Generic Medical Device Company (

1
Generic Medical Device Company (MDC)

• Avoiding Promotion of Off-Label-Use

2
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.

4
MDC Responsibilities

• MDC has the responsibility for the promotion,
  marketing and labeling of medical devices.
• The FDA may monitor MDCs practices and enforce
  regulations, when necessary.
• Enforcement could include criminal and civil
  actions.

5
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.

6
Labeling

• All medical devices distributed by MDC must
  contain the required labeling.
• On product
• On packaging
• In manuals

7
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.

8
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.

9
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.
  

10
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.

11
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.

13
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.

14
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.

15
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.

16
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.

17
Questions and Deviations

• Questions or deviations from MDC policy should be
  brought to the attention of the MDC
• CEO
• Director of Quality and/or
• Director 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.