dose of digital fda pharma social media hearing testimony - adverse event reporting

Are pharma companies supposed to be private investigators? Jonathan Richman Director of Strategic Planning, Bridge Worldwide Author, Dose of Digital

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This is my testimony that I will present to the FDA at the upcoming hearings on the use of social communications in pharma. This specifically will address their question regarding adverse event monitoring and reporting

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Page 1: Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting

Are pharma companies supposed to be private investigators?

Jonathan RichmanDirector of Strategic Planning, Bridge WorldwideAuthor, Dose of Digital

Page 2: Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting

Required for reporting:

1. an identifiable patient2. an identifiable reporter3. a specific drug or biologic involved in the

event4. an adverse event or fatal outcome

Only 1 in 500 posts have all this info.

Page 3: Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting

Is this a reportable adverse event?

Page 4: Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting

1. An Identifiable Patient

Is this “identifiable”?

Page 5: Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting

1. An Identifiable Patient

Page 6: Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting

1. An Identifiable Patient

Page 7: Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting

2. An Identifiable Reporter

Page 8: Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting

2. An Identifiable Reporter

Page 9: Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting

3. a specific drug involved in the event

I can't remember the name it was something with a R. I got the shakes so bad that I had to take beta blockers to stop them.

Page 10: Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting

4. An adverse or fatal outcome

I ‘m beginning to wonder if the Parkinson-like movement of my left hand is related to taking Lipitor

Page 11: Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting

In the “Old Days”...

Page 12: Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting

A New Reality1

1. an identifiable patient2. an identifiable reporter3. a specific drug or biologic involved in the event4. an adverse event or fatal outcome

Page 13: Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting

A New Reality

HealthGuy

Page 14: Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting

Page 15: Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting

New Guidance Needed?

1. an identifiable patient2. an identifiable reporter3. a specific drug or biologic involved in the

event4. an adverse event or fatal outcome

Page 16: Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting

New Guidance Needed?

2. an identifiable reporter

Page 17: Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting

New Guidance Needed?

Page 18: Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting

New Guidance Needed?

1. an identifiable patient2. an identifiable reporter3. a specific drug or biologic involved in the

event4. an adverse event or fatal outcome

Page 19: Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting

Jonathan RichmanDirector of Strategic Planning, Bridge WorldwideAuthor, Dose of Digital

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