Direct to Consumer (DTC) Advertising Patient Dispensing and Compliance Review Advertising as used herein is defined as: all promotional and advertising activities that directly or indirectly market, sell or support the sales and use of The Blaine Labs (BL) products, or that contribute to the sales of Blaine Labs products. Advertisement as used herein means all advertising material, printed or electronic, that directly or indirectly promotes, markets, sells or supports the sales and or use of Blaine Labs (BL) products, or that contribute to the sales of BL products. This includes all printed and broadcast media viewable by the general public, including, newspaper, radio, television, billboard, magazine, internet, patient hand-outs, in-office videos, direct mail, and all other doctor or practice promotional efforts. All Advertisements must be submitted to BL for a Compliance Review BEFORE publication and publication may occur only with prior written approval by BL When conducting a Compliance Review, BL will examine whether an Advertisement meets and conforms to the following criteria, with particular focus on whether it satisfies the following core criteria and FDA labeling requirements. In so doing, BL will consider both the general spirit as well as the specific communication points of the Advertisement. The principles described set forth here provide some specific tenets of responsible DTC Advertising practices to which health providers must adhere. The criteria are intended to provide greater specificity, and therefore certainty, regarding that content which is patently allowed or prohibited. The procedure for requesting a Compliance Review follows later in this document. PRINCIPLES To be consistent with the FDA-compliant labeling requirements. (See BL Physician Advisory To conform with BL’s Doctor Only distribution and Office Dispensed program. To comply with BL refund program requirements and encourage a doctor consultation before purchase and use of BL products. To make the general public aware of the medical offices where BL products are available for purchase. CRITERIA FOR ADVERTISING/PROMOTION
1. All Advertisements must be submitted to BL for a Compliance Review BEFORE publication and publication may occur only with prior written approval by BL.
2. An Advertisement may contain a photo of a BL Product. BL will supply product photo if requested.
3. An Advertisement shall not indicate any off label treatment or use.
4. An Advertisement shall not contain or list BL’s (800) telephone number.
5. No Advertisement shall offer the sale of a BL Product(s) online, or in any venue other than at the doctor’s office or medical clinic. INTERNET SALES ARE STRICTLY PROHIBITED.
6. Advertisements must not be deceptive or misleading. All claims of fact must be fully supported and meaningful in terms of performance or any other benefit. Tetra reserves the right to request additional information as needed to support claims.
7. Advertisements must comply with all FDA and FTC policies, rules, regulations or recommendations.
8. By submitting Advertising copy, advertisers certify that such copy is in accord with all applicable state laws and regulations. In conducting a Compliance Review, BL is relying on the advertiser’s certification that the Advertisement complies with such laws and regulations.
9. The Advertisement may cite, in footnotes, references from medical and other scientific literature provided the reference is truthful and is a fair and accurate representation of the body of literature supporting the claim made.
10. Comparative advertising claims for competing products must be substantiated adequately. Unwarranted disparagements or unfair comparisons of a competitor’s products or services will not be allowed.
11. The advertiser should be clearly identified in the Advertisement with a minimum of contact name, address and listing of phone number or email address is encouraged.
12. Advertising that simulates editorial content must be clearly identified as advertising. The word “advertisement” must be displayed prominently.
13. Advertisements must not quote the names, statements or writings of any BL employee or representative, as well as any individual, public official, government agency, testing group or other organization without their express written consent. A copy of which shall accompany the application for Compliance Review. ADVERTISER/DISPENSER ACKNOWLEDGEMENT AND AGREEMENT By publishing an Advertisement, with or without a Compliance Review, we agree to be bound by these terms and conditions. We agree that if we publish any Advertising found to be contrary to these terms and conditions that will result in immediate suspension of all sales of BL products to us by BL. We agree that any publication, or threatened publication, of an Advertisement that does not fully comply with these terms and conditions, is likely to cause irreparable harm to BL for which money damages may not be a sufficient remedy. We therefore further agree that BL shall be entitled to receive injunctive or other equitable relief, with or without advance notice to us, to remedy or prevent any publication of an Advertisement that does not in every respect comply with these terms and conditions. We agree that if we make, or attempt to make, any sales of BL products over the internet, BL shall be entitled to injunctive relief enjoining such sales. If BL prevails in a legal proceeding against us for a violation of these terms and conditions, we agree to pay all of BL’s costs and actual attorney fees incurred in connection with such action. An action for injunctive relief is not the exclusive remedy for any breach or threatened breach of the terms and conditions, but is in addition to all other rights and remedies available at law or in equity to BL. We further agree to indemnify and hold BL harmless from and against all claims, including administrative enforcement actions, losses and expense, including legal fees, that arise out of or relate in any way to our publication of an Advertisement that does not fully comply with these terms and conditions which Advertisement we have not approved for publication according to these terms and conditions. Email to: m.villalta@blainelabs.com With the following:
1. a full size copy of the Advertisement (or a full length copy of the video or audio Advertisement)
2. a description of the intended audience explaining how the Advertisement will be used. A PDF of these terms and conditions is available in the Physicians Portal under the heading “Resources”