In 2012, pharmaceutical giant GlaxoSmithKline (GSK) reached a landmark settlement with the United States government that required the company to implement a corporate integrity agreement (CIA). This agreement was designed to address various compliance issues related to the marketing and promotion of GSK`s drugs, as well as the company`s interactions with healthcare professionals.
The CIA included a number of specific requirements that GSK was required to adhere to for a period of five years. Some of the key provisions of the agreement included:
– The appointment of an independent monitor to oversee GSK`s compliance with the CIA.
– The implementation of various internal controls and procedures to ensure compliance with all applicable laws and regulations.
– The establishment of a program to monitor and evaluate the performance of sales representatives and other employees involved in the marketing and promotion of GSK`s drugs.
– The adoption of transparency measures to ensure that all of GSK`s interactions with healthcare professionals are fully disclosed and properly accounted for.
– The creation of a hotline for employees to report any potential violations of the company`s policies.
The CIA also required GSK to pay a significant financial penalty ($3 billion) to resolve various allegations of misconduct related to the marketing and promotion of its drugs. Among these allegations were claims that GSK engaged in off-label marketing (promoting drugs for uses not approved by the FDA), paid kickbacks to healthcare professionals to increase prescriptions, and failed to report safety data related to certain drugs.
The CIA represented a significant step forward in the efforts to promote transparency and integrity in the pharmaceutical industry. By requiring GSK to implement a wide range of compliance measures and pay a substantial penalty for its past behavior, the government sent a strong message that companies must take their responsibilities to patients and healthcare professionals seriously.
While the CIA was set to expire in 2017, GSK announced in 2016 that it would extend the agreement through 2020 to continue its focus on compliance and transparency. This move demonstrates a commitment to ethical behavior that will hopefully serve as an example to other companies in the industry.