pharmaceutical data mining

Impact of the Physician Payment Sunshine Act on State Regulations: Adoption of General Compliance Programs, Data Mining, DOJ Compliance

By on May 27, 2013 - Comments off

In addition to the gift ban laws discussed in our last series post, certain states require drug companies to adopt general compliance programs. Both Connecticut and California require drug companies to adopt such programs in accordance with the Office of Inspector General’s “Compliance Program Guidance for Pharmaceutical Manufacturers.” There are several elements in the guidance for manufacturers to consider when developing a compliance program, including:

  • Written policies;
  • Training program;
  • Designation of a compliance officer and other appropriate bodies;
  • Line of communication between all employees and compliance officer;
  • Risk evaluation to monitor compliance;
  • Policies for investigating noncompliance; and
  • Development of policies to deal with employees and entities excluded from participation in federal healthcare programs.

This legal requirement is generally not burdensome for manufacturers thanks to the autonomous nature of the laws and the broad language of the guidance.
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