Drug & Device News

FDA's New System Aims to Increase Transparency

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.

In September, the FDA made the unusual move of restricting the prescription of the diabetes drug Avandia (rosiglitazone) to new patients, rather than leaving access to it as-is or pulling it from the market completely. The new restriction was placed on sales of the GlaxoSmithKline (GSK) drug because of concerns that it elevates the risks of heart attack and stroke, but concerns that certain patients can achieve control over their disease only when using Avandia prevented a total ban. “Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug,” said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. In order to comply with the FDA's restrictions, GSK will have to develop a restricted access program that permits new prescriptions only to those patients who are unable to take Actos (pioglitazone), the only other drug in the same class as Avandia. Doctors who wish to put their patients on Avandia will have to have them sign acknowledgements that they have been made aware of the risks associated with its use, and the doctors themselves will have to document and attest to their patients' eligibility under the new rules. The FDA expects the new limitations on prescriptions to significantly decrease the number of Avandia users.

FDA's New System Aims to Increase Transparency

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.

In September, the FDA made the unusual move of restricting the prescription of the diabetes drug Avandia (rosiglitazone) to new patients, rather than leaving access to it as-is or pulling it from the market completely. The new restriction was placed on sales of the GlaxoSmithKline (GSK) drug because of concerns that it elevates the risks of heart attack and stroke, but concerns that certain patients can achieve control over their disease only when using Avandia prevented a total ban. “Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug,” said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. In order to comply with the FDA's restrictions, GSK will have to develop a restricted access program that permits new prescriptions only to those patients who are unable to take Actos (pioglitazone), the only other drug in the same class as Avandia. Doctors who wish to put their patients on Avandia will have to have them sign acknowledgements that they have been made aware of the risks associated with its use, and the doctors themselves will have to document and attest to their patients' eligibility under the new rules. The FDA expects the new limitations on prescriptions to significantly decrease the number of Avandia users.