1. Prescription Drug Advertising
Augustine SCREPEL

2. Summary Generalities Prescription Drug Advertising
Print Prescription Drug Advertising
Broadcast Prescription Drug Advertising
Infraction : How and what are the consequences ?
Conclusion

3. Generalities

4. Generalities Regulatory authorities Federal Trade Commission (FTC):
OTC
Food and Drug Administration (FDA)
(Section 502 (n) of the Federal Food, Drug and Cosmetic Act)
Prescription drugs (PD)
Biologicial products
Medical Devices (hearing aids, contact lenses…)

5. Office of Medical Product and Tobacco
Center for biologics evaluation & Research
Center for Drug Evaluation and Research (CDER)
Office of Medical Policy
Office of Prescription Drug & Promotion (OCDP)
Office of Medical policy Initiatives
Center for devices and radiological health
Center for tabacco Products
Inside the FDA, it’s the OCDP, who is a part

6. Generalities Legal Framework Federal Food, Drug and Cosmetic Act
Code of Federal Regulations
21 CFR Part 2012: Prescription drug advertising
21 CFR 312.7: Preapproval Pomotion
21 CFR : Accerated Approval
FDA’s Guidances

7. Generalities For Federal Laws, Advertisement ≠ Promotional Labeling
Promotional Labeling : « accompany » the drug even it’s not physically attached to it.
Brochures and booklets
Mailed materials (including letters to patients)
Magnets and other giveaway that show drug’s name
Advertisement (Ads): appears in
Periodics (journals, magazines and newspapers)
Broadcast media (TV, radio)
For Federal Laxs,advettisement and

8. Prescription Drug Advertising

9. Prescription Drug Advertising
Status and regulations are the same regardless of the audience targeted by the Prescription Drug Advertisement.
Direct-to-consumer (DTC) ads : advertising that is aimed toward a general audience rather than healthcare providers (doctors, nurses and pharmacists).
All advertising must contain:
The name of the drug (Brand and Generic)
At least one FDA-approved use
All the risks of using the drug

10. Prescription Drug Advertising
FDA does not pre-approve or « clear » a prescription drug advertising prior its dissemination (except for example, in case of accelerated approval).
Advertising are allowed for all prescription drugs even the ones that can cause severe injury, addiction or withdrawal effects.
But companies can not use reminder ads for drugs with black box warnings.

11. Prescription Drug Advertising
Example of Reminder Ad

12. Print Advertising Must contain a Brief Summary of information
relating to sideffects, contraindications and effectiveness.
Based on the drug’s prescribing information
Generally include :
Who should not take the drug
When the drug should not be taken
Possible serious side effects + what can be done to lower the chance to having them (if known)
Frequently Occuring, but not seriously SE

13. Lipitor Advertisement (2011)

14. Broadcast Advertising
Brief Summary or Adequate Provision to find the drug’s Prescribing Information
= Alternative way to provide risk information :
A healthcare provider
A Toll-Free telephone number
A web site adress
Major statement :
it refers to the presentation of the drug’s most important risks.
Must be presented in a clear, conspicuous and neutral manner
Must be in the audio or audio/video

15. What are not required : Cost
If there is a generic version of the drug.
If there is a similar drug with fewer or different risks that can treat the condition.
How many people have the condition the drug can treat
The mechanism of action

16. Infraction : How and What are the consequences ?
Augustine SCREPEL

17. Situations when ads violate the law
State or imply the drug can treat a condition non-approved by the FDA
Overstate the drug benefits
Leave out a brief summary
Fail to attach the drug’s Prescribing Information
Appear to be a reminder ad but make claim about the drug
Appear to be a reminder ad but it’s about a drug with a boxed warning
Etc…

18. Consequences
FDA can :
send a letter to the drug company with the explanations and ask to remove the ad.
FDA can ask to fix the misimpression made by the violative ad.
Enforcement letters are posted on the website of the FDA Warning Letters
Enforcement actions are possible

19. Conclusion
Augustine SCREPEL

20. Conclusion US Regulations ≠ UE regulations
DTC ads are often challenged
Not specific regulations for Internet Advertising/Promotion

21. Thank You