fda regulation of the dissemination of medical device information daniel a. kracov medical device...
TRANSCRIPT
FDA Regulation of the Dissemination of Medical Device Information
Daniel A. Kracov
Medical Device Congress
March 27, 2008
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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)
Advisory Boards Consultants Reimbursement assistance Website links and chat rooms
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Areas of Risk (cont’d)
Grant activities– 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
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)
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
• 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)
• 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)
– 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-0053-gdl.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
• Prompted questions by sales force• Training of sales force in off-label uses• “Best practices” videotape• Consultant meetings• Tracking of prescriptions
Consent Decree– $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. KracovArnold & Porter LLP
555 Twelfth Street, N.WWashington, D.C. 20004
(202) 942-5120 phone(202) 942-5999 facsimile