Prescription Drug Advertising

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Presentation transcript:

Prescription Drug Advertising Augustine SCREPEL

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

Generalities

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…)

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

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 314.550 : Accerated Approval FDA’s Guidances

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

Prescription Drug Advertising

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

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.

Prescription Drug Advertising Example of Reminder Ad

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

Lipitor Advertisement (2011)

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

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

Infraction : How and What are the consequences ? Augustine SCREPEL

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…

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

Conclusion Augustine SCREPEL

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

Thank You