As you would expect, this morning has been filled with discussion about how we marketers and companies are not responsible for reporting any AEs that do not fit the 4 identifiable criteria that presently exist.

But what about going beyond hiding behind the 4 criteria and actually trying to improve the process?

A few companies had some interesting perspectives and suggestions.

PhRMA

• Per FDA ICH E2D companies are not responsible for monitoring ADRs on external sites
• Monitor your own sites and those for which you have control (without control, your ability to manage AEs is impossible)
• Companies should not have to report AEs posted in public forums

PhRMA Suggestion: Companies could, however, inject into the conversation with a statement and link suggesting poster click as they might be experiencing and AE.

Ogilvy 360

• Company should report AEs that fit all 4 criteria (wherever they are), without required follow up (could breach patient privacy)

FDA Questions to Ogilvy 360:

• How do you suggest we interact with these online communities?
• Where do HCPs and their sites fit into this (nobody has talked about HCPs this morning)?

Ogilvy 360 Answers:

• Monitoring needs to be standardized so that FDA [and companies] can interact with these communities. We need to establish consistent, reproducible standards for online reporting.
• HCPs are knowledgeable enough and educated such that they can take responsibility for their own dialogues in SM spaces. Plus, they are already overtaxed with too much paperwork and process.

Heartbeat Digital

• Burying the ISI at the bottom of the page with link to MedWatch looks like they are hiding, plus it is NOT an effective method of showing interest in safety
• 1 out of 1,000 (HealthCentral data) patients surveyed said they would actually use MedWatch

Heartbeat Digital Suggestions:

• Radcially simplify ISIs - they are too confusing for consumers
• Have companies inject into the conversations when message appears to have serious negative health implications, with link and contact info on how to report the situation
• Make it easier for patients to file an AE (MedWatch is too complex)

PatientsLikeMe

• Create an integrated pharmacogivilance form for insertion into all patient online experiences
• Fast, easy way for 2-way conversation (MedWatch is only 1-way)

FDA Questions:

• How can such a system work when many patients are on therapies with complex drug regimens?
• Any ideas on how to apply this system to medical devices?

PatientsLikeMe Answers:

• It would be possible to chart a system of all symptoms, drug interactions and compute likelihood that patient may be experiencing and AE and which drug is responsible (WOW..that is out there. Great idea, but is it doable? See below)
• PIs need to be standardized so that our software can collect the data and compute in real time. Presently this does not exist
• No system is presently in place for medical devices, however, the industry and PatientsLikeMe need to address this.

Conclusions from this morning:
While the FDA is asking lots of questions, and lots of great ideas like the above are being offered by companies and marketers, FDA is not engaging in making any suggestions or direction. Sorry to say this everyone, but it looks like we are right where we started.

For now, we have to police ourselves, form our own guidelines, use good judgement and demonstrate intent and best effort to help keep patients safe.