UCB, a multinational biopharmaceutical company, has been under a Corporate Integrity Agreement (CIA) since 2015. The CIA was implemented by the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) after UCB was found to have violated the False Claims Act.
The False Claims Act prohibits companies from knowingly submitting false or fraudulent claims for payment to the federal government. In UCB`s case, they were accused of promoting and marketing their drug, Keppra, for off-label uses. Off-label use refers to the use of a drug for purposes other than those approved by the US Food and Drug Administration (FDA).
Under the terms of the CIA, UCB agreed to implement various measures to ensure compliance with federal healthcare program requirements and to prevent future violations. These measures include:
– Establishing a compliance committee and appointing a compliance officer
– Conducting regular training for UCB employees on the requirements of federal healthcare programs and the company`s policies and procedures
– Conducting annual audits of the company`s compliance program and reporting the results to the OIG
– Maintaining accurate records of all promotional and marketing activities
– Prohibiting the use of financial incentives for off-label promotion
– Implementing a process for reviewing and approving promotional materials
The CIA also requires UCB to engage an independent review organization to assess the effectiveness of the company`s compliance program and to submit annual reports to the OIG.
Compliance with the CIA is crucial for UCB to maintain its reputation and avoid further legal consequences. The company has stated its commitment to adhering to the CIA and promoting ethical behavior within the organization.
In conclusion, the UCB Corporate Integrity Agreement is a significant step towards ensuring compliance with federal healthcare program requirements and preventing future violations. The implementation of various measures, including the establishment of a compliance committee and regular training for employees, will help promote ethical behavior within the company. Compliance with the CIA is essential for UCB to maintain its reputation and avoid further legal consequences.