Direct-to-Consumer Off-Label Drug Promotion Survey Results

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Results from two surveys: (1) an online survey hosted by Pharma Marketing News and primarily focused on pharma executive participants and (2) an inVibe voice-response survey of patients, patient advocates, and caregivers sponsored by Pharma Marketing News. Preliminary results from these surveys were presented at an FDA public hearing on 9 November 2016.

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  • Today I will present some preliminary results from two surveys regarding direct-to-consumer off-label drug promotion. One is an ONLINE survey primarily of drug industry professionals and the other is an inVibe telephone voice-response survey of patients, patient advocates, and caregivers. Both were sponsored by Pharma Marketing News.
  • In the Federal Register notice announcing this public hearing, FDA asked these two questions, which put the the thought in my head that the Agency may be considering issuing guidelines or new regulations regarding the off-label promotion of drugs to patients and consumers.

    Considering that the FDA has been in a First-Amendment tussle with drug industry advocates over the issue of off-label promotion, I posited that if drug companies have a constitutional right to promote off-label uses of drugs to healthcare professionals, it also has a right to promote the same directly to consumers. It is not too much of a stretch to believe that the drug industry will eventually do this if given guidance by the FDA.

    Recall that no one thought prescription drugs would be advertised on TV until the FDA issued guidance in 1997. That opened the floodgates to the ads we see today.
  • To date, the survey of drug industry professionals has collected responses and comments from 30 respondents, most of whom are supportive of the drug industry and are based in the U.S.
  • The survey asked four questions about possible FDA actions regarding off-label promotion to consumers. The first was regarding non-legally binding guidelines. The majority of respondents did not agree that FDA should issue such guidelines.
  • The second question focused on legally-binding regulations. This question was included in the survey because many pharmaceutical companies have pushed for new regulations regarding other issues such as social media promotion to consumers. As expected, most survey respondents favored this approach.
  • Obviously, another option is prohibit off-label drug promotion to consumers altogether. 60% of respondents agree that under no circumstances should FDA allow drug companies to promote drugs off-label to consumers or patients.
  • The final question has to do with third-party input to help the FDA decide how to parse what is and what is not appropriate off-label information that may be communicated to consumers. A Duke University think tank proposed this for promotion to HCPs. The response was mixed with slightly more respondents in favor of the idea than those opposed.
  • The survey also asked respondents to submit comments. I won’t dwell on these here except to show you a few selected comments. The sentiment is that the drug industry must be very careful if it is ever allowed to promote off-label to consumers.
  • Although the drug industry spends 70% of its DTC budget on TV advertising, there is much criticism of on-label TV drug ads from the general public, healthcare professionals and even regulatory professionals such as this respondent.
  • inVibe engages patients, physicians, and payors on their smartphones and collects responses via automated, voice-response surveys.
  • inVibe engages patients, physicians, and payors on their smartphones and collects responses via automated, voice-response surveys.

    The survey that inVibe conducted for Pharma Marketing News asked 51 patients, caregivers, and patient advocates “do you think the FDA should allow off-label promotion of drugs to consumers by drug companies as long as the promotions (magazine and TV ads) provide truthful information based on current science?”

    63% responded “Yes,” 35% said “No,” and 2% had no opinion.
  • The voice-response system also recorded comments from each respondent. You also can go to www.pharmamarketingsurveys.com to listen to these comments.
  • I will continue to collect more survey responses and submit the final results to the FDA before the docket closes in January. Follow me on Twitter for more information or go to www.pharmamarketingsurveys.com to take the survey. Thank you for listening.
  • Direct-to-Consumer Off-Label Drug Promotion Survey Results

    1. 1. P R E S E N TAT I O N M A D E AT F D A P U B L I C H E A R I N G , W E D N E S D AY, 9 N OV E M B E R 2 0 1 6 ( U P D AT E D V E RS I O N )
    2. 2. 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?”
    3. 3. 2016. Pharma Marketing Network. All rights reserved. Off-Label DTC Survey PMN SURVEY* RESPONDENT PROFILE Affiliation N = 30 77% are very or somewhat supportive of drug industry 63% are U.S. based *Online survey hosted by Pharma Marketing News Access up-to-date results here: http://bit.ly/offlabelDTCsurveyResults
    4. 4. 2016. Pharma Marketing Network. All rights reserved. Off-Label DTC Survey SUMMARY OF RESULTS: GUIDELINES? FDA should create non-legally binding GUIDELINES for off- label DTC promotions by pharma companies.
    5. 5. 2016. Pharma Marketing Network. All rights reserved. Off-Label DTC Survey SUMMARY OF RESULTS: REGULATIONS? FDA should create legally binding REGULATIONS for off- label DTC promotions by pharma companies.
    6. 6. 2016. Pharma Marketing Network. All rights reserved. Off-Label DTC Survey SUMMARY OF RESULTS: NEITHER! Under NO circumstances should FDA allow off- label drug promotion to patients or consumers.
    7. 7. 2016. Pharma Marketing Network. All rights reserved. Off-Label DTC Survey 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?
    8. 8. 2016. Pharma Marketing Network. All rights reserved. Off-Label DTC Survey 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
    9. 9. 2016. Pharma Marketing Network. All rights reserved. Off-Label DTC Survey 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
    10. 10. 2016. Pharma Marketing Network. All rights reserved. Off-Label DTC Survey INVIBE SURVEY* RESPONDENT PROFILE N = 51 40 Patient Advocates 20 Chronic Condition Patients 9 Caregivers 100% are U.S. based *Voice-response survey sponsored by Pharma Marketing News Conditions: • Diabetes (8) • Fibromyalgia (7) • Arthritis (5) • CHF (5) • Back Pain (4) • Migraine (4) • Asthma (3) • Crohn’s Disease (3) • Hypertension (3) • Rheumatoid Arthritis (3) • Sjogren’s Syndrome (3) • Other (12)
    11. 11. 2016. Pharma Marketing Network. All rights reserved. Off-Label DTC Survey SUMMARY OF RESULTS Do you think the FDA should allow off-label promotion of drugs to consumers by drug companies as long as the promotions (magazine and TV ads) provide truthful information based on current science.
    12. 12. 2016. Pharma Marketing Network. All rights reserved. Off-Label DTC Survey SELECTED COMMENTS FROM PATIENTS Comments against:Comments in favor: Click icons above to hear comments or go here: http://bit.ly/OffLabelPatientSurvey
    13. 13. 2016. Pharma Marketing Network. All rights reserved. Off-Label DTC Survey THANKS FOR VIEWING!

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