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CBI - 13th Annual Guidelines for Disseminating Off- Label Information
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What activities did you attend at the event?
Agreement
By completing this form, you attest that you have participated in all selected activities in thier entirety.
Please rate the following:
The program was relevant to my work.
Content matched stated objectives.
Usefulness of handouts/AV.
Quality of facilities.
How well did the educational sessions give a balanced view of therapeutic options, including the use of generic names?
If you rated any of the above questions with 'fair,' 'poor,' 'disagree,' or 'strongly disagree' please explain:
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Objective 1: Discuss Park Doctrine prosecutions and individual criminal liability.
By meeting the above objective my professional competence will increase because I have acquired new strategies to use in my practice.
By meeting the above objective my professional performance will improve because I should be able to implement the new strategies.
By meeting the above objective my patient outcomes should improve due to the implementation of newly-learned strategies.
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
Objective 2: Describe new initiatives to enhance regulatory clarity.
By meeting the above objective my professional competence will increase because I have acquired new strategies to use in my practice.
By meeting the above objective my professional performance will improve because I should be able to implement the new strategies.
By meeting the above objective my patient outcomes should improve due to the implementation of newly-learned strategies.
Objective 3: Explain the pre-approval communication, clinical trials and publication planning risk areas.
By meeting the above objective my professional competence will increase because I have acquired new strategies to use in my practice.
By meeting the above objective my professional performance will improve because I should be able to implement the new strategies.
By meeting the above objective my patient outcomes should improve due to the implementation of newly-learned strategies.
Discuss how the Dodd-Frank whistleblower provisions are being used to pursue violations of the FDPA.
Examine trends in the number of pharmaceutical and device complaints and qui tam settlements.
Discuss corporate and individual risk mitigation strategies that can facilitate a more favorable resolution of a government inquiry without necessarilyopening the door to additional allegations and exposure.
Discuss the partnership between qui tam counsel and the government when investigating  cases differences between various federal districts and differences between the level of cooperation with the states (versus the federal government).

Discuss the striking rise of activity by state Attorneys General offices and new efforts to prosecute off-label promotion via state consumer protection laws.

Discuss the case study, hear first-hand from one of the attorneys who tried the case to understand the allegations and arguments used by the defense in achieving its successful resolution.
Identify top priorities for enforcement.
Discuss types of alleged wrongdoing.
List recommendations from the government on what manufacturers can do to monitor for off-label promotion and mitigate risks of non-compliance.
Discuss where DDMAC is within their draft guidance process.
Dissect recent untitled and warning letters.
Analyze FDA risk areas including failure to include relevant safety information, overstatements of efficacy/misbranding, unsubstantiated/off-label claims, adverse event reporting, etc.
Evaluate FTC considerations including transparency and disclosure requirements, and using real patients versus actors in testimonials.
Develop Policies and Processes to Mitigate Risk Areas.
Implement policies that address corporate issues.
Discuss guidelines for appropriate scientific exchange as distinct from off-label promotion.
Discuss breadth of exposures across program/activity types.
Discuss drivers of compliance across field staff.
Discuss the importance of establishing a baseline and measuring success.
Evaluate the benefits and challenges of different monitoring tools/approaches.
Discuss the value of effective communication to internal and external audiences.
Discuss the implications of the petition in the context of the constitutional issues and public health considerations informing FDA’s approach to off-label promotion issues. Participants learn about the impetus for the petition, the current state of the law on off-label promotion and the rationale supporting the selection of the four issues identified in the petition as requiring additional clarity.
Discuss appropriate and inappropriate language to use when seeking patients for studies for additional (unapproved) indications for an approved product.
Discuss whether or not branding (using both trade name and/or study acronyms) is a good idea for study recruitment advertising.
Discuss considerations related to clinical research and medical social media efforts, in particular when there are fewer controls over two-way communication with patients.
Review recent enforcement activities and considerations affecting product sponsors and related parties (e.g., investigators) who discuss pre-approval activities and findings.
Explain how a decision supports investigator-initiated research or how sponsor clinical trials affects risk both pre-and post-approval.
Discuss practical suggestions for communicating information about products that have a high off-label usage, without promoting the product’s off-label indications.
Discuss the types of materials that go before a review committee.
Explore areas of communication that frequently pose the greatest risk for potential off-label promotion.
Review recent enforcement actions related to off-label promotion.
Explain how each function area (Legal, Marketing, Medical, Regulatory, etc.) within a promotional review committee can help to mitigate risk of off-label promotion.
Develop best practices to ensure you are optimizing the efficiency of your promotional review committee.
Discuss the conflicting requirements imposed by the FDAAA and other federal and state statutes pertaining to dissemination of safetyrelated information to healthcare professionals that reference off-label uses and methods pharmaceutical companies can develop to reduce liability risks.
Analyze the recent developments addressing this issue, the Allergan litigation brought against the FDA and the resulting CIA and potential future consequences for the pharmaceutical industry.
Measure the best ways to structure knowledge development and to communicate research results.
Identify what business plans and reimbursement strategies  have to do with it.
Objective 4: Discuss substantiating product claims during promotional copy review.
By meeting the above objective my professional competence will increase because I have acquired new strategies to use in my practice.
By meeting the above objective my professional performance will improve because I should be able to implement the new strategies.
By meeting the above objective my patient outcomes should improve due to the implementation of newly-learned strategies.
Objective 5: Discuss liability for off-label dissemination as part of REMS.
By meeting the above objective my professional competence will increase because I have acquired new strategies to use in my practice.
By meeting the above objective my professional performance will improve because I should be able to implement the new strategies.
By meeting the above objective my patient outcomes should improve due to the implementation of newly-learned strategies.
Please answer the following:
Do you believe this activity was appropriate for the scope of your professional activities?
Was the educational content scientifically sound?
Was the educational content free of commercial bias?
Was the mode of education effective to learning?
If you answered "No" to any of the above questions, please explain.
Were you solicited by sales personnel in an educational room while you attended this educational activity?
If you answered "Yes" to the above question, please explain.
What did you learn during this activity that you intend to integrate into your practice?

What questions have arisen in your practice for which you need answers/strategies that you can implement?

What patient/client problems or patient/client challenges do you feel you are not able to address appropriately or to your satisfaction?
What problems are your patients/clients communicating to you that need attention or follow up?

Are you interested in basic, intermediate or advanced level trainings?

What barriers might you have that would interfere with implementation of new information learned from this training?

How can this training (the overall meeting) be improved to better impact competence, performance and/or patient/client outcomes?

Additional comments:

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