Tips to Avoid Off-label Promotion


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

Published in: Business, Health & Medicine
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Tips to Avoid Off-label Promotion

  1. 1. Generic Medical Device Company (“Company”) <ul><li>Avoiding Promotion of “Off-Label-Use” </li></ul>
  2. 2. Off-Label Usage <ul><li>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. </li></ul><ul><li>Important distinction between promotion of a device by a company and use of a device by a doctor. </li></ul>
  3. 3. InterMune Example of An Off-Label Case <ul><li>Alleged off-label promotion and marketing of drug from August 2002 to January 2003. </li></ul><ul><li>Two-year investigation by the Department of Justice, the U.S. Attorney’s Office, and the FDA Office of General Counsel. </li></ul><ul><li>Settlement includes: </li></ul><ul><ul><li>Civil Settlement Agreement </li></ul></ul><ul><ul><li>Corporate Integrity Agreement </li></ul></ul><ul><ul><li>Deferred Prosecution Agreement </li></ul></ul><ul><li>Financial settlement-$36.9 million plus 5% interest payable to the government over five years. </li></ul>
  4. 4. Schering-Plough Example of An Off-Label Case <ul><li>U. S. Department of Justice investigation into sales, marketing and clinical trail practices and programs. The government claimed: </li></ul><ul><ul><li>Schering salespeople were trained how to win off-label sales and were paid for doing so. </li></ul></ul><ul><ul><li>Tactics included &quot;illegal remuneration&quot; to doctors for &quot;sham advisory boards&quot; and &quot;lavish entertainment“. </li></ul></ul><ul><li>Aggregate settlement amount of $435 million: </li></ul><ul><ul><li>One count of conspiracy to make false statements to the government. Criminal fine of $180 million. </li></ul></ul><ul><ul><li>$225 million to resolve civil aspects of the investigation. </li></ul></ul><ul><li>Schering required to sign an addendum to an existing corporate integrity agreement. </li></ul>
  5. 5. C ompany Responsibilities <ul><li>Company has the responsibility for the promotion, marketing and labeling of medical devices. </li></ul><ul><li>The FDA may monitor company’s practices and enforce regulations, when necessary. </li></ul><ul><li>Enforcement could include criminal and civil actions. </li></ul>
  6. 6. Physicians Decisions <ul><li>A physician may refer or use a device for off-label usage, if the intent of the use falls under the “practice of medicine”. </li></ul><ul><li>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. </li></ul>
  7. 7. Labeling <ul><li>All medical devices distributed by company must contain the required labeling. </li></ul><ul><ul><li>On product </li></ul></ul><ul><ul><li>On packaging </li></ul></ul><ul><ul><li>In manuals </li></ul></ul>
  8. 8. Product Nomenclature <ul><li>The company medical device may fit into a specific product description used by the FDA. </li></ul><ul><li>Company personnel should not refer to the medical device by nomenclature other than that used by the FDA. </li></ul><ul><li>It is recognized that individuals not employed by the company may refer to the device with nomenclature different than that used by the FDA. </li></ul>
  9. 9. Indications for Use <ul><li>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. </li></ul>
  10. 10. Sales Efforts <ul><li>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. </li></ul><ul><li>Sales training and meetings should only address indications that are approved for use by the FDA. </li></ul>
  11. 11. Promotional Materials <ul><li>Promotional materials should be limited to the indications for use for which the device has been approved by the FDA. </li></ul><ul><li>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). </li></ul>
  12. 12. Promotional Materials Disclaimers <ul><li>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: </li></ul><ul><ul><li>Is for investigational purposes only. </li></ul></ul><ul><ul><li>Has not been approved by the FDA. </li></ul></ul>
  13. 13. Distribution of Journal Articles Or Reference Texts <ul><li>Request should be unsolicited. </li></ul><ul><li>Should have centralized control over distribution. </li></ul><ul><li>Information must be fair and balanced. </li></ul><ul><li>Fulfillment log should be maintained which includes: </li></ul><ul><ul><li>Identity of requestor </li></ul></ul><ul><ul><li>Date of request </li></ul></ul><ul><ul><li>Substance of the request </li></ul></ul><ul><ul><li>Date of the response </li></ul></ul><ul><ul><li>Material provided in response to the request </li></ul></ul>
  14. 14. Clinical Papers <ul><li>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. </li></ul><ul><li>All such papers must: </li></ul><ul><ul><li>Be clearly marked “This information concerns a use that has not been approved or cleared by the FDA”. </li></ul></ul><ul><ul><li>Must include approved labeling. </li></ul></ul><ul><ul><li>Contain a bibliography of other articles relating to the new use. </li></ul></ul>
  15. 15. Clinical Paper Criteria <ul><li>Form is: </li></ul><ul><ul><li>Unabridged reprint </li></ul></ul><ul><ul><li>Copy of peer-reviewed scientific or medical journal </li></ul></ul><ul><ul><li>Unabridged reference journal </li></ul></ul><ul><li>Content about clinical investigation that is considered scientifically sound by qualified experts. </li></ul><ul><li>The use does not pose a significant risk to the public health. </li></ul><ul><li>Paper is not false or misleading. </li></ul><ul><li>Information is not derived without permission from clinical research conducted by another manufacturer. </li></ul>
  16. 16. Press Releases <ul><li>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. </li></ul><ul><li>Company should not instigate or induce issuance of press releases that discuss off-label use. </li></ul>
  17. 17. Special Products <ul><li>Devices specifically for an off-label use should not be assembled or distributed by the company to promote off-label use. </li></ul><ul><li>The medical devices must not be specifically distributed by the company for a use for which it has not received FDA approval. </li></ul>
  18. 18. Internal Correspondence <ul><li>Internal emails or other internal correspondence should not promote products for off-label use. </li></ul><ul><li>Company internal documents that discuss or relate to any off-label use(s) cannot be distributed to individuals outside of the company. </li></ul>
  19. 19. Questions and Deviations <ul><li>Questions or deviations from policy should be brought to the attention of the company: </li></ul><ul><ul><li>CEO </li></ul></ul><ul><ul><li>Director of Quality and/or </li></ul></ul><ul><ul><li>Director of Clinical Affairs </li></ul></ul><ul><ul><li>Director of Marketing </li></ul></ul><ul><ul><li>Other?? </li></ul></ul>
  20. 20. Disclaimers <ul><li>The information in this presentation is believed to be correct but no assurances are provided that the information is correct. </li></ul><ul><li>Issues may exist that are significant that are not mentioned in this report. </li></ul><ul><li>This information is not intended to provide legal advice. </li></ul>