The recent and highly publicized Supreme Court decision in Wyeth v Levine brings into sharp focus an aggressive expansion of risk for pharmaceutical companies. Specifically, the ruling sets a precedent that approval of drug labels by the FDA does not protect against lawsuits in individual states.
While FDA compliance has never been defined as comprehensive shelter from litigation, it has been adopted as a fair measure of protection. This turn of events, however, exposes that false sense of security and presents a new level of legal vulnerability in the realm of drug safety warnings.
In the coming years, there will be significant adaptation on both sides of the law. States will have to revisit their safety guidelines and possibly overhaul their review structure; in the meantime pharmaceutical companies face the daunting task of recalibrating risk in a rapidly evolving environment.
Never has it been clearer that global product needs a global view of compliance issues. Such a mindset was already evident in some aspects, given the highly complex process of managing information and marketing to a multi-border network. Global manufacturing and distribution calls for a continuously updated understanding of how product interfaces with numerous regulatory requirements. The process requires diligent assessment of the risk and reward of making a change, internal coordination to ensure the change touches every affected party, and external coordination of local organizations that must gain regulatory approvals at the right time and update the relevant documentation.
Pharma companies will need to make quick adjustments to guard against the potential rush of state level litigation. While further developments are sure to follow, today the mindset must be focused on assessing risk, placing the risk within the organization, and owning the risk â€“ with no illusions that such a burden can be shared with corporate partners or government agencies.
Assess and manage the risk
Certain products clearly have more risk associated with them than others, for instance through the severity of potential side effects. A review of the warningsÂ associated with these products is now a priority.
Additionally, each product has tiers of risk that should be assessed from a regulatory perspective. In the event of an investigation, every label change in every region will be exposed to scrutiny and therefore must be fully rationalized. Companies will need to demonstrate a documentation trail that provides a complete and global perspective; a national view of the world will invite questions about regional differences and the level of warnings included in the label.
Companies should generate a repository that tracks the history of a label, with the change process record, the content and the changes themselves as part of this corporate memory.
Place the risk
From a process perspective, organizations must decide where the risk and process management will fall. Because the scope of change is so wide â€“ affecting not just regions, but business units as well â€“ companies should be certain that each change is governed by a sponsor who is held accountable for ensuring that the proper next steps are triggered and seen to their conclusion. For example, should a manufacturing plant employ a new production method to cut costs, the sponsor of that change will move the process to a consideration of labeling as well. This ensures that the different silos found within many organizations do not impact the quality of regulatory compliance.
Whether the sponsorship and documentation process is driven centrally or distributed across the organization, it will be crucial to consider all the regions and functions in which the change might be relevant. Decisions could impact such wide ranging elements as geography, type of product, and marketing strategy (ie, some products are prescription in one geography but over-the-counter in another). Properly enacting and tracking changes will be the key to minimizing exposure.
Own the risk
Above all, pharma companies must never lose sight of the fact that the risk rests wholly on their operations. Third party outsourcing of everything from R&D to regulatory interaction is accepted as common practice, but the exposure to litigation will always remain with the controlling entity: process can be delegated, but accountability stays at home.
Molding risk management around this sense of full ownership offers a high degree of confidence in operations, if not full protection from litigation. It also presents an opportunity to filter improved procedure throughout the organization; artwork and labeling may be a different element from Chemistry, Manufacturing & Controls (CMC), but the two will certainly interact as sponsors lead their changes through the various triggers. By solidifying policy and procedure and allowing for flexibility in the details, pharma companies can improve their risk profile from multiple angles.
Wyeth v. Levine opens a host of issues that will require a response from all parties. State label laws will have to be reassessed to align standards with a risks and benefits equation that affords protection from side effects but still allows patients to enjoy the positive effects of a drug. The FDA, meanwhile, will have to prepare for a massive influx of requests to review and approve new labels.
Unfortunately, pharma companies are in no position to sit idle and wait for new parameters to be revealed. Indeed, the industry as a whole has serious adjustments to make, with risk assessment, placement and ownership at the core of the new labeling paradigm.
Craig Wylie is a member of PA Consulting Group’s management team, in the firm’s Life Sciences & Healthcare practice. Â He specializes in the issues surrounding regulatory and internal compliance for pharmaceutical companies