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Tips to Avoid Off-label Promotion

Tips to Avoid Off-label Promotion



Presentation addresses legal and regulatory issues associated with off-label promotion of medical devices.

Presentation addresses legal and regulatory issues associated with off-label promotion of medical devices.



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    Tips to Avoid Off-label Promotion Tips to Avoid Off-label Promotion Presentation Transcript

    • Generic Medical Device Company (“Company”)
      • Avoiding Promotion of “Off-Label-Use”
    • Off-Label Usage
      • Off-label use = the use of a medical device for an indication not approved by the Food & Drug Administration, i.e. not in the labeling approved by the FDA.
      • Important distinction between promotion of a device by a company and use of a device by a doctor.
    • InterMune Example of An Off-Label Case
      • Alleged off-label promotion and marketing of drug from August 2002 to January 2003.
      • Two-year investigation by the Department of Justice, the U.S. Attorney’s Office, and the FDA Office of General Counsel.
      • Settlement includes:
        • Civil Settlement Agreement
        • Corporate Integrity Agreement
        • Deferred Prosecution Agreement
      • Financial settlement-$36.9 million plus 5% interest payable to the government over five years.
    • Schering-Plough Example of An Off-Label Case
      • U. S. Department of Justice investigation into sales, marketing and clinical trail practices and programs. The government claimed:
        • Schering salespeople were trained how to win off-label sales and were paid for doing so.
        • Tactics included "illegal remuneration" to doctors for "sham advisory boards" and "lavish entertainment“.
      • Aggregate settlement amount of $435 million:
        • One count of conspiracy to make false statements to the government. Criminal fine of $180 million.
        • $225 million to resolve civil aspects of the investigation.
      • Schering required to sign an addendum to an existing corporate integrity agreement.
    • C ompany Responsibilities
      • Company has the responsibility for the promotion, marketing and labeling of medical devices.
      • The FDA may monitor company’s practices and enforce regulations, when necessary.
      • Enforcement could include criminal and civil actions.
    • Physicians Decisions
      • A physician may refer or use a device for off-label usage, if the intent of the use falls under the “practice of medicine”.
      • The submission of an Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB) is not required if use is based on a physician decision.
    • Labeling
      • All medical devices distributed by company must contain the required labeling.
        • On product
        • On packaging
        • In manuals
    • Product Nomenclature
      • The company medical device may fit into a specific product description used by the FDA.
      • Company personnel should not refer to the medical device by nomenclature other than that used by the FDA.
      • It is recognized that individuals not employed by the company may refer to the device with nomenclature different than that used by the FDA.
    • Indications for Use
      • The current labeling requirements and indications for use approved by the FDA should be well understood by all executive, sales, clinical and other key company personnel.
    • Sales Efforts
      • Efforts of sales personnel should focus on market opportunities, potential customers and physicians who will utilize the medical device for indications that are approved for use by the FDA.
      • Sales training and meetings should only address indications that are approved for use by the FDA.
    • Promotional Materials
      • Promotional materials should be limited to the indications for use for which the device has been approved by the FDA.
      • It is generally not acceptable to discuss or describe any off-label uses of the device in documents or advertising and promotional materials distributed by company ( e.g., press releases, videos, descriptions or pictures of procedures developed by the company).
    • Promotional Materials Disclaimers
      • If an off-label use needs to be mentioned in promotional materials (e.g., a press release that lists clinical papers being presented), the off-label use must be accompanied by wording that clearly states that the off-label use:
        • Is for investigational purposes only.
        • Has not been approved by the FDA.
    • Distribution of Journal Articles Or Reference Texts
      • Request should be unsolicited.
      • Should have centralized control over distribution.
      • Information must be fair and balanced.
      • Fulfillment log should be maintained which includes:
        • Identity of requestor
        • Date of request
        • Substance of the request
        • Date of the response
        • Material provided in response to the request
    • Clinical Papers
      • If an off-label use of the device is described in a paper written by a clinical investigator(s), the paper may be distributed by the company only if it is provided in its entirety.
      • All such papers must:
        • Be clearly marked “This information concerns a use that has not been approved or cleared by the FDA”.
        • Must include approved labeling.
        • Contain a bibliography of other articles relating to the new use.
    • Clinical Paper Criteria
      • Form is:
        • Unabridged reprint
        • Copy of peer-reviewed scientific or medical journal
        • Unabridged reference journal
      • Content about clinical investigation that is considered scientifically sound by qualified experts.
      • The use does not pose a significant risk to the public health.
      • Paper is not false or misleading.
      • Information is not derived without permission from clinical research conducted by another manufacturer.
    • Press Releases
      • Press releases issued by clinical institutions or investigators regarding off-label uses must not include statements or endorsements of the off-label use by anyone from the company.
      • Company should not instigate or induce issuance of press releases that discuss off-label use.
    • Special Products
      • Devices specifically for an off-label use should not be assembled or distributed by the company to promote off-label use.
      • The medical devices must not be specifically distributed by the company for a use for which it has not received FDA approval.
    • Internal Correspondence
      • Internal emails or other internal correspondence should not promote products for off-label use.
      • Company internal documents that discuss or relate to any off-label use(s) cannot be distributed to individuals outside of the company.
    • Questions and Deviations
      • Questions or deviations from policy should be brought to the attention of the company:
        • CEO
        • Director of Quality and/or
        • Director of Clinical Affairs
        • Director of Marketing
        • Other??
    • Disclaimers
      • The information in this presentation is believed to be correct but no assurances are provided that the information is correct.
      • Issues may exist that are significant that are not mentioned in this report.
      • This information is not intended to provide legal advice.