Pharma:
Pharma:
Pharma:
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Darshan Kulkarni,<br />
Pharm.D, MS, Esq.<br />
Principal Attorney<br />
<strong>Pharma</strong>:<br />
Developing a Social<br />
Media Policy
Disclaimer<br />
THIS INFORMATION DOES NOT CONSTITUTE LEGAL<br />
ADVICE. TO DETERMINE IF ADVICE IS APPROPRIATE<br />
FOR YOU, YOU MUST TALK TO A LAWYER AT THE<br />
FIRM AND CREATE AN ATTORNEY-CLIENT<br />
RELATIONSHIP.
Pharm.D<br />
JD<br />
MS in<br />
QA/RA
Entrepreneur<br />
Attorney<br />
Author<br />
<strong>Pharma</strong>cist<br />
Educator<br />
Regulatory
Compliance<br />
Legal<br />
Regulatory
Par<br />
<strong>Pharma</strong><br />
Unsolicited<br />
Off Label<br />
Guidance<br />
Clin. Trial Payments to<br />
Uni. Hospitals > FMV<br />
Updates<br />
Sunshine<br />
Act<br />
Guidance<br />
Alfred<br />
Coronia<br />
Case<br />
Fines<br />
Citizens<br />
Petition
What are 3 elements you want in your<br />
employee's company Twitter account?<br />
1. ______________________<br />
2. ______________________<br />
3. ______________________<br />
Your Social<br />
Media Policy
• What is this presentation NOT about?<br />
• Social Media Definition<br />
• Participating in Social Media- Pros & Cons<br />
• Review of FDA Promotions<br />
• General Tips in Social Media Policies<br />
• Current State of Social Media & <strong>Pharma</strong> Today<br />
• Good Promotion Practices<br />
• Crystal Ball<br />
• Take Away<br />
Outline
What is this<br />
presentation NOT<br />
about?<br />
Should you do social media?<br />
• 80% of Internet users have for such as a specific<br />
disease or treatment.
What is this<br />
presentation NOT<br />
about?<br />
How to do social media?<br />
I am not a marketing guy.
What is this<br />
presentation NOT<br />
about?<br />
How to evaluate ROI?<br />
Not my focus or specialty.
Definition<br />
What is social media?<br />
Is it a bird??<br />
Is it a plane?<br />
No... It’s _____________________________
Participating in<br />
Social Media<br />
Pros and Cons
Pros<br />
• That’s where most of your patients are.
Pros<br />
• It is instantaneous.
Pros<br />
It reaches a wide audience.
Cons<br />
• Once something is out there, there is no<br />
taking it back.
Cons<br />
• There is so much information out there.<br />
How do you control it?
Cons<br />
• If I don’t know about it, do I have plausible<br />
deniability?
Cons<br />
• Difficult to measure ROI
Cons<br />
• Inadequate Guidance
Social Media<br />
Policies<br />
General Discussion
Code of Conduct<br />
Sexual Harassment Policy<br />
Discrimination Policy<br />
Confidentiality<br />
Use of Company Logos/ Images
• Cross-linking v. Downloading<br />
policies<br />
Social Media Dos
• DMCA Concerns<br />
•Have take down policies in place<br />
Social Media Dos
Monitor company owned electronics<br />
Social Media Dos
Decide which sites you will “adopt”<br />
• Monitor those sites<br />
Social Media Dos
Record Keeping<br />
Updates<br />
Do you have right<br />
policies/ Procedures<br />
Do you have MSL/<br />
Med Aff Buy-in?<br />
Social Media Dos<br />
Are you going to have off-label<br />
discussions?
You are the brand manager for a drug that is FDAapproved<br />
for GERD. You found a great explanation<br />
for GERD on YouTube. Should you post a link using<br />
your corporate Twitter account to that GERD page?<br />
What Should You Do?
Social Media Don'ts<br />
1. Both union and non-union workplaces are<br />
subject to National Labor Relations Act (NLRA)<br />
and National Labor Relations Board (NLRB).<br />
2. NLRB has filed several complaints against<br />
companies for firing employees based on their<br />
Facebook postings - postings were protected<br />
activity.
Social Media Don'ts<br />
Using parent/subsidiary policy may<br />
result in global exposure.<br />
• Piercing the corporate veil.
A physician, your personal friend, is<br />
looking for information on GERD. Your<br />
company sells medication for reflux.<br />
You are the marketing manager, and<br />
are hence aware of the latest standard<br />
of care guidelines on GERD. You<br />
happen to know that they are posted<br />
on a reputable website:<br />
www.MDGERDlink.com. Can you link<br />
to the information for your friend using<br />
a personal account?<br />
What Should You Do?
Promotions<br />
Recap
Promotions v.<br />
Scientific Discussions
Types of<br />
DTC Ads<br />
• Help Seeking Ad<br />
• If done right, governed by FTC<br />
• Cannot use name of drug
Types of DTC Ads<br />
Reminder Ad<br />
• Can use name of drug<br />
• Cannot hint/name disease
Types of DTC Ads<br />
Product Claim Ad<br />
• Can name drug and disease<br />
• Must balance with risks of drug
Social Media and <strong>Pharma</strong><br />
The Current Status
Current State<br />
• Distinguish between controlled<br />
and uncontrolled sites
Current State<br />
• Off-label discussions:<br />
• - When is there a solicitation?
Current State<br />
• Astra Zeneca: Twitter Chats
Mistakes &<br />
Miscommunications<br />
• The “one click rule" is dead<br />
• 2009<br />
• 14 companies concerning Google banner ads:<br />
• Failed to include risk information<br />
• FDA stated it "never had what some are referring to as a<br />
one click rule”
• The "Invisibility Rule" does not exist<br />
o What happened?<br />
o What if the "patient/audience" caused<br />
the meta-data to appear?<br />
The Invisibility Rule
Open Questions<br />
• Brief summary with limited space<br />
• Correcting misinformation
Enforcement Actions<br />
Trending
Examples of<br />
Enforcement Actions<br />
• Facebook widget: Metadata<br />
• YouTube: Shire/ Adderall XR:<br />
Overstatement of efficacy<br />
• Omitting risk<br />
• Wikipedia: Who edits? Controls?
What Should You Do?<br />
You are the brand manager of a new<br />
GERD medication that was launched 4<br />
months ago. You notice that your<br />
brand’s competitor has edited your<br />
drug’s Wikipedia page to add side<br />
effects that have not been associated<br />
with your drug.<br />
1. Edit the Wikipedia page from your office computer to<br />
reflect actual SEs observed.<br />
2. Go home and edit the Wikipedia page to reflect the<br />
actual SEs observed.<br />
3. Have your 22-year-old son edit the page from his<br />
dorm room in southern California.<br />
4. None of the above
What Should You Do?<br />
This time, you notice that a patient edited<br />
your Wikipedia page to add a new<br />
indication that, while it is the standard of<br />
care, is not an FDA-approved indication.<br />
Option 1<br />
Option 2:<br />
Option 3<br />
Edit wikipedia page from your<br />
office<br />
Do nothing<br />
Something else (if so, what)
Enforcement Actions
Why is MLR Pushing Back?<br />
Company<br />
Level<br />
Fines<br />
Exclusions<br />
Sale of Company<br />
Individual<br />
Level<br />
Fines<br />
Exclusions<br />
Criminal Penalties<br />
Personal Shame<br />
Loss of Licenses
Good Promotion<br />
Practices
Good <strong>Pharma</strong> Social Media<br />
Promotion Practices<br />
• Have a social media policy in place
Good <strong>Pharma</strong> Social Media<br />
Promotion Practices<br />
• Who represents the company?
Good <strong>Pharma</strong> Social<br />
Media Promotion<br />
Practices<br />
• Do things need to be run by<br />
legal/compliance?
Good <strong>Pharma</strong> Social Media<br />
Promotion Practices<br />
• What happens with reported AEs?
Good <strong>Pharma</strong> Social Media<br />
Promotion Practices<br />
• Will you promote a product/disease/<br />
company/risk mitigation?
Monitor<br />
Use Third Parties to<br />
evaluate without bias<br />
Follow<br />
Up on<br />
Risks<br />
Create<br />
SOPs<br />
Identify<br />
Risks
Crystal Ball<br />
The Future of Social Media in <strong>Pharma</strong>
Your SM Policy<br />
What are 3 elements you want in your<br />
employee's company accounts?<br />
1.______________________<br />
2.______________________<br />
3.______________________
Do they<br />
represent<br />
Company?<br />
Which division of<br />
company do they<br />
represent?<br />
Link to terms of<br />
engagement<br />
Can you take<br />
AEs<br />
If no, where<br />
should they<br />
be reported?<br />
What is site’s<br />
purpose?<br />
Explain why<br />
you cant<br />
engage
Social Media Guidances<br />
FDA is expected to have the following guidances:
Responding to unsolicited requests<br />
Fulfilling regulatory requirements when using tools<br />
associated with space limitations<br />
Fulfilling post-marketing submission requirements<br />
Online communications for which manufacturers,<br />
packers, or distributors are accountable<br />
Use of links on the Internet
Future of Social<br />
Media<br />
• DDMAC is dead. Long live OPDP.
IMS v.<br />
Sorrell<br />
Citizens<br />
Petition<br />
Par<br />
<strong>Pharma</strong><br />
Alfred<br />
Coronia
... but we don’t have<br />
all the SM Guidances?<br />
FDA has continually said:<br />
• Don’t expect rules to change<br />
• Clarifications will be provided
Take Away<br />
• The rules have changed.<br />
• It’s a brave new world out there.<br />
• But: If they don’t give you a<br />
map, they blame you for not<br />
following directions
Questions?<br />
@FDALawyers<br />
Join us to chat at #rxcom<br />
@9pm on 1 st Monday of every month
Darshan Kulkarni<br />
Darshan@conformlaw.com<br />
Phone: 215-703-7842<br />
http://www.conformlaw.com
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