New Drug Application (NDA) for a levothyroxine drug - Unithroid - raises an important question for thyroid patients who are currently taking one of the other brands of levothyroxine. Should you switch from another brand of levothyroxine to the newly-approved Unithroid brand?
Ron Steinlauf, Vice President of Long Island, New York-based Jerome Stevens Pharmaceuticals, the manufacturer of Unithroid, thinks you should. In an interview with Mary Shomon the last week of August, 2000, Steinlauf has shared some of his thoughts about Unithroid, the approvals process, and why patients may want to consider asking their doctors about switching over to this drug.
Unithroid is a new name on the thyroid drug market, but it's not a brand new drug. According to Steinlauf, Unithroid is the new brand name selected by the company, and approved by the FDA, for Thyrox, the levothyroxine product that Jerome Stevens has been manufacturing for a decade. Thyrox has been sold under its relatively unknown brandname, and Thyrox has also been distributed as a generic thyroid supplement.
The approval of Unithroid is the latest development in a three-year saga that began back in 1997, when the FDA declared that no levothyroxine products were able to demonstrate consistent potency and stability, and, thus, "no currently marketed orally administered levothyroxine sodium product is generally recognized as safe and effective." The FDA could not remove these thyroid drugs from the market, as they are considered medically necessary, essential for millions of people. Therefore, the FDA ruled that while the drugs could continue to be sold, manufacturers would now need to file new drug applications (NDAs) for levothyroxine, an approvals process that these drugs had never been subjected to, as they had been grandfathered in under for sale under regulations covering natural thyroid drugs more than half a century ago.
The 1997 ruling stated that after August of 2000, any levothyroxine drug that had not been approved through the NDA process (or found to be exempt from that process) could not be legally marketed and sold. Basically, any drug that did not successfully go through the NDA process would be illegal to sell. The 1997 notice also stated that any manufacturer who contended that their product was not subject to the NDA process would need to file a petition.
This set the stage for a competitive struggle as manufacturers strove to be the first approved levothyroxine drug. Initially, it appeared as if Synthroid, the second highest-selling drug in the U.S. in 1999, responsible for 85% of all the levothyroxine sold in America, would be first across the finish line, one way or the other.
In December of 1997, Knoll Pharmaceuticals, manufacturer of Synthroid, claiming that its product was not a new drug, and therefore not subject to this regulation, and was generally recognized as safe and effective (GRAS/E). In a letter from Dennis Baker, Associate Commissioner for Regulatory Affairs at FDA to Knoll Pharmaceuticals, Baker writes:
"it is the FDA's position that a manufacturer who markets an unapproved drug on the basis that it believes it is exempt from the new drug provisions of the Act (as Knoll has with Synthroid) must be ready to defend that claim at any time. Knoll has marketed Synthroid without an approved application for more than 40 years and is expected to have the information to defend its GRAS/E status already in its possession.)"