Presentation on theme: "FDA Regulation of the Dissemination of Medical Device Information"— Presentation transcript:
1 FDA Regulation of the Dissemination of Medical Device Information FDA Regulation of the Dissemination of Medical Device Information Daniel A. Kracov Medical Device Congress March 27, 2008
2 Key Terms (cont’d) Labels: Immediate container/package Labeling: Accompanying materials / textual relationshipAdvertising: Everything else – potential overlapIntended Use: Objective intent of the persons legally responsible for the device.Statements, written or oral, labeling, advertising, websiteUnder the Federal Food, Drug, and Cosmetic Act (FFDCA), a medical device may be sold only for its cleared/approved intended uses.
3 Key Terms (cont’d) Misbranding: Section 502 of the FFDCA false or misleading labelingfailure to provide adequate directions for use in labelingfailure to provide adequate warnings in labelingfailure to include required labeling informationfailure to include relevant side effects / contraindications / warnings / precautions in advertising (restricted devices)
4 Adulteration: Section 501(f) of the FFDCA Prohibited Acts: Key Terms (cont’d)Adulteration: Section 501(f) of the FFDCANo PMA for Class III device (as required by § 515)Prohibited Acts:Distribution of adulterated or misbranded medical device. Section 301(a) of the FFDCAFailure to follow 510(k) requirements. Section 301(p) of the FFDCAPromotion of investigational devicesCommercialization prohibited under 21 C.F.R. § 812.7May not represent investigational device as safe and effective
5 Key TermsOff-Label Use: Physician uses a medical device for a clinical purpose not included on the product’s official labelingOff-Label Promotion: A device manufacturer makes marketing claims for the product regarding a clinical use not included in the labelingMay make the device an unapproved device, and may otherwise result in the misbranding and adulteration of the deviceOff-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”
6 Promotion for Off-Label Uses Adult device marketed for use in pediatric settingsDevice marketed for diagnosis rather than aid in screening/detectionDiagnostic marketed for broader diagnosis than labeledBiliary stent marketed for vascular surgeryDevice not cleared for ambulatory patients marketed for ambulatory use
7 What are the risks?Liability under the Federal Food, Drug, and Cosmetic ActLiability under the False Claims ActState law liabilityAttorneys GeneralLiability to consumersProduct liabilityLoss of preemption and other defensesDeceptive/unfair trade practices / fraudRICOCompetitor liabilityLanham ActLiability to shareholders and SECCriminal liability due to wire fraud, obstruction, etc.Limitations on insurance coverage
8 How far beyond the “safe harbors” is unsafe? Manufacturer compliance policies/risk profile vary.Major risksNeed to look at the overall pattern of activities and compliance system
9 Areas of Risk Business and strategic planning documents ROI analyses for off-label activitiesMarket researchPublication plansProduct development records showing decisions not to seek FDA approval/clearanceTracking of off-label uses
10 Areas of Risk (cont’d) Advisory Boards Consultants Reimbursement assistanceWebsite links and chat rooms
11 Areas of Risk (cont’d) Grant activities Involvement of marketing and salesContinuing Medical Education“Wholly owned” granteesDevelopment of treatment guidelines and algorithmsGrants to state agencies and health care entitiesComparative claims where the competitor has broader labelingSuccess stories and testimonials stating off-label usesBriefings for analysts
12 Areas of Risk: Sales Force Training materials and sales meetingsTrade show statements“Homemade” materials“Hands-on training” activities
13 Areas of Risk: Sales Force (cont’d) Call notes and sDetailing to “off-label” medical specialtiesSampling patternsCompensation systems
14 “Safe Harbors” for Conveying Off-Label Information Unsolicited RequestsFDAMA, Section 557 of the FFDCAMust be bona fide, not cuedResponsive to scope of the requestObjective, balanced – a medical communicationDocumentation of requestsPatterns suggesting solicitationRole of Medical AffairsScripting of transitions to Medical AffairsPre-packaged response materials
15 “Safe Harbors” (cont’d) Continuing Medical Education1997 FDA Guidance (62 Fed. Reg (Dec. 3, 1997)Content relating to unapproved products or off-labelAgreement with accredited providerIndependent, nonpromotional, educationalNo company control over content/presenters (suggestions may be acceptable)Disclose funding, company relationships, unapproved productsBalance in presentation, opportunity for discussionNo sales/marketing involvement/exhibits in roomProgram materials disseminated by CME provider onlyCompliance record
16 “Safe Harbors” (cont’d) Dissemination of Off-Label Journal Articles and Other Off-Label MaterialsWashington Legal Foundation CaseApplicability of First Amendment to medical device/pharmaceutical industry commercial speechControversy continued for many years; a series of decisionsUltimately inconclusive… but see U.S. v. CaputoAbtox Plazlyte hospital sterilizerUnsuccessful First Amendment defense to off-label marketing.
17 “Safe Harbors” (cont’d) FDAMA Section 401SunsettedExtremely narrow and burdensomeDissemination of reprints of journal articles and reference texts discussing unapproved new usesNot false or misleading, or a significant risk to public healthTarget audience limited to health care practitioners, pharmacy benefit managers, health insurance, group health plans, federal/state agencies
18 “Safe Harbors” (cont’d) FDAMA Section 401 (cont’d)presubmission of publication to FDA (60 days)presubmission of all clinical trial informationprominent disclosure statement; bibliographyadditional information; FDA objective statementrecords and biannual report to FDA of all dissemination and recipientssubmission of PMA supplement or 510(k) prior to dissemination, or certification that supplement will be submitted (6 mos./36 mos.)
19 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)Objection by House OGR Committee Chairman Waxman
20 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” theoryPrompted questions by sales forceTraining of sales force in off-label uses“Best practices” videotapeConsultant meetingsTracking of prescriptionsConsent Decree$24 million in equitable disgorgementCriminal fine of $6 millionForfeiture of $6 millionCorporate Integrity Agreement in an FDA Consent DecreeNo exclusion
21 Questions. Daniel A. Kracov Arnold & Porter LLP 555 Twelfth Street, N Questions? Daniel A. Kracov Arnold & Porter LLP 555 Twelfth Street, N.W Washington, D.C (202) phone (202) facsimile
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