Compliant Connections in an Increasingly Connected Population€¦ · Same regulatory audience...

Compliant Connections in an Increasingly Connected Population

Connecting platforms into one campaign

Past

Multichannel marketing

Journal ads

Fax

Direct Mailers Paper detail aids Internet

Past

Mailer

16%

Audio Visual

6%

Journal

14%

Opinion

2%

Detail Aid

41%

Service Vehicle

21%

2007 Submissions: Channel Distribution

Present

Paper Detail Aids

Mailer

8%

Audio Visual

25%

Journal

5%

Opinion

3%

Detail Aid

41%

Service Vehicle

17%

PI

1%

2013 Submissions: Channel distribution

Mailers

Mailer

8%

Audio Visual

25%

Journal

5%

Opinion

3%

Detail Aid

41%

Service Vehicle

17%

PI

1%


Audio Visual

Mailer

8%

Audio Visual

25%

Journal

5%

Opinion

3%

Detail Aid

41%

Service Vehicle

17%

PI

1%


Journal Ads

Mailer

8%

Audio Visual

25%

Journal

5%

Opinion

3%

Detail Aid

41%

Service Vehicle

17%

PI

1%


Audio-Visual

Audio Visuals

22%

E-detail aid

22%

Slide presentations

10%

Internet website

44%

Social media

1%

Broadcast

1%

2013 Audio-Visual breakdown

Trends

• A visible shift in media channels

• New ways to reach your audiences

• Increased opportunity to engage with costumers

So what are some key considerations when creating multichannel marketing campaigns to engage patients, HCP and consumers in a

digital environment?

Building an Omnichannel Campaign

Branded HCP App

Branded patient website

HCP direct branded mailer Social Media

campaign Wellness/adherence reward program

Corporate website

Omnichannel Campaign

Branded Patient App

Content (s.6.4.3)

Access Control (s.6.5.6)

Linkage (s.6.5.4)

Branded HCP App




Corporate website

Linkage

Branded Patient App

Branded App – Patient support program


• Branded patient app to a patient branded website and vise versa

– This is deemed acceptable and does not change the regulatory status of either platform

Branded App – Patient support program


• Branded HCP app to a patient branded website

– This is deemed acceptable and does not change the regulatory status of either platform

• Branded patient website to a HCP app

– This is not acceptable – different regulatory audiences.

• Patient branded website to corporate website

– Link from branded pre-gate landing page – Not acceptable

– Link from any page post-gate – can link to the homepage


Corporate website

Branded HCP App or HCP website Corporate website

• HCP branded app/website to corporate website

– Link from branded pre-gate landing page – Not acceptable

– Link from any page post-gate – can link to the homepage

• Corporate website to branded HCP app/website

– Must link to the landing page – haven’t verified regulatory audience yet

Branded HCP App


HCP direct branded mailer

Wellness/adherence reward program

Linkage

Branded App



Linkage

HCP Mailer to promote: Branded HCP app

Both pieces are considered branded and must be within the limitations of the TMA. Same regulatory audience Therefore can be linked


Branded App



HCP Mailer to promote: Branded patient website Different regulatory audiences: - HCP delivers service to patient therefore can have access to patient site - Patient cannot have access to promotional material – should not be granted access to HCP mailer

*Note the patient website is subject to review as it is being promoted to the patient through the HCP


Branded App



HCP mailer to promote: Unbranded wellness/adherence program • Branded HCP mailer – will require review of the

program in the context of the brand Ensure it does not go beyond the limitations of the TMA (i.e. discussion of complications of the disease)

• Unbranded HCP mailer – (i.e. promote use of program to any patient with condition X regardless of sponsors therapy – acceptable linkage)


Branded HCP App


• Branded patient or HCP app linking to an unbranded wellness/adherence reward program

– Unbranded now has to be reviewed in the context of the brand

– Copy which may have been acceptable in the unbranded context may now be challenged

Branded Patient App


• Example:

Patients adherence to their medication is important to ensure they get the full effect

Adherence to your medication is important for controlling your hypertension and reducing your risk of long-term complications such as MI or stroke

Branded HCP App Branded Patient App

Branded HCP App

Social Media campaign

Branded Patient App

• Branded HCP app or patient app linking to social media campaign

Social Media (s.6.5.9)

• Websites and applications that enable the user to create or share content or to participate in social networking • It allows for user generated content (UGC) or dynamic content

Content within areas that are under the sponsors control are subject to all the current rules and

regulations for drug advertising and other activities

The sponsor of a site with UGC functionality looses some control over the message

BUT

retains much of the regulatory risk.

Therefore…


Start by asking yourself some questions to align the site with your risk tolerance

How much control am I giving to the

audience?

Will I have site rules? What will they be? How

will I communicate them?

To what extent will the site be

moderated?

To what extent will I be monitoring? What will I be looking for?


User Generated Content

• Can render a compliant page non-compliant • Terms and Conditions

Clear and accessible e.g. clear statement about what type of comments will be removed or modified

May minimize frequency of misuse

• Monitoring the Conversation

i.e. semantic, automatic filtering mechanism (brand key words, side effects etc.)


Correcting misinformation: e.g. misinformation about company or disease

Corrections must be made promptly. PAAB preclearance not required if limited precisely to the minimum needed to correct misinformation.

Off-label discussions: Remove outright!!

Adverse event monitoring: Not enough to only provide a statement referring reporters to the pharmacovigilance / medical department.

Monitoring the Conversations:

Branded HCP App


• Dynamic content on the social media platform therefore, ask yourself:

– How is that content likely to change?

– Does that change affect the regulatory status of my app?

– What should I be aware of?

• Monitoring and moderating

Branded Patient App

Branded Patient App


• Branded patient app linking to social media campaign

– Branded (previously reviewed and approved by PAAB) - OK

– Unbranded disease support group/chat room/blogger • Sponsors responsibility to ensure that the content meets branded

patient regulations

– Violation could affect the acceptability of one or both channels

Branded HCP App Social Media campaign

• Branded HCP app linking to social media campaign

Branded (previously reviewed and approved by PAAB)

– HCP disease specific chatroom • Sponsor is responsible for ensuring the content remains on label

and meets advertising standards

– Unbranded disease support group/chat room/blogger • Sponsors responsibility to ensure that the content meets branded

patient regulations

– Violation could affect the acceptability of one or both channels

App Store: REVIEWS

1. This app provided me with all the info I needed to confidently prescribe my diabetes patient Jensulin

2. This app was no good. Froze all the time. Hard to find information I was looking for. Print outs would not load.

3. Jensulin saved my diabetes patients life. This app gave me so much information. Was easy to follow. Would recommend this app and Jensulin to anyone.

4. Hypoglycemia symptoms chart was not complete or user friendly.

• Options: • Monitor • Deactivate ‘Reviews’ section

PAABPharma

Identifies therapeutic area

Absolute claims, identifies therapeutic area

Identifies therapeutic area

Ok

App Store: RELATED APPS

Endeavour -

Patient Support

Lifestyle

FREE

Eating Well with

Diabetes

Food & Drink

FREE

Insulin Device Center

Education

Living with

Diabetes

Lifestyle

Healthy Eating

Food & Drink

Talking Tom Cat

Entertainment

Childhood Diabetes

Education

• Options: • Monitor • Remove/Deactivate this function

PAABPharma

Branded HCP App




Corporate website

Omnichannel Campaign

Branded Patient App

Now you should be ready to start your compliant connections.

Questions?

Compliant Connections in an Increasingly Connected Population€¦ · Same regulatory audience...

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