Pharmacovigilance: Challenges in Getting From Here to There

Regulatory Gap. As the oldest of the comprehensive national/regional regulatory systems, the US Food and Drug Administration uses concepts and tools that came together over decades in an ad hoc way to deal with the exigencies posed by tragedies and disasters over the 20th century up until the quinquennial statutory reauthorizations of the user fee act, beginning in 1992 with the Prescription Drug User Fee Act. In addition to creating a sustainable payment mechanism to provide for the timely review of applications, it is important to recognize that this statutory mechanism also initiated a prospective, stakeholder–collaborative, interventionist approach to addressing simmering issues that has largely succeeded in heading off new tragedies and disasters. Examples include the development and access of new drugs for pediatrics through renewed, then permanent, legislation (Pediatric Research Equity Act and Best Pharmaceuticals for Children Act) and the multifaceted, expedited regulatory tracks for serious conditions. The user fee mechanism has further been applied to biologics, medical devices, generic drugs, and veterinary products, primarily to secure adequate regulatory talent to provide timely review of product applications. However, several additional areas remain in need of attention: the regulatory gap between release of a manufactured product and reporting of an adverse event following patient exposure, the long-neglected regulation of food additives, the troublingly inadequate regulation of nutritional supplements,^,  and the near absent regulation of personal care products. There is also the issue of harmonization. In the 1980s and 1990s, there were tremendous advancements through cross-cutting global collaborations under the Council for International Organizations of Medical Sciences (CIOMS) and the International Conference (later to be changed to Council) on Harmonisation. However, the last decade has seen these efforts stall, with much at risk of loss: continued improvements in the efficient use of resources; greater speed and continued standardization of processes; and high public confidence in the collaborative, multilateral leadership that gained these achievements.

PV Talent Gap: The dramatic growth in PV regulatory drivers over the past 2 decades has had the unintended consequence of creating a pressing shortage of well-trained, professional talent, both medical and operational. It is not a problem for any one company to solve; it is a collective problem that is in a stand-off. Any individual company's effort to train a cadre of professionals from scratch invariably leads to recruitment overtures from other companies in need of similar talent, to the detriment of the first company. The European Union has found success in addressing this issue by creating the European Programme in Pharmacovigilance and Pharmacoepidemiology (EU2P) in 2009, a consortium of regulatory agencies, industry companies, and universities to provide training that leads to certificates as well as master and doctoral degrees. It is reasonable to anticipate that there will also be an eventual need for documentation of competency.

Seek executive level support for an extended commitment. Stakeholders can explicitly engage their respective senior managements to plan for and commit the necessary long-term resources (primarily talent, time, and money in varying proportions) concerning the issues covered in both of these themes.

Expand stakeholder involvement. There are additional stakeholders who would welcome engagement, including other academic and professional organizations (eg, the National Academy of Medicine, CIOMS, the International Society of Pharmacoepidemiology, the International Society of Pharmacovigilance), patient-based organizations (eg, the Patient-Centered Outcomes Research Institute), other industries with experience in managing risk (eg, airlines, financial institutions), information technology, and congressional interests.

Develop a road map for creating a collaborative vision. Use existing cross-cutting organizations (eg, CIOMS, International Council on Harmonisation) or develop other mechanisms to convene informal meetings to re-imagine the overall process through presentation of white papers, deliberation of topics, creation of agendas, and publication of findings and proposals.

Build the necessary infrastructure. With the EU2P model in mind, all stakeholders can collaborate to build the academic infrastructure for ongoing continuing professional education that can be shared among all interested parties to develop and expand the skill sets of present PV professionals and to provide a pipeline for newly trained talent. Success of this model with PV could be usefully applied to other areas.

Start the conversation. Submit a commentary to expand and/or critique the ideas presented in this Special Section with the goal of building momentum.