Who negotiates CIAs with pharmaceutical companies?

The negotiation of Corporate Integrity Agreements (CIAs) with pharmaceutical companies is primarily the responsibility of the Office of Inspector General (OIG). CIAs are designed to promote compliance with federal healthcare program requirements and to ensure that the companies adhere to regulations, particularly in relation to ethical practices and transparency. When a pharmaceutical company has been found to have engaged in fraudulent activities or violations of healthcare laws, the OIG steps in to negotiate these agreements. They often outline specific compliance measures that the company must implement over a set period to avoid further penalties.

The Department of Health and Human Services, the Food and Drug Administration, and the Centers for Disease Control and Prevention focus on different aspects of public health, regulation, and disease control and are not involved in the negotiation of CIAs. The OIG serves a distinct role in overseeing healthcare integrity and enforcing compliance, making it the appropriate entity for this responsibility.