Rx Labeling Final Rule Largely In Line With Draft Version
This article was originally published in The Pink Sheet Daily
Executive Summary
New labeling format will apply initially to recently approved drugs and products receiving approval for new uses, agency says.
|
FDA's final physician labeling rule remains largely unchanged from the draft version released five years ago. Among other stipulations, the long-awaited final rule, released Jan. 18, requires a "Highlights" section be placed at the top of labeling and that labels note the date of initial product approval. The Highlights section, described by FDA as "a summary outlining the most important information about a product, prominently displayed at the top of the page," is the most significant departure from the current labeling format. The Highlights section will be approximately one-half page in length and will include summaries of information included in the Boxed Warnings, Indications & Usage, Dosage & Administration, Warnings & Precautions, Adverse Reactions, and Drug-Drug Interactions sections, the agency said. The summaries will also direct users to the corresponding sections in the full labeling. A list of all substantive changes made to labeling within the last year will also be included in the Highlights section. In comments on the draft rule, manufacturers expressed concern that a Highlights section could create inconsistency between labeling for products within a single drug class and on a product-by-product basis. FDA has indicated that the addition of the Highlights section could force manufacturers to place drug warnings at the beginning of direct-to-consumer advertisements (1 (Also see "New Labeling Rule Will Require Rx Warnings To Appear At Beginning Of DTC Ads" - Pink Sheet, 15 Nov, 2004.)). The new labeling format will include a Table of Contents designed to address the complexity of labeling, FDA said: "Physicians will now be able to find critical information more quickly, through a new Table of Contents that refers readers to detailed information located in the label." The revised labeling format will also provide users with "a toll-free number and Internet reporting information for suspected adverse events to encourage more widespread reporting of suspected side effects." Labeling will further include a Patient Counseling Information section designed to help physicians explain to patients the proper use, limitations and potential risks associated with the product. The new labeling format requirements apply to all products approved in the last five years and "will be phased in gradually," FDA said. Initially, the changes will only "apply to newly and recently approved prescription drugs and drugs that receive approval for new uses," the agency added. The agency said it is "encouraging" sponsors of older products to comply with the new labeling requirements on a voluntary basis. FDA released the draft rule in December 2000; between releasing the draft rule and publication of the final rule, the agency held focus groups and public meetings and reviewed physician surveys and written comments on the draft rule. Release of the final rule was also delayed due to an extended review by the White House Office of Management & Budget (2 (Also see "Physician Labeling Rule Review Extended" - Pink Sheet, 8 Jul, 2005.)). -Andrew Kasper |