Chapter 6 CRISIS MANAGEMENT

Introduction - Crisis: ◦is a situation that specifically involves a pharmaceutical product, medical device or activity with potentially significant adverse implications for regulatory agencies, healthcare providers, patients, media, the public or external and/or internal company stakeholders. ◦situation can involve a drug or device in either the investigational phase or the marketed phase.

Examples of an Investigational Pharmaceutical or Device-Related Crisis investigator or employee fraud development program discontinuation due to safety concerns use of an investigational product outside IND requirements promotion of an investigational product Clinical Hold refusal to file an application Health Authority review issues affecting product approval pre-inspection issues

Examples of a Marketed Product-Related Crisis reports of serious adverse drug or device events or safety findings that may affect the product’s benefit:risk evaluation reports of serious adverse drug or device events or safety findings of a similar product or similar disease drug/device shortages reports of tampering product recall litigation reports and discovery activities off-label promotion inspection issue Warning Letter regulatory or political actions social media events Application Integrity Policy Corporate Integrity Agreement

Crisis Management - The mission of any Health Authority is to protect the public health and to ensure the safety, effectiveness and security of regulated products. - In any crisis, the regulatory environment needs to be understood. ◦Are there specific safety issues for which the Health Authority is watching? ◦Have there been multiple occurrences of similar issues and the agencies are now enforcing stricter consequences? ◦Are the authorities looking for reasons to support their own agendas? - Consideration also must be given to the marketplace environment. ◦Are there reimbursement issues? ◦Are there competitor issues? ◦What are the expectations of the marketplace?

Internal Management of a Crisis - Crisis Management Team (CMT) should be put into place - The focus should first be on identifying the causative issue, ensuring it is specifically defined, and how and when it occurred are determined. - The situation should be assessed to determine whether the issue is isolated, whether it has occurred with other products, or whether it could happen again.

Continued - CMT therefore must convene strategic planning meetings to put together a plan to: identify the issue and understand the fundamental concerns determine the root cause ask whether it is an isolated incident, has occurred with other products or could happen again prepare a gap analysis and potential mitigations assess applicability to other operations or products determine frequency of event identify the significance of the risk and who or what it impacts evaluate impact for other geographic regions, as applicable engage other experts as necessary, to assist in problem-solving define activities, solutions, resources and timelines in a master document, identifying the responsible person or group prepare remediation plans document decisions, actions and resolutions determine level of confidentiality required identify internal groups that need to have special communications developed (e.g., sales force) develop effective internal communications strategy for the organization identify all external stakeholders and audiences and develop a communications plan oversee the corrective actions

External Management of a Crisis - Informing the regulatory authorities as soon as possible regarding a new issue, or working with the authorities as soon as an issue is identified externally, is critical. - The world of negotiation is built on data, compliance actions and resolution in a timely fashion. - The CMT must demonstrate credibility, commitment and trust in the regulatory discussions. - Most of the communication in the early stage of crisis management probably will be verbal, so those communication skills need to be excellent. - Management of a crisis most often requires communication with other stakeholders. - New programs may need to be developed to address patient risk; this could be the establishment of a registry or development of informational or educational tools. - Other stakeholders could be vendors, partners, shareholders, the financial community, the legal community, the media and the public.

Continued - Additional activities for management of the external stakeholders include: identifying all external stakeholders or other relevant audiences developing communications strategies and planning with internal experts including appropriate external experts, if needed training internal staff to respond to inquiries (e.g., sales force) preparing briefing documents, if necessary revising labeling, developing educational tools developing Q&As for external inquiries

Post Resolution Assessment - All information obtained should be used to improve knowledge and current and future practices. Analyses of systems, procedures and operations should be conducted, with recommendations for required changes. Documentation should be developed and training should be conducted, through preparation or modification of standard operating procedures (SOPs) or guidances. Lessons Learned should be shared within the organization and imbedded into the institutional memory.

Averting a Crisis - While not every crisis can be averted, it would be extremely beneficial for the organization to develop an ongoing process to obtain information and analyze operations within the company in an effort to minimize any crises derived from in-company issues. - Most companies do this through SOPs, training and audits. - It is critical to share communication of the risks and the risk environment with management. - Understanding the impact is important for lessening the risk before it occurs.

Continued - With the above knowledge, it would be valuable to develop a crisis management guide that would lay out general steps to be addressed in most crises. Major categories could be: process for establishing a CMT team member roles team responsibilities identifying the issue and cause key stakeholders developing a task list timeline requirements Good Documentation Practices correction action plan internal and external communication plan

Skill Sets Required - It is imperative that the regulatory professional have some specific skill sets to be successful. Of course analytical skills are needed, but as important are the negotiation and conflict-handing skills with both co-workers and Health Authority personnel. Developing trust and respect is built on integrity, personal commitment and initiative. Teamwork and excellent communication skills provide opportunities for success. Adaptability and flexibility are needed to manage the situation as the risk unfolds.