FDA Regulation of the Dissemination of Medical Device Information Daniel A. Kracov Medical Device Congress March 27, 2008 - PowerPoint PPT Presentation


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FDA Regulation of the Dissemination of Medical Device Information Daniel A. Kracov Medical Device Congress March 27, 2008


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Title: FDA Regulation of the Dissemination of Medical Device Information Daniel A. Kracov Medical Device Congress March 27, 2008

FDA Regulation of the Dissemination of
Medical Device Information Daniel A.
Kracov Medical Device Congress March
27, 2008
Key Terms (contd)
  • Labels Immediate container/package
  • Labeling Accompanying materials / textual
  • 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.

Key Terms (contd)
  • Misbranding Section 502 of the FFDCA
  • false or misleading labeling
  • failure to provide adequate directions for use in
  • 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)

Key Terms (contd)
  • Adulteration Section 501(f) of the FFDCA
  • No PMA for Class III device (as required by
  • 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.
  • May not represent investigational device as safe
    and effective

Key Terms
  • Off-Label Use Physician uses a medical device
    for a clinical purpose not included on the
    products 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
  • Scientific Exchange

Promotion for Off-Label Uses
  • Adult device marketed for use in pediatric
  • Device marketed for diagnosis rather than aid in
  • Diagnostic marketed for broader diagnosis than
  • Biliary stent marketed for vascular surgery
  • Device not cleared for ambulatory patients
    marketed for ambulatory use

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

How far beyond the safe harbors is unsafe?
  • Manufacturer compliance policies/risk profile
  • Major risks
  • Need to look at the overall pattern of activities
    and compliance system

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

Areas of Risk (contd)
  • Advisory Boards
  • Consultants
  • Reimbursement assistance
  • Website links and chat rooms

Areas of Risk (contd)
  • Grant activities
  • Involvement of marketing and sales
  • Continuing Medical Education
  • Wholly owned grantees
  • Development of treatment guidelines and
  • 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

Areas of Risk Sales Force
  • Training materials and sales meetings
  • Trade show statements
  • Homemade materials
  • Hands-on training activities

Areas of Risk Sales Force (contd)
  • Call notes and e-mails
  • Detailing to off-label medical specialties
  • Sampling patterns
  • Compensation systems

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

Safe Harbors (contd)
  • Continuing Medical Education
  • 1997 FDA Guidance (62 Fed. Reg. 64074 (Dec. 3,
  • Content relating to unapproved products or
  • 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
  • No sales/marketing involvement/exhibits in room
  • Program materials disseminated by CME provider
  • Compliance record

Safe Harbors (contd)
  • 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
  • Ultimately inconclusive
  • but see U.S. v. Caputo
  • Abtox Plazlyte hospital sterilizer
  • Unsuccessful First Amendment defense to off-label

Safe Harbors (contd)
  • 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

Safe Harbors (contd)
  • FDAMA Section 401 (contd)
  • 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.)

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-0
  • Objection by House OGR Committee Chairman Waxman
  • http//oversight.house.gov/documents/2007113010274

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
  • No exclusion

Questions? Daniel A. Kracov Arnold Porter
LLP 555 Twelfth Street, N.W Washington, D.C.
20004 (202) 942-5120 phone (202) 942-5999
facsimile Daniel.Kracov_at_aporter.com
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