Prescribed Behavior: Operating Under a Consent Decree - Pharmaceutical Executive


Prescribed Behavior: Operating Under a Consent Decree

Pharmaceutical Executive

Organization & People: Focus on culture and resource management

The origin of corporate culture is leadership. Under a CD, appointed leaders should demonstrate an ability to drive change throughout the organization. But rather than assigning top talent to base business operations, consider deploying leaders on the more complicated and critical portions of CD commitment. An individual's penchant for problem-solving should be prioritized over a history of compliance or quality assessment experience to succeed in a complex, high-pressure and regulatory-constrained environment.

Once the best talent has been placed, and metrics have been assigned to assess and confirm these roles over time, it's just as important to clearly define responsibilities, interactions and hand-offs with existing governing bodies across the organization. In addition to structural changes—committees and managers who oversee the CD remediation effort should report directly into the C-suite—companies should focus on the importance of knowledge transfer. The volume of external contractors and the constant ebb and flow of project team resources require robust mechanisms for sharing information, resources and insight. Without a combination of clearly defined responsibilities and efficient knowledge transfer, resources are lost in the revolving wheel of project teams and contractors.

CD commitments can dominate many areas of the organization and dramatically impact the culture. Leadership should proactively monitor cultural changes stemming from the execution of CD commitments, while simultaneously defining and shaping a future-state organizational culture of quality and compliance.

Communication: Under-commit and over-deliver

Dialoguing with regulatory officials and internal stakeholders about the requirements and outcome of an enforcement action can be a ticklish (and tendentious) affair, but there are good and bad ways to negotiate and then execute the terms of a settlement. Fines and other penalties related to delays can compound an already undesirable position, sending share prices down and damaging a company's credibility with the FDA. Minor delays will inevitably occur, but a well-considered strategy and communication plan can mitigate and sometimes prevent the more costly infractions associated with remediation.

One of the biggest mistakes that clients make is the submission of a plan with a compressed and aggressive timeline that is unlikely to be met. There is little to no advantage in giving regulatory authorities project timelines that are overly optimistic and that place an unnecessary strain on project teams. In their anxiety around the future and the haste to appear responsive to regulatory agencies, many senior executives task the development of commitment plans and timelines to the regulatory and quality team. While this may appear prudent on the surface, these individuals – though very knowledgeable and skilled in regulatory compliance and quality principles – may not have the operational knowledge or experience when it comes to execution. The right mix of regulatory, quality and operational experience is necessary to develop pragmatic timeframes that recognize the realities of day-to-day operations. We aren't suggesting that senior executives knowingly marginalize the importance of the CD, but many simply don't realize the magnitude of the impact to the base business and the critical need to manage both in an integrated fashion.

A communication plan for internal stakeholders is also important, since the execution of CD commitments is a long-term journey requiring the participation of all employees. Understanding the specific needs of different stakeholder audiences is key to delivering the appropriate messages—in the right place and at the right time—to keep employees informed and committed.

Risk & Sustainability: Quality and the core business

Companies sometimes overcompensate for compliance shortcomings at the beginning of a CD: a non-compliant, production-focused operation that over the years swung the pendulum further away from quality and compliance suddenly overnight swings in the direct opposite direction, focusing on quality and compliance while neglecting production. While this may be necessary to deal with short-term issues, over-restrictive procedures leaning heavily on oversight and reactive methodologies can be unsustainable over the long haul. Once these restrictive processes are in place, they can be very difficult to back away from.

To avoid a quality and compliance function that compromises core business objectives, sustainability should be built into revised standards, procedures and associated documentation. Using a post-facto "inspect quality" mindset across the board can hamper recovery; processes should reside in a system that is both compliant and viable from a business standpoint. Building sustainable processes and systems may take a little longer, but is well worth the wait over the longer term.

The importance of balancing risk and creating a sustainable model that can outlast the terms of a CD can make or break a company. Organizations that identify and then walk the middle line, which minimizes shortcomings on both the quality/compliance and business objective sides of the equation, position themselves for a successful outcome.


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