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Pulling the plug - PHRMA Guiding Principles

 


1. These principles are premised on the recognition that DTC advertising of prescription drugs can benefit the public health by increasing awareness about diseases, educating patients about treatment options, motivating patients to contact their physicians and engage in a dialogue about health concerns, increasing the likelihood that patients will receive appropriate care for conditions that are frequently under diagnosed and under treated, and encouraging compliance with prescription drug treatment regimens.

2. In accordance with FDA regulations, all DTC information should be accurate and not misleading, should make claims only when supported by substantial evidence, should reflect balance between risks and benefits, and be consistent with FDA approved labelling.

3. DTC television and print advertising, which is designed to market a prescription drug, should also be designed to responsibly educate the consumer about that medicine and, where appropriate, the condition for which it may be prescribed.

4. DTC television and print advertising of prescription drugs should clearly indicate that the medicine is a prescription drug to distinguish such advertising from other advertising for non-prescription products.

5. DTC television and print advertising should foster responsible communications between patients and healthcare professionals to help patients achieve better health and more complete appreciation of both the health benefits and the known risks associated with the medicine being advertised.

6. Firms should spend an appropriate amount of time to educate health professionals about the new medicine or a new therapeutic indication before starting the first DTC advertising campaign. In determining what constitutes an appropriate time, firms should take into account the relative importance of informing patients of the availability of a new medicine, the complexity of the risk–benefit profile of that new medicine and healthcare professionals’ knowledge of the condition being treated. Companies should continue to educate healthcare professionals as additional valid information about the new medicine is obtained from all reliable sources.

7. Working with the FDA, companies should continue to responsibly alter or discontinue a DTC advertising campaign should new and reliable information indicate a serious previously unknown safety risk.

8. Companies should submit all new DTC television advertisements to the FDA before releasing these advertisements for broadcast.

9. DTC television and print advertising should include information about the availability of other options such as diet and lifestyle changes where appropriate for the advertised condition.

10. DTC television advertising that identifies a product by name should clearly state the health conditions for which it is approved and the major risks associated with the medicine being advertised.

11. DTC television and print advertising should be designed to achieve a balanced presentation of both the benefits and risks associated with the advertised prescription medicine. Specifically, risks and safety information in DTC television advertising should be presented in clear, understandable language, without distraction from the content, and in a manner that supports the responsible dialogue between patients and healthcare professionals.

12. All DTC advertising should respect the seriousness of the health conditions and the medicine being advertised.

13. In terms of content and placement, DTC television and print advertisements should be targeted to avoid audiences that are not age-appropriate for the messages involved.

14. Companies are encouraged to promote health and disease awareness as part of their DTC advertising.

15. Firms are encouraged to include information in all DTC ads, where feasible, about help for the uninsured and underinsured.



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2nd September 2008

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