ORAL CONTRACEPTIVE MAKERS MUST END UNPROVEN SUPERIORITY CLAIMS
ORAL CONTRACEPTIVE MAKERS MUST END UNPROVEN SUPERIORITY CLAIMS in product promotions, FDA said in a June 19 letter. The letter was sent to 12 companies that have approved NDAs or ANDAs for oral contraceptives. "The agency is concerned about several themes that have appeared in recent promotional materials for oral contraceptive products," the letter says. "These themes appear to be attempts to establish differences between the various products." The letter, written jointly by the Divisions of Drug Marketing, Advertising, and Communications and Metabolism and Endocrine Drug Products, points out that "these attempts to differentiate products within this class are misleading because they rely on claims that are not, as yet, proven to be of actual clinical relevance to the safety and effectiveness of the various products." FDA listed examples of the more common claims used to differentiate oral contraceptives, including "claims of a low incidence of androgenic effects and/or lipid effects because of a particular progestational agent or dose of that agent; claims of a lower incidence of common oral contraceptive side effects; claims of a low incidence of breakthrough bleeding; and claims that 'phasing' of the product (differences in the amount of hormonal content) minimizes total hormonal dose and that the slight differences in this phasing is of clinical importance." The agency stated that "all manufacturers are requested to cease using these or similar themes in their promotion of oral contraceptive products." FDA added: "To date, there have been no data submitted to the agency which demonstrate that the differences being cited in the promotion of low dose oral contraceptives indeed exist and, if so, are clinically relevant." FDA pointed out that the letter should be viewed as an "informal guidance regarding acceptable promotion for these products at this time." If "at some time in the future such differentiations are demonstrated via adequate and well-controlled studies to be clinically meaningful, promotion of the specific product on that basis would be allowed." Although the agency said that the letter was prompted by claims made in professional promotions, such as detail pieces, journal ads, or meeting exhibits, the guidance is also applicable to direct-to-consumer advertising of these products. FDA requested that companies submit "any proposed direct-to-consumer advertisement" to the ad division for clearance. FDA took the opportunity to point out that the agency is developing a general policy for direct-to-consumer advertising of prescription drugs. "In the interim, the involved Divisions have considered the advertising of oral contraceptives directly to the consumer and have determined that the appropriate promotion to consumers should be that of non-product specific advertisements which might also encourage women to discuss their contraceptive choices with a health care provider (e.g. 'help-seeking' advertisements)."
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