Thanks for the Warning Letter: Part I When it Takes a Warning Letter to Spur Company Action

[Editor's Note: Part II appeared in the February 2019 issue.]

In the not-too-distant past, I was driving to downtown Washington, D.C. on a rainy morning in September. After fighting the tortuous traffic, I finally arrived at the PDA/FDA Joint Regulatory Conference. My first order of business? Find that life-sustaining cup of coffee. After checking in, I made a beeline to the coffee stand.

After pouring the wonderous elixir, I turned around to see a gentleman patiently waiting to speak to me. He introduced himself as the quality head for a pharma company and asked me to step over to a quiet corner to talk. As we walked over to the corner, I quickly realized that I had just sent his company a warning letter a few months back. I expected him to simply give me the normal quick update on the remediation process. So, I took a swig and waited for his update. Then, the gentleman said five words that almost made me spit my coffee out.

“Thanks for the warning letter.”

After a hard swallow, I was able to get out a one-word reply, “Why?” After all, why would someone thank me for sending them a warning letter? Has this gentleman gone completely bonkers?

Some background, I am the former Director of the U.S. FDA’s pharmaceutical Office of Compliance. In this role, my colleagues and I were responsible for the CGMP oversight of all drugs manufactured in and/or imported into the United States. One of my many responsibilities involved approving, signing and sending warning letters to noncompliant companies. During my tenure, I unfortunately sent many warning letters. I say “unfortunately” because I received no pleasure in this activity as the issues I noted could often have been prevented.

In this two-part article, I aim to stir things up, ask some tough questions and create a healthy dialogue. The opinions and ideas are my own. They are ideas I have amassed throughout my career in the public and private sectors. I do not profess to have solutions to these complex problems. The solutions will not come from one individual. It is going to take all of us, which is why I wrote this article—to keep the dialogue going and, hopefully, catalyze more action. We cannot accept the status quo. It is not sustainable. Do you truly think the status quo in our industry is acceptable, and the patients we serve are getting what they need and deserve?

Let us begin with some background. What is an FDA warning letter? Chapter 4 in the Regulatory Procedures Manual (RPM), which is available on the FDA website, explains this. A warning letter is the “Agency’s principle means of notifying regulated industry of violations and achieving prompt voluntary correction.” While FDA uses this as a principle tool, the RPM goes on to note that a warning letter is “informal and advisory” and “communicates the Agency’s position.” It is not, however, a tool that is used hastily. FDA takes issuing a warning letter very seriously; a great deal of deliberation goes into the final decision to issue one. In turn, if a company receives a warning letter, they need to take it just as seriously.

A warning letter essentially tells a company that FDA has observed “violations of regulatory significance.” Significant violations are further detailed, as those violations “may lead to enforcement action if not promptly and adequately corrected.” When a company receives a warning letter, FDA expects the company to come into voluntary compliance within a reasonable time frame. If they do not perform the necessary corrections, FDA can, and will, move to more stringent actions, for example, an injunction, or, what I call, a court-ordered quality improvement plan. A warning letter is just one way FDA puts a company on notice that they have serious problems to fix. For this reason, FDA typically sends the warning letter to the most senior leader in a company (e.g., the CEO) to ensure that proper attention will be paid to preventing and fixing the noted violations.

Many different variables feed into the warning letter decision-making process. If you are interested to learn more, I encourage you to read through the RPM.

Back to that thankful gentleman at the PDA/FDA Joint Regulatory Conference. I asked him why he said thank you. He explained that he and his operations andmanufacturing colleagues had been trying to escalate their mounting problems to top leadership for quite a while, but the C-suite leaders did not take notice until the warning letter arrived on the CEO’s desk. Now that the CEO and his direct reports had been made aware, proper attention and resourcing was being directed to correct and mitigate the problems.

It is a sad-but-true scenario in our industry. I did not make up this story; in fact, other quality and operations leaders have said these same five words to me.

So, what can we as an industry do? How can we ensure our executives understand, know and appreciate the value of a robust pharmaceutical quality system? How do we ensure that, from the top of the organization to the line-level workers, our colleagues fully grasp the fact that quality is everyone’s job? How can we ensure a robust pharmaceutical quality system?

The answer: It depends. It depends on the pharmaceutical company and its organizational quality culture. What I mean is, each organization has to have an ingrained culture of how it does what it does. While the concepts and principles of quality are similar across the industry, the ways of implementing them within each company are nuanced based the culture of the individual company. Also, how to get and keep the CEO, Board and executive teams focused on quality is different for each company based on its particular culture. This is a complex conundrum that many great minds are trying to solve. For example, PDA has task forces on quality culture, quality metrics, postapproval changes, etc. Other organizations across our industry have other endeavors in progress, as well, to help improve our industry. As I noted above, no one individual has all the solutions.

The famous quality guru W. Edwards Deming once said: “94% of all failure (in an organization) is a result of the system…not people” and that “the basic cause of sickness in American industry… is failure of top management to manage.” I would expand upon this last quote and say the failure is not just with American industry, but with global industry, because Deming made these statements decades ago, before the advent of the globalized society that is our current reality.