Generic Medical Device Company (“MDC”)

Generic Medical Device Company (“MDC”) Avoiding Promotion of “Off-Label-Use” Dickson Consulting

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. Dickson Consulting

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. Dickson Consulting

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. Dickson Consulting

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. Dickson Consulting

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

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. Dickson Consulting

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. Dickson Consulting

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. Dickson Consulting

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. Dickson Consulting

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. Dickson Consulting

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. Dickson Consulting

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. Dickson Consulting

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. Dickson Consulting

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. Dickson Consulting

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. Dickson Consulting

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. Dickson Consulting

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. Dickson Consulting

Generic Medical Device Company (“MDC”)