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Regulatory News | 09 December 2022 | By Joanne S. Eglovitch
FDA's Jill Furman
Updated 12 December to reflect correct acronym for FDA's Office of Compliance*
A top official with the US Food and Drug Administration’s (FDA) Office of Compliance (OC) reflected on some of the top trends that drove the agency’s compliance actions in 2022 at the Food and Drug Law Institute’s (FDLI) annual enforcement meeting on 7 November.
“Adverse events and safety issues drive our work,” said Jill Furman, acting director of FDA's Center for Drug Evaluation and Research's (CDER) Office of Compliance, who is temporarily filling the position vacated by Donald Ashley in October 2022 (RELATED: This Week at FDA: Calif considering diagnostic reform rulemaking, Ashley says goodbye, Regulatory Focus, 28 October 2022).
Furman’s remarks addressed noncompliance issues in the manufacturing and unapproved drugs area, which represents an area of the CDER Compliance's work remit. FDA also has jurisdiction over the supply chain and the Drug Supply Chain Security Act, recalls, compounding, clinical trial oversight, labeling violations, fraud, and drug listing and registration requirements.
PharmaTech ignored problems and lied to investigators
In the manufacturing area, Furman described how one firm’s CEO landed in serious trouble this year after sweeping contamination problems under the rug and then lying to investigators that problems had been fixed.
Florida-based PharmaTech was a drug and dietary supplement manufacturer that made Diocto Liquid, an oral solution drug used in hospitals to treat constipation.
FDA conducted an inspection after being made aware of an outbreak of Burkholderia cepacia tied to patients who were administered the drug at several hospitals. FDA found that the sample taken from the firm’s water system had tested positive for the presence of the bacterium and issued a notification for healthcare providers to stop using the product (RELATED: FDA Warns of Bacterial Contamination in PharmaTech Liquid Drugs, Regulatory Focus, 9 August 2017)
In response, the firm’s CEO Raidel Figueroa falsely told investigators that the company had reengineered its water systems and that the problem was fixed, said Furman.
During its investigation, FDA asked the company in March 2017 to disclose all products made at the facility. Figueroa “lied to investigators and excluded this product from the product list,” Furman said. He also lied to investigators about his ownership of two other manufacturing facilities.
The firm’s failure to deal with the contamination resulted in three deaths in hospitals across numerous states.
In June 2022, Figueroa was sentenced in June to 37 months in prison for his role in hiding the contamination problem.
She said this case was “one of the most egregious violations that we have seen in CDER compliance in years.”
Morton Grove repeatedly ignored problems, backdated records
Furman also described a case where a firm’s refusal to address manufacturing violations flagged by investigators led to the Department of Justice issuing an injunction order against the firm in August 2022. DOJ filed an injunction order against Morton Grove Pharmaceuticals for ignoring quality problems raised in FDA warning letters. The company, a subsidiary of Wockhardt, makes OTC and generic drugs.
Furman said that “FDA had inspected the firm a number of times and there were repeat violations at the firm, including batch failures, and failure to address laboratory controls, and to sterilize equipment properly.” FDA also had “serious concerns” related to the backdating of microbial test results “which called into question the validity of all the test results at the site.”
Noncompliance persisted despite numerous warnings from the agency. Furman said that “there was a total lack of oversight of the quality issues by the management,” (RELATED: FDA Warns Wockhardt Subsidiary, Says Seven of Company’s Facilities Out of Compliance, Regulatory Focus 8 March 2017).
Agency addressing unapproved products
In other areas, FDA has also taken enforcement actions in the unapproved drugs area. One example is a recent warning letter sent to Amazon for selling drugs with undeclared active ingredients (RELATED: FDA sends warning letters to Lupin, Amazon and Walmart, Regulatory Focus, 1 November 2022).
The office is also "focused on getting hidden drug ingredients in approved drugs off the market,” Furman said.
The drugs sold by Amazon were advertised to help reduce joint pain, yet FDA received “numerous adverse events” for these products.
FDA also issued 12 warning letters to companies for selling unapproved mole removal products after receiving reports of “serious side effects and adverse events” for these products.
The agency also issued a warning in May 2022 advising consumers not to use products containing delta-8 tetrahydrocannabinol (delta-8 THC). She said that “these products can be dangerous.”
According to FDA, “Delta-8 THC has psychoactive and intoxicating effects…. The FDA has received reports of adverse events experienced by patients who have consumed these products.”
* A previous version of the story used an incorrect acronym for FDA's Office of Compliance. It is OC, not OCC. Regulatory Focus regrets the error.
Tags: Compliance, FDA, FDLI