A couple of weeks ago, the doctor wrote about Chief Jailable Officers (CJO) doing bad things and being justly rewarded for their transgressions. Two weeks later the FDA (courtesy of the U.S. Attorney’s Office and the United States District Court for the District of Minnesota) has given Dr. D the opportunity to write about bad things happening to one of the device industry giants, Medtronic. A dear friend of Dr. D’s (yes, the doctor does have friends), Richard Anderson, brought this recently issued consent decree to the doctor’s attention. For those of you who are unfamiliar with the consent decree process, a decree is essentially the FDA’s ultimate legal recourse to force establishments that are failing to comply with regulatory and statutory requirements to finally comply with federal regulations or face the ultimate wrath of the federal government—heavy fines and potentially, some serious prison time for the CJOs (if there is clearly criminal intent). When the panjandrums (look-it-up) of the justice department get involved, at the request of the agency, bad things are surely about to happen, especially as the signatures are affixed to the bottom of the consent decree. Before the ink on the decree dries, the CFO is already preparing to commence with the writing of some pretty big checks. Why? Because the execution of consent decrees are unbelievably expensive. Ouch! Enjoy!
Salient Points Associated with this Consent Decree
The problem started with performance issues associated with the Medtronic SynchroMed Implantable Infusion Pump Systems and an agency warning letter issued to the company’s CEO on July 17, 2012. The warning letter contained multiple observations—and in general, the FDA agreed with Medtronic’s initial response and the actions to be taken to correct the violations. However, the FDA was also very clear, stating that a follow-up inspection would be required to verify the actions taken were appropriate and the violations of the CFR corrected. So what in the heck went so wrong for the Medtronic warning letter to progress down the path toward consent decree?
Typically, the FDA will return for a follow-up inspection, once they receive notice from the device establishment that all activities have been completed. However, the FDA reserves the right to show up on an establishment’s doorstep for a friendly cup of coffee and an inspection at any point in time. For companies under a warning letter’s umbrella, the agency may, and probably will, poke its head into the establishment’s front door and assess the progress made toward corrections. If corrective actions are progressing to plan, the FDA investigator(s) will walk away with a smile on their face. However, if an offending establishment appears to be providing the proverbial lip service, the smile will quickly turn into a frown and potentially a scowl. If the agency is really concerned about the progress (or lack thereof), they will take immediate action to protect the public health (e.g., product injunctions with the help of the federal courts). If the message of compliance coming from the agency continues to fall on deaf ears and the appropriate level of mitigation activities are not being pursued, then the offending establishment’s CJOs will find themselves in the federal courts negotiating the terms of the consent decree and affixing their signatures to it.
According to the Medtronic consent decree, the SynchroMed Implantable Infusion Pump is adulterated because the “facilities or controls, used for their manufacturing, packing, and storage are not in conformity with good manufacturing practices requirement prescribed in 21 CFR, Part 820.” Additionally, there is a basic injunctive provision that prevents Medtronic (directly or indirectly) from designing, manufacturing, processing, packing, labeling, holding, storing, distributing, importing, exporting or performing any other activity ending with an “ing” associated with all SynchroMed devices. Ouch, Ouch, and Ouch again!
Consent Decree – Next Steps
For starters, the good folks working in the Medtronic Accounts Payable Department are about to get a real fiscal workout. One of the outcomes of a consent decree is the selection of a third-party Quality Management Systems Expert(s) capable of helping the offending establishment navigate the often treacherous FDA waters associated with the consent decree. These experts and the firms they represent charge hundreds of dollars for each hour of support. In fact, fully engaged and pursuing mitigation activities to correct all agency observations noted will amount to thousands of dollars of unexpected expenditures each day. The doctor guarantees that the tears of the CFO are going to be real.
What the readers must understand is that once the ink dries on the consent decree, the FDA does not care if the offending establishment enters another medical device into commerce. In fact, the FDA’s only goal is to drive full compliance with regulatory and statutory requirements. The third-party experts will be tasked with performing comprehensive inspections and certifying that the offending establishment has corrected all of the deficiencies previously noted.
Additionally, third-party experts must be retained to perform some of the actual mitigation work. Why? Because if the offending establishment was not able to correct the deficiencies when the original warning letter was issued, chances are they won’t be able to correct them now (yes, some of you may hate Dr. D’s answer; however, the doctor has been there and one that!).
Furthermore, the offending establishment will be required to script a “work plan” and provide a copy of the work plan to FDA for review. Note: this work plan must be provided to FDA within 45 days, upon completion of the initial QMS review/inspection by the third-party expert. The work plan will have a detailed time table. Remember, no work can commence on the activities identified in the work plan until the FDA actually reviews and approves the plan. This agency review can take up to 60 days.
Finally, once the FDA blesses the plan, work can commence. The offending establishment can expect to have the third-party expert(s) in their knickers for months until all deficiencies have been corrected. In fact, activities are not deemed corrected until the third-party expert says the deficiencies have been adequately corrected and notifies the FDA that all work has been completed (a final inspection report certifying that all deficiencies have been corrected) and the FDA performs a re-inspection of the offending establishment(s). However, if the FDA determines that the defendants noted in the consent decree have failed to adequately correct items noted in the decree (or within the allotted time depicted on the work plan), the offending establishment (a.k.a., defendants listed in the consent decree) can be fined up to $15,000 a day for each item that is determined not to be adequately corrected. These fines can be assessed until the FDA believes that all deficiencies have been adequately corrected. The bad news for the CFO(s) is that the cap on fines is currently set at $10 million for each calendar year. That is clearly a significant ouch factor.
For this week’s guidance, the doctor will leave the readers with just one takeaway. There is no such thing as minimum or maximum compliance—there is just compliance. If your establishment is on the receiving end of a Form 483 observation, respond to it quickly and completely. Make sure the mitigation activities mentioned in the response are fully pursued and implemented. If for whatever reason your establishment receives a warning letter, address each of the observations and provide the FDA with a clear and concise plan for mitigation. Do not forget to actually execute the corrections promised to FDA. 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.
Code of Federal Regulation. (2014, April) Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
FDA’s enforcement page. (2012, July). FDA.gov Website. Retrieved May 4, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm314736.htm