Dr. D would like to start this week’s guidance off by wishing all of the readers, living in the United States and celebrating Thanksgiving, a Happy Thanksgiving. I hope each of you enjoy the time spent with loved ones and can find something in which to be thankful. Thanksgiving has always been Dr. D’s favorite holiday. What is there not to like? Hopefully, there is plenty of food, football and booze (especially the booze). It is a fabulous holiday!

Ever since the doctor began writing Devine Guidance (DG) back in 2009, the salient focus has continued to be on: (a) medical devices; (b) quality, regulatory, and statutory requirements; and (c) device manufacturers, especially establishments that step into quality, regulatory and statutory excrement as they run afoul of the FDA. Most innovative devices, long before the commercialization process, require some level of clinical assessment. Can you say clinical trial? Device establishments work vigorously with clinicians and hospital institutional review boards (IRBs) to ensure robust protocols are scripted, physicians are adequately trained, and qualified patients are screened for inclusion into a clinical study. Now 99.9% of the time, this entire process works seamlessly. Unfortunately, bad things, driven by poor decisions made by clinicians, happen. When such violations of clear and inviolable (look-it-up) rules occur, the FDA steps in and takes appropriate action (a.k.a. severely punishes the offending clinicians). Can you say disqualification? Enjoy!

Clinician Disqualification Process

Similar to device establishments, the FDA is tasked with providing oversight for the actual execution of clinical studies. In fact, on occasion, the FDA has issued warning letters to clinicians and device establishments when perceived regulatory and statutory violations are noted during the execution of a study. During this process, there are few things that motivate the agency faster than a significant number of adverse events, especially when these event result in patient deaths. You see the FDA is entrusted with protecting the rights, safety and welfare of human subjects participating in a clinical trial. When allegations associated with clinicians violating regulatory and statutory requirements surface, the FDA can commence with the disqualification process.

The disqualification process starts with the issuance of a Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) letter. The letter is the initial step in the clinician disqualification process. The letter is the vehicle employed by the FDA to inform the clinician that administrative proceedings are moving forward to ascertain if the offending clinician should be barred from receiving investigational devices used in clinical trials. Since this is the United States, the clinician, under investigation by the agency, will have the opportunity to defend him or herself (due process). The Notice of Opportunity for Hearing (NOOH) is the tool that the offending clinician can use to request a hearing in front of an FDA officer selected by the commissioner. No bias here, folks.

There are three possible outcomes as a result of the hearing: (a) no further action pursued; (b) disqualified clinical investigator (formally totally restricted investigator); and (c) restricted clinical investigator. For clinicians that have:

• Repeat regulatory and statutory transgressions
• Willfully violated regulatory and statutory requirements, and/or
• Provided false information, relating to a clinical trial, to a sponsor

Disqualification is in the offending clinician’s future—no crystal ball is required. Once disqualified, the investigator is no longer eligible to receive investigational devices needed in support of clinical trials. This ban is essentially permanent, until the offending clinician has been reinstated by FDA. The FDA has a published list of disqualified clinicians that Dr. D strongly recommends all device establishments review, prior to selecting and contracting with a clinician.

A Restricted Clinical Investigator may, on occasion, be granted special dispensation from FDA to enter into a restricted agreement, when such agreement would benefit the need to protect the public health. Simply stated, FDA will permit clinicians in the restricted category to receive investigation devices, provided the offending investigator conducts regulated studies in accordance with the restrictions imposed by the agency. Once the FDA has determined that a restricted clinical investigator has learned to play in the agency’s sandbox in accordance with its rules, the restriction can be lifted.

Takeaways

For this week’s guidance, there are no takeaways. Dr. D just wanted to provide some insight into the consequences associated with bad clinical behavior. As mentioned in this week’s DG, warning letters, although not a common event, can be awarded to device establishments and clinicians when bad decisions are made, either unintentionally but frequently or intentionally, regardless of frequency. 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. Code of Federal Regulation. (April 2015). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
3. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
4. FDA. (2012). Clinical Investigators – Disqualification Proceedings. Accessed November 21, 2015. Retrieved: http://www.fda.gov/ICECI/EnforcementActions/ucm321308.htm.