overcome hurdles to effective pharmaceutical marketing

© 2016 Pharmaguy™

Overcome Hurdles to Effective Pharmaceutical Marketing

PharmaGuyBrighTALK Webinar

18 February 2016


• Regulatory Laws• Self-Regulatory Guidelines/Ethics• Transparency Issues• Patient Power & Patient Centricity• Digital Disruption

Hurdles to Overcome


Context: High Drug Prices


Context: Bad Boy CEOs


Context: Politics

Let Medicare negotiate drug prices, eliminate

advertising tax deduction, import

cheaper drugs from Canada, etc.


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


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


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


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


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


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


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


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


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


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



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


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


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?”



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


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)

http://bit.ly/eHealthCode

http://bit.ly/eHealthCode


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


Digital Disruption

Source: DIgital Insights Group


Value of Digital Channels: HCP vs Pharma Views

http://bit.ly/digchannelvalue


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


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”

http://bit.ly/FDAspaceGuide

http://bit.ly/FDAspaceGuide

http://bit.ly/FDAmisguide

http://bit.ly/FDAmisguide


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.


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


Roche Publicly Discloses Social Media Principles


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.


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


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


Thank You!