Transcript NIH Consulting

FDA Regulation
of the Dissemination of
Medical Device Information
Daniel A. Kracov
Medical Device Congress
March 27, 2008
Key Terms (cont’d)
 Labels: Immediate container/package
 Labeling: Accompanying materials / textual relationship
 Advertising: Everything else – potential overlap
 Intended Use: Objective intent of the persons legally
responsible for the device.
– Statements, written or oral, labeling, advertising, website
– Under the Federal Food, Drug, and Cosmetic Act (FFDCA), a medical
device may be sold only for its cleared/approved intended uses.
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Key Terms (cont’d)
 Misbranding: Section 502 of the FFDCA
– false or misleading labeling
– failure to provide adequate directions for use in labeling
– failure to provide adequate warnings in labeling
– failure to include required labeling information
– failure to include relevant side effects / contraindications / warnings /
precautions in advertising (restricted devices)
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Key Terms (cont’d)
 Adulteration: Section 501(f) of the FFDCA
– No PMA for Class III device (as required by § 515)
 Prohibited Acts:
– Distribution of adulterated or misbranded medical device.
Section 301(a) of the FFDCA
– Failure to follow 510(k) requirements. Section 301(p) of the
FFDCA
 Promotion of investigational devices
– Commercialization prohibited under 21 C.F.R. § 812.7
– May not represent investigational device as safe and effective
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Key Terms
 Off-Label Use: Physician uses a medical device for a clinical
purpose not included on the product’s official labeling
 Off-Label Promotion: A device manufacturer makes
marketing claims for the product regarding a clinical use not
included in the labeling
– May make the device an unapproved device, and may otherwise
result in the misbranding and adulteration of the device
 Off-Label Education: A device manufacturer disseminates
medical literature (or underwrites continuing medical education
programs) that discuss a clinical use not included in the labeling
– “Scientific Exchange”
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Promotion for Off-Label Uses
 Adult device marketed for use in pediatric settings
 Device marketed for diagnosis rather than aid in
screening/detection
 Diagnostic marketed for broader diagnosis than labeled
 Biliary stent marketed for vascular surgery
 Device not cleared for ambulatory patients marketed for
ambulatory use
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What are the risks?
 Liability under the Federal Food, Drug, and Cosmetic Act
 Liability under the False Claims Act
 State law liability
– Attorneys General
 Liability to consumers
– Product liability
• Loss of preemption and other defenses
– Deceptive/unfair trade practices / fraud
– RICO
 Competitor liability
– Lanham Act
 Liability to shareholders and SEC
 Criminal liability due to wire fraud, obstruction, etc.
 Limitations on insurance coverage
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How far beyond the “safe harbors” is unsafe?
 Manufacturer compliance policies/risk profile vary.
Major risks
Need to look at the overall pattern of
activities and compliance system
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Areas of Risk
 Business and strategic planning documents
– ROI analyses for off-label activities
– Market research
– Publication plans
 Product development records showing decisions not to
seek FDA approval/clearance
 Tracking of off-label uses
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Areas of Risk (cont’d)
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Advisory Boards
Consultants
Reimbursement assistance
Website links and chat rooms
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Areas of Risk (cont’d)
 Grant activities
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Involvement of marketing and sales
Continuing Medical Education
“Wholly owned” grantees
Development of treatment guidelines and algorithms
Grants to state agencies and health care entities
 Comparative claims where the competitor has broader
labeling
 Success stories and testimonials stating off-label uses
 Briefings for analysts
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Areas of Risk: Sales Force
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Training materials and sales meetings
Trade show statements
“Homemade” materials
“Hands-on training” activities
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Areas of Risk: Sales Force (cont’d)
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Call notes and e-mails
Detailing to “off-label” medical specialties
Sampling patterns
Compensation systems
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“Safe Harbors” for Conveying Off-Label
Information
 Unsolicited Requests
– FDAMA, Section 557 of the FFDCA
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Must be bona fide, not cued
Responsive to scope of the request
Objective, balanced – a medical communication
Documentation of requests
Patterns suggesting solicitation
Role of Medical Affairs
Scripting of transitions to Medical Affairs
Pre-packaged response materials
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“Safe Harbors” (cont’d)
 Continuing Medical Education
– 1997 FDA Guidance (62 Fed. Reg. 64074 (Dec. 3, 1997)
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Content relating to unapproved products or off-label
Agreement with accredited provider
Independent, nonpromotional, educational
No company control over content/presenters (suggestions may be
acceptable)
Disclose funding, company relationships, unapproved products
Balance in presentation, opportunity for discussion
No sales/marketing involvement/exhibits in room
Program materials disseminated by CME provider only
Compliance record
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“Safe Harbors” (cont’d)
 Dissemination of Off-Label Journal Articles and Other
Off-Label Materials
– Washington Legal Foundation Case
• Applicability of First Amendment to medical device/pharmaceutical industry
commercial speech
• Controversy continued for many years; a series of decisions
• Ultimately inconclusive
 … but see U.S. v. Caputo
– Abtox Plazlyte hospital sterilizer
– Unsuccessful First Amendment defense to off-label marketing.
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“Safe Harbors” (cont’d)
 FDAMA Section 401
– Sunsetted
– Extremely narrow and burdensome
– Dissemination of reprints of journal articles and reference
texts discussing unapproved new uses
– Not false or misleading, or a significant risk to public health
– Target audience limited to health care practitioners,
pharmacy benefit managers, health insurance, group health
plans, federal/state agencies
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“Safe Harbors” (cont’d)
 FDAMA Section 401
(cont’d)
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presubmission of publication to FDA (60 days)
presubmission of all clinical trial information
prominent disclosure statement; bibliography
additional information; FDA objective statement
records and biannual report to FDA of all dissemination and
recipients
– submission of PMA supplement or 510(k) prior to
dissemination, or certification that supplement will be
submitted (6 mos./36 mos.)
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FDA Draft Guidance on Reprints
 Good Reprint Practices for the Distribution of Medical
Journal Articles and Medical or Scientific Reference
Publications on Unapproved New Uses of Approved
Drugs and Approved or Cleared Medical Devices
(February 2008)
– http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0053gdl.pdf
 Objection by House OGR Committee Chairman Waxman
– http://oversight.house.gov/documents/20071130102744.pdf
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Eli Lilly / Evista® (2005)
 Alleged illegal promotion of an osteoporosis drug for off-label uses
(prevention of breast cancer and cardiovascular disease)
– Traditional FDA “intended use” theory
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Prompted questions by sales force
Training of sales force in off-label uses
“Best practices” videotape
Consultant meetings
Tracking of prescriptions
 Consent Decree
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$24 million in equitable disgorgement
Criminal fine of $6 million
Forfeiture of $6 million
Corporate Integrity Agreement in an FDA Consent Decree
No exclusion
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Questions?
Daniel A. Kracov
Arnold & Porter LLP
555 Twelfth Street, N.W
Washington, D.C. 20004
(202) 942-5120 phone
(202) 942-5999 facsimile
[email protected]
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