Transcript Disease Awareness Communications

Putting It All Together:
Better Practices Around
Monitoring And Auditing
Promotional Activities
John Manthei
March 27, 2008
Latham & Watkins operates as a limited liability partnership worldwide with an affiliated limited liability partnership conducting the practice in the United Kingdom and Italy. ©Copyright 2008 Latham & Watkins. All Rights Reserved.
Best Audit Practices
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Management "Buy In“ To Compliance
Multi-Discipline Approach
Standard Operating Procedures
Know the Law, and use it to Your Competitive Advantage!
Monitor FDA Enforcement Trends and Agency Pronouncements
Medical Device Advertising and Promotion
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Standards Vary Depending on the Medium, and Who, What, Where,
and Why
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Cleared or Approved Indications for Use
Product Labeling
Direct to Consumer Advertising
Disease Awareness Communications
The Internet
"Off Label" Communications
General versus Specific Intended Uses
Pre-approval Promotion of Investigational Devices
Clinical Trial Recruitment
Continuing Medical Education Programs
Comparative and Superiority Claims
Comparative Pricing
Investor Communications
Direct to Consumer Advertising
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Enforcement priority at FDA.
FDA’s 1999 Final DTC Prescription Drug Advertising Guidance
(1999)
Draft Guidance for Industry: Consumer-Directed (DTC)
Broadcast Advertising of Restricted Devices (March, 2004)
Consumer Directed Advertisement (DTC) must include a “brief
statement of the intended uses . . . and relevant warnings,
precautions, side effects, and contraindications.” See 21 U.S.C.
352(r)(2)).
Disease Awareness Communications
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Disease Awareness Communications involve educational
information about a specific disease or condition, but do not
mention a specific device. Disease Awareness Communications
have become a critical component of medical device marketing and
promotion.
FDA’s Draft Guidance
• Attempts to clarify the line between Disease Awareness
Communications that are outside of FDA’s jurisdiction, and
product promotion activities subject to its jurisdiction.
Disease Awareness Communications
• The company, or product need not be mentioned to trigger
FDA’s authority
• Continuing Medical Education (CME) Programs
• Educational materials for training, orientation, and product
launch
The Internet
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FDA has not developed a guidance, or policy specific to internet
advertising. However, CDRH compliance personnel frequently
monitor the Web, and FDA has aggressively enforced its
standards that apply to all advertising and product labeling.
General Guidelines
• Treat the internet the same as other media.
• You are responsible for links on your Website – no “off-label”
promotion.
• All product-specific websites for prescription drugs must be
submitted to FDA at the time of first use.
• Establish separate links for U.S. and EU approvals.
• Securities filings.
General v. Specific Intended Uses
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FDA Modernization Act of 1997
Guidance for Industry: General/Specific Intended Uses
(November 4, 1998)
The Guidance is intended to help manufacturers answer the
following questions:
• Under what circumstances is a device with a new, specific
indication for use likely to be found to be substantially
equivalent to a device legally marketed for a general
indication for use?
• Conversely, when does a specific indication for use become a
new intended use that requires submission of a PMA to
establish the safety and effectiveness of the device?
Off-Label/Preapproval Communications
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The dissemination of information on unapproved or off-label uses
and medical devices implicates competing policy and legal
considerations:
• Devices may be promoted only for FDA-cleared or approved
indications
• FDA prohibits off-label or preapproval promotion because the
safety and effectiveness of indications have not been established
(i.e., new diseases, anatomic sites, subpopulation).
• FDA does not regulate physicians’ off-label use of a device
within “the practice of medicine”
• FDA recognizes the need for scientific exchange between
physicians and investigators regarding new products and uses.
• Constitutional protection of speech under the First Amendment.
Draft Guidance on Good Reprint Practices for the Distribution of
Medical Journal Articles on Unapproved New Uses of Approved of
Cleared Devices (February, 2008)
Off-Label and Preapproval Communications
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Response to a Unsolicited Requests
Regulatory Safe Harbor (Journal articles) device
Investigational Products
Recruitment for Clinical Trials
Continuing Medical Education
Medical Devices:
Draft Guidance on Reprint Distribution
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Primary Differences between expired Section 401 and Draft
Guidance –
• The draft guidance does not bar the use of clinical research
conducted by another manufacturer without permission, and
does not currently require manufacturers to submit copies of
the publication to the FDA prior to dissemination.
• The Draft Guidance does not require submission of PMA
supplement.
Display of Medical Devices
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CDRH recognizes the need for hospitals and practitioners to
“preview” new, potentially complex and expensive medical
technology.
Companies may display devices with a pending 510(k) or IDE at
medical trade shows or conventions:
• Label stating “not available for sale in U.S.”
• May not take orders or train on device prior to
clearance/approval
• May not display off-label uses of cleared device
• No regulatory mechanism to display device with PMA
pending
Clinical Trial Recruitment
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Investigator recruitment through notices, publications, displays,
direct mailing and announcements in medical conferences on
publications:
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Identity of sponsor
How to apply
Study obligations
Clinical Trial Recruitment
Subject recruitment advertisements
• Identity of investigator and / or research facility
• Conditions and purpose of study
• Summary of eligibility criteria
• List of benefits
- Not imply favorable outcome
- Not identify benefits beyond those in informed consent
- Not claim “new treatment” without explaining product is
investigational
• Time commitment required
• Contact information
Continuing Medical Education
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Most CME programs (80%) are sponsored by drug and device
companies.
• Industry supported scientific and educational activities
(ISSEA)
FDA considers sponsorship of an ISSEA discussing the
company’s (or a competitor’s) product to be subject to labeling
and advertising requirements.
FDA’s regulation of ISSEA has been the subject of considerable
controversy and confusion.
• Final guidance on ISSEA issued in November 1997
• Subject to First Amendment challenge
• Guidance reinstated on appeal
ISSEA Final Guidance
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Activities controlled or substantially influenced by funding
companies:
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Must satisfy FDA requirements, including full disclosure and
fair balance
Must disclose interest in product, sponsorship of event and state
that use is not approved
Activities that are “independent” of the funding companies are
not subject to FDA regulation
ISSEA Final Guidance (Cont’d)
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Factors FDA considers in determining “independence”
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Control over content and selection of presenters
Disclosures (funding, content, etc.)
Focus
Relationship between provider and supporting company
Providers involvement in sales / marketing
Multiple presentations
Audience selection
Discussion opportunities
Dissemination of information after the program
Ancillary promotional activities
Complaints
No one factor is definitive.
Comparative and Superiority Claims
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FDA generally discourages claims comparing one product to
another.
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Concerns about validity of comparison
Limited or “apples-to-oranges” comparisons
CDER and CDRH take similar but not identical approach to
comparative claims for drug and devices.
Comparative and Superiority Claims: Devices
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Comparative claims must be based on reliable scientific data
Comparative Requires at least one study directly comparing the
two products
The study must be presented in its entirety identifying both
areas of superiority and any areas on inferiority
Comparative and Superiority Claims: Price
Price Advertising
• Manufacturers and distributors may advertise prices so long
as it is not false or misleading and does not address safety or
effectiveness
• must include all charges and specifics (i.e.: product
strength, dose, form, model, etc.)
• Cost effectiveness and comparative claims must generally be
based on clinical trials
Investor Communications: FDA Standards
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Although investor communications do not constitute advertising
in the traditional sense, FDA has consistently held that they are
subject to the same regulatory constraints as statements made to
consumers and the medical community.
In practice, FDA recognizes that investor communications are
not primarily intended to promote a product to physicians or
consumers, and has not aggressively exercised enforcement
authority against firms for statements made in communications
solely directed at investors.
SEC Requirements
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Section 11 of the 1933 Securities Act and Section 10b, Rule 10b-5
and Section 17a of the 1934 Act make it unlawful in a securities
transaction to:
• Make untrue statements of material fact
• Omit material facts that would make statements not
misleading acts
Primary liability for issuers knowingly suppressing or recklessly
disregarding material omissions or misstatements
Secondary liability for assisting issuer or other primary party in
violation (reasonable due diligence)
Investor Communications
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Recent investor climate has resulted in an increase in the amount
and level of detail regarding clinical and regulatory status in
investor communications.
Investor communications include:
• Annual and other periodic reports
• Prospectuses
• Initial Public Offerings (S-1)
• Press Releases
• All other securities filings and materials disseminated to the
investor community
Strategies for Compliance
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Press releases and S-1s are likely to receive both FDA and SEC
scrutiny.
Don’t get out in front of FDA.
• Don’t say your product is safe and effective until FDA says
it’s safe and effective
Be complete in discussing interim clinical trial results.
• If you are announcing results after 10 patients in a 500
patient trial, tell the whole story about the trial.
• If results are favorable but not statistically significant –
say so.
Strategies for Compliance (Cont’d)
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Be balanced
• Don’t overstate favorable results or studies or omit
unfavorable ones.
Statements to FDA and the investment community should be
consistent.
• Accurately characterize stage of clinical development or
regulatory status.
• Description of endpoint or indication should be precise.
• Clearly describe regulatory process.