Speakers:

Khatereh Calleja, JD Senior Vice President, Technology and Regulatory Affairs

Sandra Cohen Kalter, Vice President and Chief Regulatory Counsel, Medtronic

Geoffrey M. Levitt, Senior Vice President & Associate General Counsel,

Regulatory & Policy, Pfizer, Inc.

Moderated by Iris Gibbs, Associate Director, Advertising and Promotions, Regeneron Pharmaceuticals, Inc.

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Patient Engagement in the FDA Industry Perspective on FDA

Guidances

Industry Perspective on FDA Guidances and

Challenges in ImplementingCase of Evolving Guidance re.

Social Media and Internet Promotion

Khatereh Calleja, JDSenior Vice President, Technology and

Regulatory Affairs

October 1, 2015

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• Background/DescriptionBackground/Description

• Initial ConsiderationsInitial Considerations

• Long Road to GuidanceLong Road to Guidance

• What We Learned What We Learned

• Where We Are Where We Are

• Other Guidance to WatchOther Guidance to Watch

• Way ForwardWay Forward

Outline

• AdvaMed is the world’s largest association representing manufacturers AdvaMed is the world’s largest association representing manufacturers

of medical devices, diagnostic products, and medical information of medical devices, diagnostic products, and medical information

systems.systems.

• AdvaMed member companies produce the technologies that are AdvaMed member companies produce the technologies that are

transforming health care through earlier disease detection, less transforming health care through earlier disease detection, less

invasive procedures, and more effective treatments. invasive procedures, and more effective treatments.

AdvaMed Description

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• Piecemeal approach to advertising and promotion issues has often Piecemeal approach to advertising and promotion issues has often

been challenging amidst uncertain environment and limited guidance been challenging amidst uncertain environment and limited guidance

i.e., online/social media & scientific exchange i.e., online/social media & scientific exchange

• Important to distinguish key differences in drug and device regulatory Important to distinguish key differences in drug and device regulatory

frameworks and how devices are developed and used frameworks and how devices are developed and used

Initial Considerations

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• FDA internet/social media hearing and collection of docket comments FDA internet/social media hearing and collection of docket comments

(11/09 - 3/10)(11/09 - 3/10)

• FDASIA Sec. 1121-guidance on product promo using internet, including FDASIA Sec. 1121-guidance on product promo using internet, including

social media (7/12)social media (7/12)

• Long awaited (draft) social media guidances (6/14)Long awaited (draft) social media guidances (6/14)

• Presentation of risk information when character space limits

• Correcting 3rd party misinformation

• One more earlier in year (not for devices)

Long Road To Guidance: Ex.of Social Internet/Social Media

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• Regardless of media, statements must be truthful and non-misleading, Regardless of media, statements must be truthful and non-misleading,

balanced, and consistent with labelingbalanced, and consistent with labeling

• Promotion not necessarily rendered false and misleading by Promotion not necessarily rendered false and misleading by

use of a linkuse of a link

• Manufacturers are responsible for their own communications and Manufacturers are responsible for their own communications and

promotionspromotions

What We Learned (or Knew Already)

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• One size fits all approach can create hurdles (e.g., highlighting 1 risk in One size fits all approach can create hurdles (e.g., highlighting 1 risk in

device tweet)device tweet)

• Recommended approaches can be clunky and even prohibitive (e.g., Recommended approaches can be clunky and even prohibitive (e.g.,

multiple segmented links may not serve fair balance versus centralized multiple segmented links may not serve fair balance versus centralized

info) info)

• Scope can be limited and not have answers for all (e.g., what about Scope can be limited and not have answers for all (e.g., what about

other evolving platforms beyond Twitter and sponsored links?)other evolving platforms beyond Twitter and sponsored links?)

What We Learned, Challenges

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• Helpful rules of road (e.g., may incentivize voluntary corrections)Helpful rules of road (e.g., may incentivize voluntary corrections)

• Examples are always helpfulExamples are always helpful

• Make clear conceptual boundaries (e.g., firms not responsible for Make clear conceptual boundaries (e.g., firms not responsible for

monitoring entire Internet or addressing all misinformation)monitoring entire Internet or addressing all misinformation)

• Answer questions, but sometimes raise additional ones Answer questions, but sometimes raise additional ones

What We Learned: More Food for Thought

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• Manufacturers focused on minimizing risk and Manufacturers focused on minimizing risk and

training/implementation of SOPstraining/implementation of SOPs

• High public health value of new emerging media for education and High public health value of new emerging media for education and

awareness, but barriers remain and need to ensure flexible policies awareness, but barriers remain and need to ensure flexible policies

that work for diversity of products that work for diversity of products

• Challenges for both FDA and industryChallenges for both FDA and industry

Where We Are: Byproduct of Limited Guidance

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• Links to 3rd Prty Sites in Internet/Social Media Links to 3rd Prty Sites in Internet/Social Media

• Another key area for helpful policy, but status unclear—scientific Another key area for helpful policy, but status unclear—scientific

exchangeexchange

Other Guidance to Watch

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• Clearly significant efforts invested by FDA to develop guidanceClearly significant efforts invested by FDA to develop guidance

• Valuable to industry; help reduce gray areasValuable to industry; help reduce gray areas

• Continuing challenge of balancing targeted solutions with Continuing challenge of balancing targeted solutions with

comprehensive policies comprehensive policies

• Cross-center collaboration will be importantCross-center collaboration will be important

• Encourage collaborative industry-FDA dialogue where at all possible Encourage collaborative industry-FDA dialogue where at all possible

(early and often)(early and often)

Way Forward

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FDLI Advertising and Promotion Conference

Industry Perspective on FDA Guidances

October 2, 2015

Sandra Cohen Kalter, Vice President and

Chief Regulatory Counsel, Medtronic

• FDA has substantially increased the resources devoted to generating guidance documents – Notwithstanding concerns about particular elements of

certain guidance documents, theyde-mystify FDA’s thinking about certain activities

– Since 2009, FDA has issued a number of guidance documents relating to promotional issues

• Presentation of risk information & direct to consumer communications

• Unsolicited requests/questions guidance

• Dissemination of reprints, clinical practice guidelines, & reference texts

• 2 social media guidances for device companies

FDA’s Recent Guidance Efforts: Social Media

– FDA issued three draft guidance documents addressing various aspects of social media (one does not pertain to devices)

– Overall takeaways:• Some products, such as those with a high-risk of serious side-

effects, are not good candidates for space-constrained advertising platforms like Twitter because of the inability to provide FDA-required risk and safety information

• Manufacturers may be responsible for content produced by third parties over which they have some level of control, such as paid experts and affiliated speakers

• All content must be truthful and not misleading, as well as presented in a balanced manner that includes risks and benefits in each promotional communication

FDA’s Recent Guidance Efforts: Correcting Misinformation

• Draft Guidance provides steps manufacturers can take if they wish to correct misinformation– Firm must correct misinformation on its own websites, websites it

controls, or postings made by employees or agents on third-party sites

– Firms may choose to correct other misinformation

• Corrective communications should be:– Relevant to the misinformation, limited and tailored, accurate and

nonpromotional

– Consistent FDA labeling and/or supported by evidence

– Posted in conjunction with the misinformation

• Manufacturers may choose to correct only certain misinformation but must correct all misinformation in the “clearly defined portion” of the forum

FDA’s Recent Guidance Efforts: Character Space Limitations

– Does not make significant accommodations from general promotional and advertising requirements for platforms with character space limitations

– If a manufacturer makes a benefit claim, it must include information about the product’s most serious risks within the same communication

– Manufacturer should include a way for customers to access more complete information about risks associated with a product, such as providing a hyperlink to a page describing only risk information

– Hyperlink should be direct, and landing page should not be promotional in tone or content

FDA’s Recent Guidance Efforts: Interactions with Patient Groups

– FDA distinguishes between information presented to HCPs and information presented to patients or consumers

– Information disseminated to patient groups should be:• Truthful and not misleading

• Center around patient needs, product education, and/or access

• Include a fair balanced presentation of product data with safety and efficacy discussions

• Be in accordance with FDA-approved product labeling or IFU and supported by valid scientific evidence

• Not involve offering or providing anything of value to induce the purchase or use of medical devices

• Avoid unnecessary access to protected health information

• Refer patients to their healthcare professionals for more information

FDA’s Recent Guidance Efforts: Responses to Unsolicited Questions

– Addresses company responses to unsolicited questions regarding off-label uses

• Unsolicited requests are initiated by persons or entities that are completely independent of the manufacturer

• Requests that are prompted in any way by a manufacturer or its representatives are not unsolicited requests

– Draft Guidance distinguishes between public and non-public requests

– Non-public requests are directed privately to a company using a one-on-one communication approach

– Public requests are made in a public forum, and may be directed to a company specifically or to a forum at large

2014 Draft Guidance Covers Re-Prints, CPGs and Reference Texts

– Publications distributed as recommended will not be used as evidence of an intent that the product be used for an unapproved new use

– FDA recognizes that public health may benefit from HCPs receiving truthful and non-misleading scientific or medical publications on unapproved new uses

– Discusses dissemination of third-party data where the company has a financial relationship

FDA’s Recent Guidance Efforts: Dissemination of Scientific and Medical Publications

Hallmarks of Appropriate Articles/Texts Independently published Current Authored by subject matter

experts Peer reviewed by subject matter

experts Based on a systematic review of

existing evidence Widely available through

independent channels Disseminated independent of

promotional literature Separate criteria for distributing

portions of texts

Include a permanently affixed, prominently displayed statement disclosing:

Manufacturer Fact that off-label uses are

included Financial interests of authors, if

applicable Include a copy of approved

labeling or IFU if one or more text chapters is dedicated to a discussion manufacturer’s product(s)

Pegged to IOM’s criteria for trustworthiness

Based on a systemic review of the existing evidence

Developed by knowledgeable, multidisciplinary panel of experts and representatives from key affected units

Considers important patient subgroups and patient preferences

Transparently developed and funded to minimize biases

Provides a logical explanation of care options

Is reconsidered and revised to reflect new information

When distributing a CPG, manufacturer should:

Disseminate the most current version

Distribute CPG separately from promotional materials and not in promotional venues

Ensure it is properly labeled with disclosures

If portions of the CPG contain a primary substantive discussion of an individual product, include the approved labeling or IFU

Clinical Practice Guidelines (CPGs)

• In the form of a special supplement or publication that was funded by a manufacturer of the product at issue

• Marked, highlighted or summarized, by the manufacturer, in writing or orally, to emphasize an unapproved use

• Primarily distributed by a manufacturer; should be generally available

• Written, edited, or excerpted specifically for, or at the request of, a manufacturer

• Edited or significantly influenced by or at the request of the manufacturer

• Attached to specific product information (other than the approved labeling/IFU)

Materials disseminated should not be:

Industry Perspective on FDA Guidances

Geoffrey M. Levitt, Senior Vice President & Associate General Counsel, Regulatory &

Policy, Pfizer, Inc.

October 1, 2015

The Guidance Document

• Explains FDA’s interpretation of, or policy on, a regulatory issue

• Primary audience is regulated industry• Also useful for staff or other stakeholders• May address, among other matters, scientific

issues and enforcement policies• Not legally binding, but shows a way to reach a

regulatory goal (safe harbor)

The Guidance Process• Addressed in statute (FDCA sec. 701(h)) and regulation (21 CFR

10.115) - GGP

• May be initiated internally or externally

• Developed by a working group; reviewed at Center level and then (depending on issue) HHS and OMB

• Stakeholder input should be a significant part of the process (but not required in advance)

• Recommendations for guidance topics

• Comments on draft guidances

• Public meetings/workshops

• Guidances are “critical to support industry efforts to comply with the law” and “develop new products that may benefit the public health”

• Should be “relevant, timely, and easy to find”

Guidances Today

• Have eclipsed regulations as means of communicating agency expectations

• Increasingly enshrined in legislation

• Offer flexibility (relevant), relative speed (timely)

• Loss of transparency, process protections?

COMMIT

THANK YOUTHANK YOU

Questions?

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