Devine Guidance

You Have Just Been Disqualified, Ouch!

By Dr. Christopher Joseph Devine
April 2, 2014


• Categories: Devine Guidance

Folks, the doctor would like to begin by apologizing for not writing last week. Someone near and dear to me (Mr. Sal Monella) attempted to kill me through the fine art of food poisoning. It must have been pretty bad because all of the alcohol consumed by Dr. D at this barbecue was not able to prevent the onslaught of Sal’s revenge. Regardless, I am back and feeling much better.

This week the doctor is going to address a seldom if ever talked about subject, the disqualification of clinical investigators. Considering most Pre-Market Approval (PMA) devices are premised on the strength of the clinical study and the subsequent data, Dr. D believes that more attention needs to be paid toward the execution of clinical trials. Now after being ill for a few days, the doctor is still somewhat “knackered” (look-it-up) so this week’s guidance will be brief.

Disqualification of Clinical Investigators

There are two acronyms that are quite relevant to the overall protocol associated with the potential disqualification of a clinical investigator:

(a) Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE); and

(b) Notice of Opportunity for Hearing (NOOH). 

Dr. D would like to add a third acronym BAD, as in bad investigator. 

According to the agency, the NIDPOE letter is used to inform problematic clinicians the agency is commencing with an administrative proceeding to determine whether the clinician should be made to walk the proverbial plank or be disqualified from participating in clinical studies for violating FDA regulations. The NOOH is an opportunity for the offending clinician to have a hearing to discuss the pending qualification and provide evidence, on their behalf, as to why such proceedings are being pursued in error. 

Additionally, there are three categories associated with the disqualification process:

(a) Not Disqualified Clinical Investigator;

(b) Disqualified Clinical Investigator (a.k.a. Totally Restricted Clinical Investigator); and

(c) Restricted Clinical Investigator.

If the clinician provides an adequate response to the NIDPOE, then the agency can accept the response and halt formal proceedings. However, if the response does not pass the scrutiny of the agency an informal regulatory hearing is in the cards for the offending clinician. In short, “do not pass go and do not collect $200.00.” Once a clinician qualifies for the prestigious title of “Disqualified Clinical Investigator” the offending clinician is not permitted to receive investigational drugs, biologics, or devices. In fact, the offending clinician is restricted from conducting any clinical investigation, which supports an application for research or application to market products regulated by the agency. Can you say no IDEs or PMAs? 

For clinicians that FDA views as having less egregious violations of the law, the agency may agree to lesser sanctions that permits the offending clinician to continue to participate in clinical investigations; henceforth, Restricted Clinical Investigation. The all mighty and powerful FDA does retain the authority to enter into restrictive agreements with Restricted Clinical Investigators. 

Finally, unless there is a lifetime disbarment involved, once the terms of the restricted agreement have expired, the restrictions are removed. Simply stated, the sentence has been completed and the clinician returns into the good graces of the agency. However, make no mistake, FDA is watching. 

Why is this important? For starters, clinical trials are expensive. It would be absolutely foolish for device establishments to align themselves with a disqualified clinician. Depending on the size of the clinical investigation, millions of dollars could be quickly washed down the proverbial drain. In fact, it is just darn good business to pursue adequate due diligence and perform significant research on the individuals you are going to trust for execution a clinical investigation. It is not sufficient to collect the curriculum vitae of the clinicians. Device establishments must ascertain the status of the clinicians in the eyes of FDA. Dr. D strongly recommends a visit to the FDA’s disbarment page.

Takeaways

For this week’s guidance, the doctor will leave the readers with just one takeaway. Clinical trials are expensive, with the results a salient deliverable in support of the PMA process. If the clinicians performing the trials are categorized as Totally Restricted Investigators by FDA, then the clinical work is basically a wasted and futile event. Make sure an appropriate level of due diligence is pursued prior to partnering with the clinicians selected to execute the clinical investigation.

In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success.

References:

1. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon. 
2. FDA’s enforcement page. (2014, March). FDA.gov Website. Retrieved March 31, 2014, from http://www.fda.gov/ICECI/EnforcementActions/ucm321308.htm.