False Claims Act settlements between pharmaceutical companies and the Department of Justice (DOJ) for off-label promotion have been in the news lately. Off-label promotion occurs when a pharmaceutical company promotes an FDA approved drug for a use that is not listed on the drug’s approved prescribing information. When federal health benefits plans pay for the drugs associated with this off-label use, a potential false claim results.
As a part of these settlement agreements, pharma companies agree to implement rigorous training programs for their employees and for their contractors. Universities, such as Emory, which perform clinical trials for pharma companies typically fall within the scope of these settlement training provisions. As a result, Emory has been asked to certify to the government that Emory employees involved in the clinical trials have completed the required training. To implement this requirement, Emory must analyze its clinical trials agreements to determine which come within the scope of a settlement. Once those contracts are identified, Emory must then determine which employees associated with the contract must be trained and then insure that the training is completed. As new employees come on board, Emory must ensure that they complete any training requirements as well. This is a time-consuming task for which the pharma companies, to date, have provided little support. Accordingly, Emory will be exploring possible contracting options that call for pharma companies to identify contracts subject to settlements and to provide compensation for the administrative work that Emory provides in relation to the settlements.