by Mark Schwartz Of Counsel, Hyman, Phelps & McNamara P.C.
There have been at least four FDA initiatives, in the works for some time that, in the coming years, will change the way pharmaceutical (and indeed all FDA) inspections are conducted. We think you should know about these initiatives, and how they are likely to affect the way companies prepare for, and deal with, FDA inspections. Today, we are going to discuss the Program Alignment Group (PAG) plan, arguably the least controversial of the four. Over the next few weeks we will discuss the other three programs that are likely to dramatically affect the inspection landscape.
Way back in September of 2013, then Commissioner Hamburg tasked some senior FDA officials with “…developing plans to modify agency functions and processes to best achieve mission-critical agency objectives.” The advice that the officials subsequently provided to Dr. Hamburg recommended that FDA’s regulatory and compliance activities be organized around “commodity” based and vertically integrated regulatory programs. See Program Alignment Group Recommendations – Decision Memorandum (Feb. 3, 2014). The six commodity based programs are: pharmaceuticals, biological products, medical devices and radiological health, food and feed products, tobacco and bioresearch monitoring.
In other words, the marching orders from the Commissioner were to develop a dedicated corps of specialized ORA investigators to conduct inspections exclusively within a particular area of expertise. The thinking was that product areas are becoming much more complicated and highly specialized, both because of ever increasing regulatory requirements and because improved technology is playing an increasing role in product development and in manufacturing. Hence, shouldn’t the inspection force be equally as specialized?
In other words, if you are spending two-thirds of your time as an investigator inspecting run-of-the-mill food, feed or tobacco facilities, does it really make sense for that same person to also be conducting inspections of recombinant biotech drug firms? The answer seems self-evident, until you realize that little in a huge bureaucracy is self-evident, and even less is readily achievable even when it is self-evident.
Dr. Hamburg’s objectives went beyond specializing, or commoditizing, the inspectorate, and also included commoditization of the laboratories and the compliance officers who manage the results of the investigations. According to the then Commissioner: “[t]he goal should be to have a cadre of compliance officers across the Agency who have a similar level of technical expertise as the specialized investigators and who can work more closely with Center experts on complex scientific, manufacturing, and other regulatory challenges.” Id.
The PAG plan includes developing the commodity programs out of the Office of Regulatory Affairs’ (ORA’s) 20 district offices. Each district office will focus on only one category of product, based on geographic location.
So, what to make of these objectives? From an industry perspective, having specialists, rather than generalists, analyzing a firm’s key systems seems like a no-brainer in terms of the specialist being better able to understand the complexities of the businesses being inspected and developing a better understanding of the inspected firm’s concerns. However, that alone does not mean that the quality of future inspections will be satisfactory.
Team Biologics, a specialized group of ORA investigators who inspect most CBER-regulated facilities, is perhaps the model for the PAG plan. While employed at FDA, this author observed that Team Biologics’ inspections have clearly raised the bar on the FDA inspectorate as a whole. However, the quality of such inspections, and inspectional observations, still varies widely, both between lead investigators and between facilities inspected, almost twenty years after the inception of Team Biologics. In other words, this development is a necessary, but not a sufficient, condition to thorough and fair inspections.
One thing is certain. Firms that have thus far counted on investigators not discovering fundamental problems with their key systems are less likely to succeed after the PAG plan’s implementation, owing to the greater level of knowledge and specialization of investigators.
The PAG plan also seeks to reduce layers of review, and encourage closer collaboration between Center staff and field inspectors, with the goal of eliminating duplicate work and speeding up inspectional findings to manufacturers. Indeed, FDA officials have stated that the changes are expected to accelerate re-reviews of facilities looking to regain compliance status and “not leave firms in OAI status for a long time…” (Apparently, another objective is to halt violative imports more quickly by de-linking import alerts from warning letters). See, e.g., Statements by Tom Cosgrove, Director of the Office of Manufacturing Quality, CDER, at last year’s PDA/FDA conference While most of these are laudable, and indeed desirable, goals, it is wholly unclear whether the PAG plan can achieve these objectives.
Without a doubt, this portion of the PAG plan seems the least realistic, as it anticipates the removal of layers of bureaucracy without the hammer of a statutory mandate or new funding specifically earmarked by Congress (broadly, like what exists with the user fee programs). Finally, it does not appear to consider the possibility that accelerating the delivery of inspectional findings in a huge bureaucracy will diminish the quality of the work product.
The agency’s goal is have the new model in place for fiscal year 2017. FDA, and its sundry components, has undergone various reorganizations over the years, often without achieving many of their key objectives. This is one that many people unambiguously hope is properly implemented and successful. However, it has the added complexity of needing to be implemented by a new Commissioner, who is in the final year of the second term of a presidential administration.
As always, we will keep you posted on developments.
Reprinted with permission from FDA Law Blog
Mark L. Schwartz, Of Counsel at Hyman, Phelps & McNamara P.C., advises clients on biologic, drug, and device compliance, as well as on regulatory issues. He joined the firm after spending close to 13 years at the Food and Drug Administration in various capacities. Most recently, Mr. Schwartz was CBER’s Deputy Director in the Office of Compliance and Biologics Quality, an office with approximately 140 staff members. As Deputy Director, he advised the Commissioner, the Center Director, the Director of the Office of Compliance and Biologics Quality, as well as various offices within CBER and CDER on a variety of compliance issues involving biologics, drugs and medical devices.
Mr. Schwartz has published extensively on FDA-related issues, including op-eds in The New York Times, Barron’s, The International Herald Tribune and The Financial Post, among others, and he has been an Adjunct Professor of Food and Drug Law at both George Mason University School of Law and Howard University School of Law. Before joining FDA, Mr. Schwartz was a commercial litigator in Washington, D.C., and prior to that, in his native Montreal, Canada. He is a graduate of Duke University School of Law and l’Ecole de Droit de l'Université de Sherbrooke (Canada), as well as McGill University (Canada).