Congress Opposes FDA’s Proposed Rule on Labeling Changes

ePT--the Electronic Newsletter of Pharmaceutical Technology

Members of Congress have strongly urged the US Food and Drug Administration to reconsider its proposed rule to amend regulations permitting companies to promptly update their drug and device labels with new safety information.

Washington, DC (Jan. 23)-Members of Congress strongly urged the US Food and Drug Administration to reconsider its proposed rule to amend regulations permitting companies to promptly update their drug and device labels with new safety information. The proposed rule, “Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices, was published in the Federal Register on Jan. 16 and is open for comment until March 17, 2008.

manufacturers are currently allowed to change their labels through changes-being-effected (CBE) supplements, to add or strengthen a contraindication, warning, precaution, or adverse reaction without approval from FDA. As stated in the proposed rule, the amendments to the current provisions would “…reaffirm that a CBE supplement is appropriate to amend the labeling for an approved product only to reflect newly acquired information and … clarify that a CBE supplement may be used to add or strengthen a contraindication, warning, precaution, or adverse reaction only if there is sufficient evidence of a causal association with the drug, biologic, or medical device.”

Legislators wrote a letter to FDA Commissioner Andrew C. von Eschenbach, suggesting that the proposed rules “will serve only to deprive American consumers of critically important and timely information about the safety of their drugs and medical devices” while “protecting the drug and device industry from liability for marketing dangerous products.” The lawmakers notes that companies are facing an increased number of liability lawsuits and that FDA is operating under limited resources. The letter was signed by Representatives H.A. Waxman, J.D. Dingell, E.J. Markey, F. Pallone, Jr., and R.L. DeLauro, and Senators C.J. Dodd, P.J. Leahy and E.M Kennedy.

In addition, because the letter reports that FDA has “failed to provide any evidence or rationale for its proposal,” it urges the agency to provide the following information no later than Feb. 13:

  • The number of CBE supplements the agency has received each year from 1982 to the present

  • A description of any cases in which a manufacturer used the CBE procedure to add or strengthen a contraindication, warning, precaution, or adverse reaction in a manner that harmed the public health, including the dates of such cases, and why the agency believes that modifying the regulations has become a high public health priority

  • Any documents demonstrating concern on the part of the Center for Drug Evaluation and Research or the Center for Devices and Radiological Health about misuse of the CBE regulations or about public health risks arising from their current language

  • The number of FTEs used to issue this proposed rule and a timeline for when work began on this effort.