M e d i c i n e A v e 2 device to the FDA. One case included the charge of submitting false information to the FDA in a response to an enforcement letter. Another example involved claims that a company sold drugs at a significant discount, and then concealed the discounts to avoid paying millions of dollars in rebates to Medicaid. Yet another case alleged a pricing scheme and sales and marketing misconduct that led to reimbursement claims being submitted for products that were originally provided as free samples. Settlements for cases that may have focused initially on just one product have been broadened to include the sales and promotion activities for other products from the same company. Other settlements have involved an FDA consent decree, or a deferred prosecution agreement—an agreement whereby prosecutors seek to secure cooperation and changes in corporate behavior through increased leverage and court participation. Government prosecutors have said that companies that cooperate fully in an investigation and proactively work with government officials may receive lesser financial penalties than companies that fail to cooperate. Moreover, the passage of time is not necessarily an indication that a company's past misconduct will remain buried in the past. While the statute of limitations for the False Claims Act is six years, the government has employed other statutes to look back seven years or more and launch enforcement actions. The costs of settlements in terms of money and reputation have made it necessary for pharmaceutical, biologies and medical devices companies to rapidly adapt their business practices in response to the government's enforcement initiatives. The regulated industries have moved quickly to adopt voluntary guidelines that have redefined the relationship between companies, doctors and 48
RkJQdWJsaXNoZXIy NDMwNDAx