Company Responsibilities
Company has the responsibility for promotion, marketing and labelling of medical device. The FDA many monitor company’s practices and enforce regulations when necessary. enforcement may include criminal and civil actions
Labelling
All medical devices distributed by company must contain the required labeling On product ,On packaging and 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
Sales Effort
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.
Example of off label promotion cases
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