My dear readers, once again there was not much cannon fodder to be found during the doctor’s weekly visit to the FDA’s Warning Letter Page, so similar to last week’s Devine Guidance, Dr. D will improvise with more interesting tidbits extracted from the United States Department of Justice’s (DOJ) Press Releases. Many of the readers are familiar with the trials and tribulations of two former Acclarent executives and the introduction of misbranded and adulterated products into interstate commerce to drive revenue. William Facteau, 47 (former CEO and now the soon to be a Chief Jailable Officer (CJO) possibly doing some time for the crime) and Patrick Fabian, 49 (former vice president of sales and possibly Facteau’s soon-to-be cell mate) were convicted by a jury of their peers on 10 counts of introducing adulterated and misbranded medical devices into interstate commerce. For what it is worth, the trial lasted six weeks. According to the DOJ press release: “The evidence at trial demonstrated that Facteau and Fabian sought to quickly develop and market products, including the Stratus as a drug delivery device, to create a projected revenue stream that would make Acclarent an attractive business for either an initial public offering or acquisition.” Hopefully, these two gentlemen have not established some sort of usufruct (look-it-up) for their profits, because Dr. D thinks the Feds are going to take some serious coin away from these gents. For Dr. D’s readers with inquiring minds, the penalty for each count of violating the Food, Drug and Cosmetics Act is a maximum sentence of one year in prison, one year of supervised release, and a fine of $100,000 or twice the gross gain or loss. Enjoy!

Dr. D’s Disclaimer: Although convicted in the Federal Courts by a jury of their peers, sentencing has not occurred. Jail time and fines will be determined during the sentencing phase of the trial.

Extraction from DOJ Press Release – July 20, 2016

“The jury concluded that Facteau and Fabian caused the unlawful distribution of a medical device known as the Relieva Stratus Microflow Spacer (“Stratus”) for uses not cleared or approved by the U.S. Food and Drug Administration.  Despite the fact that the company had told the FDA that the Stratus was a medical device intended to maintain an opening to a patient’s sinus, Facteau and Fabian launched the product intending it to be used as a steroid delivery device.  The FDA, however, had specifically refused Acclarent’s request to clear the Stratus for marketing as a drug delivery device without further submissions to support that use.”

“The evidence at trial demonstrated that Facteau and Fabian sought to quickly develop and market products, including the Stratus as a drug delivery device, to create a projected revenue stream that would make Acclarent an attractive business for either an initial public offering or acquisition.”

Compliance for Dummies

On a positive note for the defendants, they were acquitted of the more serious felonies (14 counts). However, the jury found the defendant’s guilty of 10 misdemeanors. There is a significant moral story that every professional can learn from this week’s guidance. Profits placed before patient safety or tempting fate by ignoring the U.S. Food, Drug, and Cosmetic’s Act is always going to end badly for CJOs. The FDA will typically fire one warning shot across the proverbial bow of an offending establishment in an effort to stop the violative practices. Astute CJOs and their establishments take the agency’s message to heart and stop the offending behavior immediately. However, to intentionally violate The Act, in pursuit of financial rewards, well, Dr. D would rather take his chances in a cave with a sharp stick and a sleeping bear.

The requirements for obtaining device clearance (Class II) through the 510(k) process or device approval (Class III) through the PMA process is spelled out in black and white in the various CFR’s (e.g., 21 CFR, Parts 807 and 814). The same holds true for Class 1 devices, which still require listing on the FDA Unified Registration and Listing System (FURLS) database. These regulatory pathways are premised on device risk and have been painstakingly developed to ensure product safety and efficacy is maintained while protecting the public health. People, there is never going to be negotiation between offending device establishments and the public health, which the FDA is entrusted to protect, when it comes to device safety and efficacy.

Takeaways

For this week’s guidance there are three takeaways. One: It is not nice to anger the regulatory gods at FDA. Profits should never come before patient safety and efficacy. Two: If the agency says “no” then “no” means “NO.” It doesn’t mean we will think about it and get back to you. Three: All medical devices must be appropriately identified by class, cleared or approved prior to being entered into commerce in the United States, period! The ramifications and penalties for violating The Act are severe, just ask Facteau and Fabian. In closing, thank you again for joining Dr. D, and I hope you found 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. (July 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Former Acclarent, Inc. executives convicted of crimes related to the sale of medical devices. Accessed August 14, 2016. Retrieved from http://www.fda.gov/ICECI/CriminalInvestigations/ucm512507.htm