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Generic Medical Device Company (“MDC”)

Avoiding Promotion of “Off-Label-Use”

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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“.

• Schering required to sign an addendum to an existing corporate integrity agreement.

• 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.

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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 (“MDC”) and use of a device by a doctor.

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MDC Responsibilities

• MDC has the responsibility for the promotion, marketing and labeling of medical devices.

• The FDA may monitor MDC’s practices and enforce regulations, when necessary.

• Enforcement could include criminal and civil actions.

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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.

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Labeling• All medical devices distributed by MDC

must contain the required labeling. On productOn packagingIn manuals

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Product Nomenclature• The MDC medical device may fit into a specific

product description used by the FDA.

• MDC personnel should not refer to the MDC medical device by nomenclature other than that used by the FDA.

• It is recognized that individuals not employed by MDC may refer to the MDC device with nomenclature different than that used by the FDA.

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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 MDC personnel.

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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.

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Promotional Materials Restrictions

• Promotional materials should be limited to the indications for use or intended 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 MDC, e.g., press releases, videos, descriptions or pictures of procedures developed by MDC.

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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.

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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 MDC 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.

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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.

• Paper is not false or misleading.

• Information is not derived without permission from clinical research conducted by another manufacturer.

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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 MDC.

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Special Products

• Devices specifically for an off-label use should not be assembled or distributed by MDC to promote off-label use.

• The medical devices must not be specifically distributed by MDC for a use for which it has not received FDA approval.

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Internal Correspondence

• Internal emails or other internal correspondence should not promote products for off-label use.

• MDC internal documents that discuss or relate to any off-label use(s) cannot be distributed to individuals outside of MDC.

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Questions and Deviations

• Questions or deviations from MDC policy should be brought to the attention of the MDC:CEODirector of Quality and/orDirector of Clinical Affairs.

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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.