OTC labeling
This article was originally published in The Rose Sheet
Executive Summary
Block Drug awaits FDA ruling on labeling exemption request for BC analgesic powder after Aug. 22 submission of information previously regarded confidential. Block initially requested an exemption in August 1999. According to the firm, FDA told Block it had ruled on the matter but would not file its decision in the docket unless the confidential information was either removed or opened to public record. "Consequently, in order to move the process forward and receive FDA's response...Block has decided to waive confidentiality," the company says. The petition, filed by Hyman, Phelps & McNamara (D.C.), suggests FDA's actions mark a change in attitude toward confidentiality. Agency statements on the issue have varied, ranging from an Aug. 9, 1999 letter to CTFA stating some exemption request sections may be made public to assurances at a November feedback meeting that handling of exemption requests would be in keeping with Freedom of Information Act standards. CTFA has encouraged FDA to allow certain information to remain confidential (1"The Rose Sheet" Dec. 20, 1999, p. 7)
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FDA mishandled its decision to deny Block Drug a small packaging exemption by assuming off-label information could not be easily read and interpreted by consumers, the Consumer Healthcare Product Association maintains in Oct. 3 comments to the agency.
Block Drug OTC Small Packaging Denial Mishandled By FDA, CHPA Says
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OTC labeling reg
Additional extensions beyond the May 16, 2002 compliance deadline may be necessary "to compensate for agency inaction on several important issues related to the OTC labeling rule," CHPA maintains. The association's Sept. 18 letter responds to FDA's decision to grant a one-year partial extension to the rule (1"The Rose Sheet" Feb. 14, p. 3). CHPA "welcomes the additional time," but says it "may not be enough due to a lack of clear direction in several areas," including issues related to small packages and convenience-size products, the agency's failure to release a final guidance on columns and a draft guidance on exemption petitions, and FDA's handling, "in at least one circumstance," of confidential information included in exemption petitions. Block Drug recently challenged FDA's approach to confidentiality during the agency's review and subsequent denial of a Block exemption request (2"The Rose Sheet" Sept. 11, In Brief)