Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

ORAL CONTRACEPTIVE MAKERS MUST END UNPROVEN SUPERIORITY CLAIMS

Executive Summary

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)."
Advertisement
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS019357

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel