Drug Marketing Practices Flashcards
Which agencies are in charge or regulating Drug advertising and Promotion?
FDA regulates the advertising
Federal Trade Comission regulates OTC advertising
FDA and Federal Trade Comission given authority based on which amendment?
First amendment of free speech, but balance of public safety
What are the advertising requirements?
Must not be misleading, Government interest must be substancial, the restriction of speech can not be more then what is necessary, the regulation must be fdirectly pertantent to the government interest
What is the Lanham Trademark Act?
prohibits false description and representation of the substance
allows private cause of action to recover damages from product
what are the five items required in Manufacture Drug advertising to professionals?
Drug name must be stated, Formula of all ingredients, breif summary of major die effects, contraindications, and effectiveness and can not be misbranded
What types of advertising are included in the regulations to professionals from manufacturers?
ads in journals, broadcast media, periodicals, telephone communications
not pens, notepads, landyards ect
What are some charactoristics of an Educational symposium for a drug?
funded by a third party, pharma company dosn’t control the content, no promotional activities take place
What are some charactoristics of Promotional symposiums?
Directly funded by pharma company, labeling and advertising restrictions, off label uses not discussed, fair balance
How are journal Advertisings regulated?
By FDA, assess accuracy and truthfulness, corrective actions and remedial advertising
What is the Bad Ad Program?
gave healthcare professionals a place to report misleading promotions
In manufacturer to consumer advertising what is required?
no regualtions so FDCA applies, adequate provisions from studies required, in print advertising key risk information can be displayed in laymanes terms, preview of ads required
What are considered adequate provisions?
applies to broadcast media, only need to include major risks, adequate provisions of the dissemination of the labeling
Under FADAMA manufacters can advertise for what?
Off label uses for their product
Who regulates the ads the are deceptive|?
Federal Trade Comission, determine if they are deceptive to general public, only if they could mislead a reasonable customer, authority to require recorrective action
