What Influences the Compliance Culture at FDA?

March 4, 2020

The Office of Compliance (OC) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) is a large organization.  It has hundreds of personnel who are assigned to five component offices and multiple sub-offices with a mission to protect patients from poor quality, unsafe and ineffective drugs.

The five component offices are: (1) Office of Drug Security, Integrity and Response (ODSIR); (2) Office of Manufacturing Quality (OMQ); (3) Office of Scientific Investigations (OSI); (4) Office of Unapproved Drugs and Labeling Compliance (OUDLC); and (5) Office of Program and Regulatory Operations (OPRO).  For more detailed information about the functions of each of these offices, see the Annual Report from the Office of Compliance for 2018 here.

In the Annual Report, both risk-based policies and decisions (emphasis added) are part of the “Director’s Message” and the “Mission” sections.  These are indicators that controlling harms is a feature of the compliance culture that the agency is creating.  But if you’re not working inside the agency within the Office of Compliance, what information can you find in the public domain that can help you better understand the regulator’s risk-based culture and better anticipate how FDA might react in certain situations?

Fortunately, there are some sources that we can turn to that give us some of that added insight. I’ll discuss three in this blog – two books and a short video on YouTube® by Malcolm K. Sparrow - focused on controlling risks and harms, solving problems, and managing compliance.  Mr. Sparrow is a Professor of the Practice of Public Management at Harvard University Kennedy School of Government and Faculty Chair of the school’s executive program “Strategic Management of Regulatory and Enforcement Agencies.”

More information about Professor Sparrow can be found on his faculty directory page here. I’ll identify each of the books, list some of the key points and themes that Professor Sparrow raises in each book, provide a link to the YouTube® video and then demonstrate how one specific sub-office in the Office of Compliance is applying some of these points.

Let’s begin with the first book, The Regulatory Craft (The Brookings Institution, 2000). In the book, Professor Sparrow contends that the central purpose of regulation is the abatement or control of risks to society.  He discusses various public agencies that have confronted the risk-control challenge directly, developing operational capacities for specifying risk-concentrations, problem areas, or patterns of noncompliance, and then designing interventions tailored to each problem.

These are some of the points that Professor Sparrow raises in the book that describe the culture of regulatory agencies that are effective in controlling risks:

  • Regulatory and enforcement operations are most effective when constructed around an explicit risk control strategy.
     
  • By choosing wisely a regulatory agency can take an unmanageable accumulation of laws, many of which might be obsolete, and deliver perfectly reasonable regulatory protection.
     
  • Close engagements with other parties, some good and some bad, can produce more effective, resource efficient solutions.
     
  • There are three important competencies for a regulatory agency to have the capacity to risk control: (1) functional expertise; (2) process management; and (3) problem solving strategies.
     
  • Regulatory agencies need to create techniques and systems for making invisible or underrepresented problems visible and for spotting emerging problems early before much harm is done.

  • A balanced compliance strategy results in an allocation of resources that retains a credible deterrent while garnering public relations benefits and resource efficiencies of more cooperative methods.

  • Risk management provides a structured way of being flexible and should be an integrated program of activities that is institutionalized into the way that the agency conducts its business.

  • Agencies that are faced with a violation and decide not to initiate enforcement action have a broader range of alternatives from which to choose.

  • The better an agency understands a risk and more insightfully analyzes it, the less brute force will be needed to suppress or contain it.

 ​The second book is The Character of Harms – Operational Challenges in Control (Cambridge University Press, 2008). The fundamental claim of the book is that there are distinctive patterns of thought and action that accompany the reduction of harms.  Rather than trying to develop regulatory strategies to promote public safety, Professor Sparrow suggests that successful regulatory programs demonstrate a pattern of thinking that involves detailed scrutiny of the harms that then leads to effective interventions to sabotage those harms.

These are some of the core points that Professor Sparrow raises in this book:

  • It makes sense to regard patterns of non-compliance as analogous to real harms.

  • There are four important properties of innovative approaches to harm reduction: (1) addressing specific, tightly defined classes of harms rather than more general classes; (2) a prolonged period of analysis and inspection; (3) the interventions used were new and not a mix of existing methods; and (4) the regulatory organizations worked in collaboration.

  • Harm reduction agencies need a much higher level of analytical versatility than functional or process-based structures.

  • Long term harm reduction success means is spotting emerging problems early and suppressing them before they do much damage.

  • There is a successful seven-step problem solving protocol for harm-reduction agencies: (1) select potential problem for attention; (2) define the problem; (3) determine how two measure impact; (4) develop solutions or interventions; (5) implement the plan; (6) periodic monitoring; (7) project closure.

  • The control of serious harms in hostile environments where compliance is peripheral to the enterprise requires harsher methods and less generous presumptions.

  • Conscious opponents – those who deliberately evade the regulatory scheme – will deliberately select new tactics and methods that defeat existing surveillance and reporting systems.  When regulators are nimble and adaptable then the conscious opponents can’t settle into a comfortable routine and their operations can be disrupted or dismantled.

  • When regulatory agencies face conscious opponents, revealing too much about strategy and tactics might render the controls ineffectual.  This needs to be balanced with policies and requirements of agencies that affect transparency, predictability and communicating priorities.

  • Prevention is of paramount importance for catastrophic harms because of the extreme seriousness of the potential consequences.

  • Where the probability of a catastrophic harm, though small, is not negligible and where the consequences of an event could be enormous, the challenge is to stimulate public and political attention to the risk and maintain it at a reasonable level and for very long periods of time.

  • For catastrophic events where there are not enough incidents to analyze effectively or to provide meaningful statistical evidence of any reduction in risk, it helps to select precursor conditions that occur with greater frequency as a way of gauging progress.

  • In situations where an industrial sector is largely out of compliance with regulatory requirements, the widespread non-compliance tends to sustain itself producing forces that counteract any gradual shifts towards compliance.  Efforts to change the situation either need to be substantial and concentrated, sufficient to alter the prevailing condition, or their effects will dissipate over time.

As a supplement to these books, here is a brief video of Professor Sparrow discussing harm prevention.

Now let’s have a look at how the activities of one sub-office within the Office of Compliance stack up against some of the points described by Professor Sparrow.  The Office of Manufacturing Quality (OMQ) evaluates compliance with manufacturing requirements for drugs based on inspection reports and evidence gathered by FDA investigators. 

OMQ develops and implements compliance policy and takes risk-based actions to protect the public from adulterated drugs in the U.S. market.  Check out this link for more details

Here’s a chart to illustrate how OMQ’s culture and operations compare with the cultural characteristics discussed by Professor Sparrow.

Table illustrating how the Office of Manufacturing Quality's culture and operations compare with the cultural characteristics discussed by Professor Sparrow.

Taking the time to learn how to understand a federal enforcement agency’s culture can pay dividends to your organization  when facing the rigors of inspections and reviews of regulatory applications.   Moreover, this is a prudent measure for designing more effective compliance systems and reliable business operations that are more likely to meet regulatory requirements and instill trust in regulators.

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