Purdue Pharma’s Road to Ethical Misconduct

Purdue Pharma and its branches create and give physician endorsed prescriptions that meet the developing needs of healthcare experts, patients, and companion care providers. Purdue Pharma were established by doctors and are right now driven by a medical doctor. Part of their endeavors to give quality prescriptions, Purdue Pharma was focused on supporting national, state and local coordinated efforts to drive developments in patient care consideration while likewise proceeding with their endeavors to address the narcotic epidemic.

Purdue Pharma created Imbrium Therapeutics L.P. to additionally increase its rising portfolio and build up its pipeline in the territories of CNS, non-narcotic drugs, and select oncology through inside research, key joint efforts and associations. Purdue’s branches additionally incorporate Adlon Therapeutics L.P., concentrated on treatment for Attention Deficit/Hyperactivity Disorder (ADHD) and related issue, and Greenfield Bioventures, a speculation vehicle concentrated on esteem articulation in the inception of clinical improvement.

Purdue Pharma Purpose Statement and Values are what set the moral standard upon. Purdue Pharma Purpose Statement States compassion for patients and excellence in science inspire our pursuit of new medicines. (See Exhibit 1.1 ) Also, Purdue Pharma Integrity Statement States we do what is right. Purdue Pharma Courage Statement States we challenge convention and embrace change. Purdue Pharma Innovation Statement States we apply creative and agile thinking to generate solutions. Also, Purdue Pharma Statement states we work together to meet our commitments and goals.

Purdue Pharma Code of Ethics Statement of ethical and compliance principles guiding their daily operations. The Code of Ethics establishes their expectation that management, employees, and agents act in accordance with all laws, regulations, and policies. Also, The Code of Ethics articulates their fundamental purpose and values, providing a framework for action within their organization. 

The Summary of the Ethics and Compliance Program Consists of Leadership and Structure, Written Standards, Education and Training, Internal Lines of Communication, Auditing and Monitoring, Responding to Potential Violations and Corrective Action Procedures. The Leadership and Structure position consists of the Vice-President, Ethics, & Compliance and the Compliance Committees. The Vice-President, Ethics, & Compliance is Margaret K. Felts who is the point of contact for ethics and compliance issues. Ms. Felts duty is to develop, operate and monitor The Ethics & Compliance Program. Also, The Vice-President, Ethics, & Compliance’s position is overseen by the Purdue’s General Counsel, a member of the Purdue’s Executive Committee, and has direct communication to both Purdue Pharma L.P.’s Chief Executive Officer and the Purdue Pharma L.P. Board of Directors.  

The Compliance Committees consists of Sales & Marketing, Medical Affairs, Enterprise and Compliance and Risk Management Council and to counsel the Vice-President, Ethics & Compliance and Risk Management Council to contribute to the implementation of the Ethics & Compliance Program. Also, The Compliance Committees work with other departments to identify risk management issues of the organization.

Ethical Misconduct is reported through internal lines of communication as a means of requesting open communication between management and employees. Also, Purdue Pharma’s Code Violation Policy for employees should be done without fear of retaliation.  Purdue Pharma has a confidential, Toll-free Integrity Hotline (1-877-PURDUE1) where internal and external individuals for their organization may report any unethical conduct of law, regulation and policy.

When Purdue Pharma started selling its medicine opioid medication OxyContin in 1996. Dr. Richard Sackler asked people gathered for the launch party to envision natural disasters. (Joseph, 2019)  OxyContin was introduced, said Dr. Richard Sackler, a member of the family that operates and controls the company, and then an organization, will be followed by a storm of prescriptions that will bury the competition.(Joseph, 2019)  After five years, as questions were raised about the risks of addictions and overdoses that came with taking OxyContin and opioid medication. Sackler implemented a strategy that critics long accused the company of unleashing: divert the blame onto others, particularly the people who become addicted to opioids themselves. (Joseph, 2019).

 On March 26, 2019, The State of Oklahoma was first of in excess of 1,600 claims pending against Purdue Pharma, the creator of the narcotic OxyContin, has been settled. (Bebinger, 2019) The drug maker has consented to pay $270 million to support addiction research and treatment in Oklahoma and pay lawful expenses. BOklahoma Attorney General Mike Hunter documented suit two years back charging Purdue touched off the narcotic epidemic with forceful showcasing of the blockbuster medication OxyContin and cases that made light of the risks of addiction.

I believe the Purdue Pharma Ethical Structure has a good structure and could have avoided some of the ethical misconduct if the Ethics and Compliance Policy was properly executed. The Purdue Pharma Leadership (Vice President Ethics and Compliance and Sales & Marketing Committee did not follow the Ethics and Compliance Program Policy for violations of law, regulations and policies and was deemed ineffective. Also, the Overseers of the Vice President of Ethics and Compliance and Sales and the Marketing Committee should be held accountable for not following Purdue Pharma’s Ethics and Compliance Policy. Furthermore, I believe Purdue Pharma should hire an outside independent regulatory agency to oversee their Ethics and Compliance Program to ensure this program is being implemented effectively within the company.

PURDUE PHARMA

ETHICS MANAGEMENT INFRASTRUCTURE

Exhibit 1.1

References:

• https://purduepharma.com/about/#&panel1-36
• Joseph, A. (2019, January 15). ‘A Blizzard of Prescriptions’: Documents Reveal New Details About Purdue’s Marketing of OxyContin. Retrieved from https://www.statnews.com/2019/01/15/massachusetts-purdue-lawsuit-new-details/
• Bebinger, B. (2019, March 23). Purdue Pharma Agrees To $270 Million Opioid Settlement With Oklahoma. Retrieved from https://www.npr.org/sections/health-shots/2019/03/26/706848006/purdue-pharma-agrees-to-270-million-opioid-settlement-with-oklahoma

CONCLUSION

The Purdue Pharma Audit found that leadership control procedure for the Code of Ethics is being followed and performing as intended, with the following:

• Yearly reminders with acknowledgement confirmations could be sent to employees to remind them of the requirements of the Code of Ethics for Purdue Pharma.
• the Ethics & Compliance Program processes should be reviewed to ensure the confidential Report process meets the Purdue Pharma Code of Ethics requirements;
• Based on the risks with pharmaceutical contracts, including marketing contracts attention should be given to the requirements of the Ethics and Compliance Standards.
• the Purdue Pharma Compliance Committees should conduct an ethical risk assessment to serve as the basis for planning and management activities; and provide input to the Vice -President Ethics & Compliance detailing the Ethic and Compliance process.
• The Vice-President Ethics & Compliance should also ensure that all department wide, ethical climate survey is conducted; and a leadership action plan is developed and actioned to address the results of the unfavorable ethical conduct.

RECOMMENDATIONS FOR IMPROVING ETHICAL BEHAVIOR FOR PURDUE PHARMA

• Recommendation #1

The Vice President of Ethics & Compliance should ensure the distribution of a yearly reminder to all employees regarding the requirements of the Code of Ethics.

• Recommendation #2

The Vice-President of Ethics & Compliance, Compliance Committees and Human Resources Management should review the employee Conflict of Interest processes to ensure the Confidential Report process meets the Code of Ethics requirements and to ensure that the processes are widely known by all employees.

• Recommendation #3

The Purdue Pharma’s Compliance Committees should examine whether, based on the risk with all contracts, specific attention should be drawn to the requirements of the Ethics & Compliance Program Standards.

• Recommendation #4

The Vice-President of Ethics & Compliance, Compliance Committees and Human Resources Management should implement a more formal training process such as a coaching/mentoring program for Purdue Pharma with a specific focus on ethical leadership and ethical decision making.