Drug & Device News

In an effort to advance President Obama's goal of promoting greater governmental transparency, the U.S. Food and Drug Administration (FDA) recently launched a new performance management system that will make it easier for the public to monitor the inner workings of the agency. The system, known as FDA-TRACK, will allow the public to observe some of the goings-on in more than 100 FDA program offices, through data that is gathered monthly. “FDA-TRACK will bring the operations of this historically opaque Agency into the daylight and help us be even more responsive as we work to protect the public health,” said FDA Commissioner Margaret Hamburg, M.D., in a statement. The system monitors performance indicators in four categories: 1) Common Measures ' Agency-wide measures applicable to each of the more than 100 program offices; 2) Key Center Director Measures ' Center-specific measures that are applicable to each Center and are central to the Center's priorities and strategic goals; 3) Program Measures ' Program office-specific measures that are applicable to the office; and 4) Key Projects ' Performance for Key Projects is measured through achievement of the stated milestones within the project's plan. For information on how to locate specific data, see the FDA release at: http://www.fda.gov/AboutFDA/Transparency/track/default.htm.

Forest Pharmaceuticals Inc. has pleaded guilty to selling an earlier, unapproved, version of its now-compliant drug Levothroid (levothyroxine sodium tablets, USP). The company was selling levothyroxine sodium tablets for the treatment of hypothyroidism when the FDA announced in 1997 that it would let manufacturers of these products continue to sell them so long as they obtained FDA approval. Because levothyroxine was considered a medically necessary product, the FDA created a permissive schedule that would allow manufacturers to gradually phase out distribution of unapproved levothyroxine sodium drug products; such sales were to cease after August 2003 if the products had not received approval by then. Forest Pharmaceuticals did not obtain approval for its product in a timely manner, however, and rather than gradually decreasing its sales over the years, it increased them. A warning letter to the manufacturer was ignored, according to the FDA. In a release announcing the guilty plea, Deborah M. Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said, “These charges should serve as a warning to industry that the FDA takes seriously its role to protect the public from unapproved drugs. Any company that operates in violation of the FDCA and ignores FDA's warnings should be aware that a criminal action could follow.” This action does not affect the drug product currently being marketed by Forest Pharmaceuticals known as Levothroid, as it does have an approved New Drug Application and is compliant with FDA regulations.