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© 2016 Pharmaguy™
Overcome Hurdles to Effective Pharmaceutical Marketing
PharmaGuyBrighTALK Webinar
18 February 2016
© 2016 Pharmaguy™
• Regulatory Laws• Self-Regulatory Guidelines/Ethics• Transparency Issues• Patient Power & Patient Centricity• Digital Disruption
Hurdles to Overcome
© 2016 Pharmaguy™
Context: High Drug Prices
© 2016 Pharmaguy™
Context: Bad Boy CEOs
© 2016 Pharmaguy™
Context: Politics
Let Medicare negotiate drug prices, eliminate
advertising tax deduction, import
cheaper drugs from Canada, etc.
© 2016 Pharmaguy™
Result: New Anti-DTC Movement
On December 9, 2015, I wrote this headline in response to AMA’s call for law to ban DTC ads: “Passing Law to Ban DTC Drug Ads About as Likely as Trump Being Elected President”
Seems a lot more likely now!
http://sco.lt/7NoUtd
© 2016 Pharmaguy™
Fewer FDA Enforcement Actions
FDA is issuing fewer enforcement letters. Why?
Are pharma marketers getting more “savvy” about complying with regulations?
The 2 “warning” letters went to smaller. lesser known pharma companies. Are they less experienced or bigger risk takers than Big Pharma?
Are marketers staying away from risky channels having less guidance from FDA – i.e., social media?
http://bit.ly/PMBdeep2016
© 2016 Pharmaguy™
Blatant Violations Generate Warning Letters
This Instagram ad for Diclegis, posted by celebrity Kim Karsahian, does not mention any side effects – i.e., lacks fair balance.
“One- click Rule” defense rejected by FDA
Small Canadian company paid for the ad but a large US marketing/PR firm, which claims to have a good grasp of regulatory issues, implemented the campaign.
4 out of the 9 letters involved digital media.http://bit.ly/omgkimkar
© 2016 Pharmaguy™
Types of Primary Violations Cited
12 primary violations Risk minimization (e.g., as in
Diclegis Instagram post) and unsubstantiated claims were most often cited.
6 other types of violations include inadequate communication of indication, omission of material fact, and lack of adequate direction for use
Nothing specifically digital relatedhttp://bit.ly/PMBdeep2016
© 2016 Pharmaguy™
Codes of Practice & Ethics
Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals
Association of the British Pharmaceutical Industry (ABPI Code) of Practice administrated by the Prescription Medicines Code of Practice Authority (PMCPA)
PhRMA DTC Advertising Guidelines eHealth Code of Ethics
© 2016 Pharmaguy™
Self-Regulation: ABPI Code of Practice
Promotion of Pradaxa by Boehringer Ingelheim breached ABPI Code of Practice
Press release encouraged members of the public to ask their health professional to prescribe Pradaxa for an unlicensed indication
Press articles disparaged warfarin, a current option, referring to it as a rat poison
BI rule responsible for remarks made by health professional & patient spokespersons to mediahttp://bit.ly/BI-Parrot
© 2016 Pharmaguy™
Transparency is Difficult
EFPIA: “The pharmaceutical industry recognises that it has a responsibility to show leadership in advancing responsible transparency.”
“Consumer Opinion Leaders” (COLs) and patient bloggers are pharma's “secret sauce” for social media marketing.
E.g., “Living Like You,” a Novartis Pharma AG website, Facebook page, and Twitter account driven by a “community” of patient bloggers
At first, Novartis did not reveal that payments were made to bloggers. Then I blogged about it. Now, Novartis acknowledges in a footnote that contributors are paid: “Living Like You bloggers are financially compensated at a reasonable market rate for their time. Payments to bloggers in no way influences their writing, opinions or perspectives on life with multiple sclerosis.”
http://bit.ly/bloggertransparency
© 2016 Pharmaguy™
Absolute Transparency
Janssen’s Social Media Toolkit for Patient Associations
Janssen is fully aware of the potential pitfall of conflict of interest posed by pharmaceutical companies and patient groups working together. That is why Janssen stipulates that such collaborations may only take place in absolute transparency, with contractual documents specifying the scope and modalities of the interaction.
Each year, Janssen posts a list of all patient groups receiving contributions and educational grant funding. The company also encourages patient groups to post this information on their sites as well. http://sco.lt/8R7E4P
© 2016 Pharmaguy™
Patient Power
Patient Centricity – the “science of patient input”
Real Patient Stories Patients demand better
mHealth apps Patient Opinion Leaders “Nothing about patients
without patients”
http://bit.ly/pmn140603p
© 2016 Pharmaguy™
The Patients Included Initiative
① Patients involved in design & planning ② Patients are speakers & in the audience③ Scholarships to pay for patient travel & accommodation ④ Disabled patients are accommodated – access to all events⑤ Virtual participation
http://bit.ly/pmn140403p
© 2016 Pharmaguy™
The Novartis Declaration for Patients
“We will listen to the important information patients and patient communities share with us on what it is like to live with their condition.
“We believe in the active participation of patients and active citizens to improve health care services and outcomes for patients. We respect the independence and integrity of patient organizations. We partner with patient organizations around the world in compliance with local laws and regulations on projects of mutual interest and benefit including disease awareness and education, better understanding the patient journey specific to each disease area, and activity in social media. We support patient activity through social media channels.
“We support ongoing patient advisory boards and roundtables in various disease areas where patient group representatives from around the world meet to actions and outcomes of areas of importance to them.”
http://bit.ly/1JFfD48
© 2016 Pharmaguy™
The Science of Patient Input
“We have heard from pharma and bio that—and they’re using the term ‘science of patient input’—is one of the most important items of discussion for the reauthorization of PDUFA,” said Theresa Mullin, director of the Office of Strategic Programs at the FDA Center for Drug Evaluation and Research.
The power, if not the science, of patient input was a major factor in the approval of Addyi
http://bit.ly/1CDNMQ8
© 2016 Pharmaguy™
Real Patient Stories
Data gives credibility, but stories provide truth
Truth trumps creativity By the patient, for the patient Can you be too “Patient-
Centric?”
http://bit.ly/pmn130702p
© 2016 Pharmaguy™
Improving mHealth Apps
Improve connectivity & integration into physician workflow
Robust data confidentiality, privacy, and regulatory compliance
Scientific evidence to measure efficacy (clinical trials for apps)
Involve patient advocates and healthcare providers in development, testing, & promotion
© 2016 Pharmaguy™
Full Disclosure Assure Accuracy Informed Consent/Good Privacy Practices Good Privacy Practices Data Security Assurance Regulatory Compliance HIPAA Compliance (where applicable)
eHealth App Guiding Principles
Based on eHealth Code of Ethics (http://bit.ly/eHealthCode)
© 2016 Pharmaguy™
Undocumented Data!
Shire hosts BingeEatingDisorder.com, “A Resource for Understanding B.E.D. in Adults”
Undocumented statistics violates eHealth Code of Ethics: Disclose to users “what sources the site or content provider has used, with references or links to those sources”
http://bit.ly/selesbinge
© 2016 Pharmaguy™
Digital Disruption
Source: DIgital Insights Group
© 2016 Pharmaguy™
Value of Digital Channels: HCP vs Pharma Views
http://bit.ly/digchannelvalue
© 2016 Pharmaguy™
Physicians Prefer Gated Social Media
http://bit.ly/doctorgate
Pfizer 2011 survey published in JMIR
Over 50% of physicians surveyed are current users of restricted online communities (such as Sermo)
Only 7% say they use Twitter in order to share medical information and stay up to date
© 2016 Pharmaguy™
Social Media Guidelines: FDA
“Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices”; http://bit.ly/FDAspaceGuide
“Internet/Social Media Platforms: Correcting Independent Third-party Misinformation About Prescription Drugs and Medical Devices”; http://bit.ly/FDAmisguide
On 2016 Guidance Calendar: “Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-Party Sites”
© 2016 Pharmaguy™
Allergan Employee Tweet Breaches ABPI Code
PMCPA ruled Allergan breached the ABPI Code on several counts after an employee accidentally tweeted publicly about Botox
Employee violated Allergan’s “Global Social Media Policy” that clearly stated “no Allergan employee might comment in a social media forum about Allergan products or business activity.”
Pharma companies should make their SM policies public to be more transparent & accountable.
© 2016 Pharmaguy™
Hired Guns & Employees on SM: What’s Your Policy?
Tweet posted on 9 Nov 2012 by an agency working on behalf of Gedeon Richter ruled breach of ABPI code
Company claimed ignorance that tweet was made
PMCPA noted it is an “established principle under the Code that pharmaceutical companies were responsible for work undertaken by third parties on their behalf.”
http://bit.ly/GRhiredgun
© 2016 Pharmaguy™
Roche Publicly Discloses Social Media Principles
© 2016 Pharmaguy™
Beyond the Brand
http://bit.ly/diehardpharma
“Die-hard” Rx brand pharma marketers need to forget about hawking brand name drugs via social media and focus on using social media to provide real benefits to patients.
© 2016 Pharmaguy™
What About Unbranded Twitter Chats?
BI has hosted several Twitter Chats concurrently with medical conferences (e.g., #COPDChat during 2014 European Respiratory Society (ERS) Congress)
Most are intended for HCPs but general public cannot be excluded
The ABPI code specifically prohibits Twitter chats even when “intended” for physicians only
BI’s disclaimer: “Not intended for UK audience”http://bit.ly/COPDtweetchat
© 2016 Pharmaguy™
Beware of Mad Men Who Push Envelope
Should pharma hire agencies that “don't know the difference between the FDA and FDR. But they know branding”?
Lesson of the “One-click Rule,” “Received Precedent,” whatever! Consultants were wrong!
Google misled pharma marketers too! Of course, your MLR people will be
the judge
http://bit.ly/mad-v-med
© 2016 Pharmaguy™
Thank You!