Health Policy, In the News, Interpersonal Communication , , , , ,

Corporate Integrity Agreements

Throughout the summer I’ve dedicated several posts to the ways that medical and pharmaceutical publishing should be ethically conducted, according to established requirements and guidelines.

However, I’m sure it comes as no surprise that pharmaceutical companies have consistently failed to play by these rules. Headlines such as “GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data,” and “Bristol-Myers Squibb to Pay More Than $515 million to Resolve Illegal Drug Marketing and Pricing Allegations,” are proof that these companies are not always committed to high ethical standards of practice.

Although industry standards such as the ICMJE and GPP3 guidelines are almost universally accepted, they are not laws and are therefore not usually enforceable.

However, when pharmaceutical and biotech companies fall under Federal investigation, the Office of the Inspector General (OIG) can make them agree to abide by a Corporate Integrity Agreement (CIA) as part of their legal settlement.

These CIAs legally obligate companies to abide by many of the tenets of the previously mentioned guidelines and ensure ethical practice by imposing requirements such as:

  • hiring a compliance officer/appointing a compliance committee
  • developing written standards and policies
  • implementing a comprehensive employee training program
  • retaining an independent review organization (IRO) to conduct annual reviews
  • restricting employment of ineligible persons (people who have been flagged for unethical behavior)
  • providing an implementation report and annual reports to OIG on the status of compliance activities

If a company is non-compliant with their CIA, they risk having their product pulled from the list of products that can be reimbursed through Federal health care programs such as Medicare and Medicaid. This loss would be a crippling financial hit to most companies, making compliance with these agreements a high priority.
In this way, the industry can be kept in check and forced to behave in a more ethical manner.