FDA EXPERIENCE WANTED

If you work in pharma, biotech, medical devices, or any other industry regulated by the FDA, I feel safe in saying you probably have had, at some point, what I call FDA angst. You know what that is. It’s that feeling you get when you are trying to prepare for an inspection, or worse the FDA just shows up at your door. Maybe it is the headache and anxiety you get when the Warning Letter or Import Alert arrives. Whatever the situation, you turn to your experts.

Your experts may be in-house, highly qualified, and talented individuals who have great experience in FDA matters, or maybe you reach out to your consulting partner to provide you with the expertise you may not have within. Either way, you are highly reliant on the expertise and guidance of your business partner. And, sometimes, unfortunately, when you need that expertise the most, it falls short. The question is why it falls short and how you could have avoided what undoubtedly made an anxious situation even more difficult.

In my experience, the answer is not being able to discern one expert from another. The type of experience an individual brings regarding FDA is vastly different amongst individuals who worked for FDA and those who worked with FDA. Being able to distinguish between these skill sets is the key to hiring the right person for your organization and to hiring the right consulting partner.

So…What Did You Do?

FDA is a complicated organization when it comes to titles. For example, Consumer Safety Officer, Investigator, Inspector, Reviewer, Program Manager, and the list goes on and on. The key to success here is understanding what the actual role and duties were of the individual holding the title and what they were not. The situation is no different when considering an individual with industry experience for a position. If a member of industry says they have FDA experience, what does that mean?

Investigations and Compliance

Consumer Safety Officer is an umbrella term that has many different functional titles below it. For example, all Investigators are Consumer Safety Officers, not all Consumer Safety Officers are Investigators. Investigators conduct complex inspections and investigations. Inspector is a term once used for a less senior level of worker who performed mostly import examinations and sampling at the border ports of entry.

To further the confusion, the general sense of understanding of these positions may be far removed from reality. Investigators, most often called Inspectors by industry partners, are disregarded by some, feared by others and their “power” is misunderstood by most. To keep it in basic terms, Investigators conduct an inspection, make observations, which are their professional opinion on your compliance with the regulations and law, write a report, and make an initial recommendation to their supervisor on the classification or outcome of the inspection. They do not make final decisions on inspection outcomes, they do not write “violations”, they do not, with few exceptions, comment on your written responses, and they do not, with few exceptions, participate in any compliance actions. Those exceptions apply to Investigators who are Specialists and/or National Experts who may be called upon to review responses and provide opinions.

If you have ever been inspected, you’ve likely heard an Investigator say, “I can’t consult for you. I can’t tell you how to fix it” or even suggest mechanisms. That is factual. The job of the Investigator is to evaluate and identify potential problems but not to solve them or recommend solutions to industry. This is a key understanding of the skill set of the role. In industry terms, Investigators are auditors.

Specialists and National Experts are Investigators with advanced knowledge, training, and skills in specific commodity areas. Their expertise means they have a bigger role in partnering with compliance in establishing cases for enforcement and reviewing industry responses. National Experts report to the Center in their area of specialty and focus heavily on international inspections. They have more autonomy when it comes to providing guidance, yet they remain forbidden from playing the role of consultant.

Investigators report to Supervisory Consumer Safety Officers (SCSO). The SCSO role is to manage the work of their team and to review the Investigator’s report and recommended inspection classification and agree or disagree with that recommendation. The Director of Investigations, also an SCSO, is responsible for the entire investigative team and support system within their area of responsibility, such as Device Division 1. The Director of Investigations (DIB) has a key role in recommending any compliance actions to the Director of Compliance (DCB), also an SCSO. Further, the DIB is a partner to the DCB in matters of reviewing industry responses to inspectional findings and in participating in regulatory meetings with industry.

Compliance Officers at the Division level are also CSOs/Investigators, just to make things more confusing. The role of the compliance officer is to review the recommendations from the DIB and prepare actions for review by the DCB and others. The compliance officer must determine if the recommendation is supported by evidence and must associate the regulations with the Observations. Compliance Officers frequently correspond with industry regarding their inspection outcomes and their responses. The Compliance Officer will work with the DCB and DIB, where appropriate, to determine if the immediate inspectional response is adequate or if recommended actions should be sought. They have a larger role in determining if industry’s corrective actions are sufficient.

Above the Division level in ORA, there is an Office of Enforcement. Within that office, individuals review compliance cases referred from the Divisions and determine support for actions. Additionally, Centers, such as the Center for Drug Evaluation and Research (CDER) maintain the Office of Compliance where compliance officers make decisions on compliance actions and inspectional outcomes at the Center level.

Regulatory Submissions

A Reviewer is an individual who works in one of the Center’s and conducts regulatory review of submissions such as NDA, ANDA, BLA, PMA, 510(k), etc. There is no requirement, and most frequently it is not the case, that a Reviewer has any experience that an Investigator has, and the same goes for the Investigator. Most Investigators have no experience in regulatory submissions. There is a clear distinction between the enforcement arm of FDA within Office of Regulatory Affairs, and the Centers’ review of marketing submissions and approvals. Again, there are exceptions. There have been instances where individuals have moved from one position to another but that is generally an exception to the norm.

Reviewers are routinely individuals with professional degrees or advanced scientific degrees. These individuals are experts in science. They work with other subject matter experts, including physicians, to ensure the science presented in the filing has been substantiated. It is not unusual for a Reviewer to accompany an Investigator on a pre-approval inspection (PAI) particularly of a new molecular entity. What you may experience is that the Reviewer has no questions regarding your quality system and is completely focused on the data within the submission. You can understand now why that is, the roles are completely different.

Industry Experience

When seeking individuals who can help resolve FDA inspection and compliance matters as a permanent part of your team, be sure to understand what they mean when they say they have experience with the FDA. As with the FDA, complex industry maintains many different titles and levels of responsibility. The title alone cannot answer the experience question and it should never be assumed that the title at one company is equivalent to the same at another.

Common roles within industry that may have “worked with FDA” include, auditors, entry level quality personnel, management representatives, senior quality personnel, regulatory staff, legal counsel, and operations, to name a few. What the individual did in that role is of significance.

Seasoned auditors within the organization are great at helping identify new or ongoing quality issues. This is key to preventing adverse outcomes with FDA and it is key to responding to an FDA action. If you have ever read a Warning Letter the ending is, “…this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.” It will be expected that you not only correct the observations and violations noted in the Warning Letter but evaluate and identify any other quality system gaps. A great auditor who understands your technology is a huge asset. Performing auditing services for an organization may be because of an FDA inspection or to prepare for an FDA inspection but does that qualify as experience working with FDA?

I’ve experienced resumes where individuals purport to have worked closely with FDA, only to find out that they were a junior quality member who was either assigned as a scribe in the inspection or as a document runner. Both roles are critical in an inspection, but I found “worked closely with” a colorful characterization.

Senior quality leaders and Management Representatives are frequently tasked with hosting an FDA inspection. Operations staff and leadership are routinely required to tour the Investigators and to describe the production processes. These skill sets are critical to successful inspection management and in my experience have made all the difference in how the Investigator reacts to the information received during the inspection. Again, while valuable skills, I would not characterize this as having worked closely with the FDA.

Title Does Not an Expert Make

Titles do not clearly define the roles and responsibilities, let alone the appropriate level of experience that you may be seeking. I began noticing as far back as 2005, that more and more ORA Investigators were entering the FDA, conducting inspections for a few years, and then moving to industry, selling themselves as FDA experts. And too often, I witnessed industry hiring these individuals finding out the hard way that the “experience” did not match the advertising.

There are numerous reasons why individuals enter the FDA and leave after only a few years of occupying any role. That is a subject for a whole different discussion. However, time in grade alone is not the only consideration. Understanding Investigator training and the varying FDA government grade structure is a good way to understand what the time working in the FDA reflects.

Investigators working in ORA are hired in General Schedule (GS) positions, grades 5, 7, 9, 11, 12 and now even 13. It used to be that Investigators began as a 5 or 7 and spent six months on the job before ever attending the three-week basic law and evidence training that begins their CSO training journey. Only after that training is successfully completed and having spent a year in grade, do they qualify for subject specific training. Subject specific training may take years to complete the entire complement while the Investigator is continuing to learn on the job. Prior to ORA Program Alignment (PAG) in 2016, all Investigators began their training in the foods program.

Several things have changed over the years. Program Alignment meant that Investigators were trained to work within one program area. If they had pre-dated PAG, they may have been fortunate enough to have been trained in commodities other than the one they were assigned to work in under PAG. Investigators entering after PAG were assigned to the program area associated with the district they were hired into. This has limited the skill set of the Investigator to one commodity.

Of further consideration is the Generic Drug User Fee Amendment (GDUFA). Under GDUFA the demand for Investigators markedly increased for FDA to meet the GDUFA deadlines. The FDA was already understaffed in this role, and to attract personnel given the low rate of pay, they created GDUFA Investigator positions. This allowed FDA to hire Investigators with specific educational or industry backgrounds immediately into the role as a GS-13 specialist level. While this gave them an immediate pay incentive, this did not magically teach them how to be an Investigator. In this instance, equating an individual’s GS rating with their experience is misleading.

The government works on a time in grade structure. Most of the time, it is 1 year between grades, up to the GS-12 level, although that is supposed to be based on performance. This means if an Investigator began as a GS-5 and exited the FDA as a GS-9, it is very likely they only had two years of experience. Further, if they entered as a GS-5 and exited as a GS-9 and reported they had been an Investigator for 7 years there may be some questions around performance.

Lastly, associating the roles and responsibilities to the GS level is of some value to understand. The GS scale ends at a GS-15. For example, the Director of the Office of Enforcement is a GS-15. To qualify to be a Compliance Officer, you must be a GS-13, and to be a Director of Compliance or Investigations, you must qualify for GS-14. Specialists must compete, that is apply for a GS-13 position and National Experts must compete for a GS-13/14 position.

As previously presented, industry titles, roles and responsibilities can be equally confusing when determining the ability to help an organization identify, prevent and/or correct quality system deficiencies and/or successfully navigate a submission. Perhaps some of the most valuable experiences an industry member can bring to an organization comes from some of the most extreme circumstances such as, significant Warning Letters, Import Alerts and Consent Decrees related to quality and Refusal to File and Complete Response Letters related to regulatory filings.

Industry members who are fortunate enough to contribute to remediation of FDA actions gain valuable experience. Each situation noted above requires significant time, resources, and management to overcome. Through the course of the remediation, communication with FDA is ongoing. Participating in FDA meetings, responding to ongoing correspondence and professionally articulating progress against corrective actions are skills that are not learned by reading or training. Those skills are valuable to the organization going forward, and valuable to the individual who may be seeking more responsibility in new positions. While some may choose to see an individual’s involvement in these types of remediation activities as a mark on their record, I would argue that the experience can be some of the most valuable in the industry.

Consultants

Overstating the obvious, consultants are no different than any other profession, not all individuals are created equal. Frequently consulting firms hire ex-FDA employees because that is what the client says they want, someone with FDA experience. And frequently consulting firms themselves do not know what they are getting or what questions to ask when hiring ex-FDA employees as independent contractors or employees. Further, consulting is a very different business than industry or FDA.

Ex-FDA Investigators may struggle with the adjustment of not having authority to back up their opinions. In the consulting world, your client is your business partner, and the consultant has no authority, only influence. And, as we’ve learned, just because someone worked for the FDA does not mean they can solve problems but may be experts at finding them. It is equally as important when hiring a consulting partner to understand the background of the staff supporting your project. If you need an audit, and ex-Investigator may be just the person for you. If you are seeking serious support for remediation or preparing a response, you want a more senior FDA role.

Seeking the Unicorn

In an ideal world, unicorns would be plentiful. Unicorns are those individuals who have senior FDA experience, industry experience and have been in the consultant world as well. They are called unicorns for a reason.

While unicorns may be rare, there are many very good, highly skilled individuals ready to contribute to your success, rather they are from industry, ex-FDA, or consultants. The key to selecting the right person for the right job is simply understanding the environment they grew up in and knowing what questions to ask. And, if you find a unicorn, hang on to it, remember they are rare.

If you find you need a consulting partner for training, inspection readiness, independent quality system or supplier assessment or the most complex remediation strategies, please reach out. I would be happy to support you or even help you find the right consulting partner if I am not the best fit for your project.

www.rchaseconsulting.com rchaseconsulting@outlook.com