2019 FDA Enforcement and Related Litigation Trends (Part 2)

Yesterday, we covered some 2019 stats regarding FDA’s inspections and Warning Letters, and discussed a few specific trends we saw last year. In Part Two of our series, we look at the specifics of FDA’s 2019 consent decrees.

 FDA Consent Decrees

FDA published press releases about six consent decrees in 2019.  As discusssed in Part One, compounding facilities were a focus of FDA enforcement in 2019, and this focus included entering consent decrees, with four of the six consent decrees in 2019 entered against compounding facilities.

On February 6, 2019, the U.S. District Court for the Western District of Pennsylvania entered a consent decree between the United States and Ranier’s Rx Laboratory Inc., and owner Francis H. Ranier for manufacturing purportedly sterile drug products in insanitary conditions.  When announcing the consent decree, then-Commissioner Gottlieb stated, “We continue to see concerning activity when it comes to some compounded drugs, including problems related to the conditions under which compounded sterile medicines are made, which can raise significant risks to patients.  This is an area of intense focus for FDA.  We’re committed to making sure that compounded drugs are made under appropriate production standards and, when necessary, taking enforcement actions against compounders who fail to produce sterile drugs in compliance with the law.”   

On March 12, 2019, the U.S. District Court for the Northern District of Texas entered a consent decree against Guardian Pharmacy Services and owner Jack Munn.  When announcing the consent decree, Commissioner Gottlieb again confirmed FDA’s enforcement focus on compounding facilities, stating, “Although compounded drugs can serve an important role for certain patients whose medical needs cannot be met by an FDA approved drug product, compounded drugs can also pose unique risks.  They’re not FDA approved and do not undergo premarket review for safety, effectiveness or quality.  All drug compounders must comply with certain requirements, which can include current good manufacturing practice requirements, to avoid product quality problems and potential patient harm.”  According to the complaint, Guardian manufactured and distributed purportedly sterile drug products that were manufactured under insanitary conditions.  Additionally, Guardian’s labels were false or misleading and did not include adequate directions for patient use. 

On May 22, 2019, the U.S. District Court for the Southern District of Texas entered a consent decree against Pharm D Solutions, LLC, and owners Luis R. De Leon and Juan C. De Leon.  When announcing the consent decree, Acting Commissioner Sharpless stated, “We understand that compounded drugs can be important for patients whose medical needs cannot be met by FDA-approved drug products, and we’re continuing efforts to advance policies to help further improve the quality of compounded products. . . .  These drugs are not approved by the FDA and have not been evaluated for safety or efficacy, so when they’re not appropriately compounded, they have the potential to cause patients harm.  We’ll continue taking enforcement actions, like the one we’re taking today, to ensure that these companies and products do not put patient health at risk.”  According to the complaint, Pharm D Solutions manufactured and distributed drugs that were made under insanitary conditions, had strengths different from what they were represented to possess, and did not include adequate directions for use. 

Also on May 22, 2019, the U.S. District Court for the Northern District of Illinois entered a consent decree against PharMedium Services and president and vice president Scott Aladeen and Warren Horton for violations at multiple facilities including manufacturing drugs under insanitary conditions and failing to include adequate directions for use.  When announcing the consent decree, Acting Commissioner Sharpless stated, “We will continue to take appropriate actions when compounding pharmacies and outsourcing facilities produce drugs under substandard conditions or use inappropriate practices that could lead to serious harm to patients.”

The other two consent decrees were entered on July 18, 2019 and September 3, 2019, respectively, against an Arkansas food and medical product grocery warehouse, J and L Grocery, LLC, for insanitary conditions, and Tennessee drug, dietary supplement, and device distributors Basic Reset and Biogenyx, for distributing unapproved drugs and devices, failing to comply with CGMPs for dietary supplements, and distributing dietary supplements with incomplete labeling. 

Check back tomorrow for Part Three of our series, where we’ll take a look at some of the Department of Justice enforcement trends in 2019.