Off-Label DTC Advertising Survey Results

R E S U L T S F R O M A S U R V E Y O F P H A R M A M A R K E T I N G N E W S R E A D E R S & T W I T T E R F O L L O W E R S O F P H A R M A G U Y

OFF-LABEL DTC ADVERTISING

2016. Pharma Marketing Network. All rights reserved.

Off-Label DTC Survey

FDA NOTICE HINTS AT OFF-LABEL DTC COMMUNICATIONS BY PHARMA

“To what extent is it appropriate for firms to communicate information about unapproved uses of their approved/cleared medical products to patient and consumer audiences?”

“What disclosures and additional information would be needed to help ensure that a communication to lay audiences is truthful and non-misleading, given consumers’ lack of medical training and expertise in critically evaluating this type of information?”



RESPONDENT PROFILE

Affiliation N = 28

75% are very or somewhat supportive of drug industry

64% are U.S. citizens

Access up-to-date results here: http://bit.ly/offlabelDTCsurveyResults

http://bit.ly/offlabelDTCsurveyResults



SUMMARY OF RESULTS: GUIDELINES?

FDA should create non-legally binding GUIDELINES for off-label DTC promotions by pharma companies.



SUMMARY OF RESULTS: REGULATIONS?

FDA should create legally binding REGULATIONS for off-label DTC promotions by pharma companies.



SUMMARY OF RESULTS: NEITHER!

Under NO circumstances should FDA allow off-label drug promotion to patients or consumers.



SUMMARY OF RESULTS: THINK TANK INPUT

A Duke University think tank suggested that a new independent entity be created to review claims and recommend exactly what off-label

information drug and device makers should be allowed to share with doctors. Should such an independent entity do the same with regard to

off-label information shared with consumers?



SELECTED COMMENTS

“I work in communications for biotech and pharma companies, and I think that regardless of regulation, we have an ethical obligation to be

cautious in how we communicate directly to consumers about drugs and medical devices, both for the sake of patient safety, but also for

healthcare economic reasons. Our industry, which deals with situations where lives are hanging in the balance, would do well to always pause

and ask itself if what it does is ethical.” – Employed at ad agency; Very

supportive of drug industry

“Marketing of off-label drugs would be easy to abuse, and would become a disincentive to do well controlled and sufficiently powered

studies needed to protect the public.” – Consumer, consumer advocate, patient,

or other non-industry aligned member of the public; Very supportive of drug industry



ONE MORE COMMENT

“There's enough confusion with and panning of current legal DTC. There is just too much information being shared with each TV ad. There

appears to be a strong, growing movement from medical professionals to ban DTC. Adding an off-label element is 100% unnecessary. If

anything, laws should change that only allow the brand name, generic, and indication to be shared with consumers and direct to the product

website. If consumers are really doing their own (online) homework and relying on their research to help understand their or their loved ones

condition, then FDA should foster that by creating better DTC--less information sharing on TV. Force consumers to go to the product website and learn more. Let the consumer absorb the info at their own pace.” ” –

Legal/regulatory professional; Very supportive of drug industry



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