Co-founder of Florida pharma indicted after multistate bacterial outbreak at children's hospitals
The former CEO of a Florida pharma has been charged with defrauding the FDA and distributing adulterated drugs by the US Department of Justice.
Raidel Figueroa has been indicted with conspiracy to defraud the United States, falsification of records in a federal investigation, obstruction of proceedings before an agency of the United States, and distribution of adulterated drugs in interstate commerce.
Charges stem from a two-year stretch in which Pharmatech, the Broward County, Florida company Figueroa co-founded, manufactured and distributed the stool softener Diocto Liquid through an outbreak of Burkholderia cepacia, a complex group of bacteria that can pose a risk to those who are patients with weakened immune systems or chronic lung disease.
After a water sample tested positive in 2016, Pharmatech was asked to disclose all of the medicines it had made after it resumed manufacturing. The DoJ alleges that Figueroa left Diocto Liquid from the product list, despite the fact that his company had shipped 7,000 units of the drug that month.
Then just months after those doses were shipped, there were “multiple cases of B. cepacia infections in pediatric patients at Stanford Children’s Health Lucile Packard Children’s Hospital in Palo Alto, California and Johns Hopkins Children’s Center in Baltimore, Maryland,” the indictment says. After the FDA collected bottles of Diocto Liquid from the medical centers, it found that several of the bottles contained total aerobic microbial counts, yeast and mold counts over acceptable limits, while other bottles also tested positive for the presence of B. cepacia.
“We speculate that B. cepacia might have colonized and infected infants via aspiration of enteral fluids, translocation across the enteric mucosa or migration into the genitourinary tract from the gastrointestinal tract, putting the most critically ill patients at highest risk,” an NIH paper published on the outbreak stated. “Despite early identification of a bacterial strain different from that implicated in previously recalled products, outbreak investigators should maintain a high level of suspicion and use NDC codes to identify common products or manufacturers.”
Figueroa also told the FDA that his company was re-engineering the purified water system to prevent contaminations in the future, according to the indictment. He later said that the new system met the acceptance criteria, which the FDA said is not true.
The bacteria is resistant to common antibiotics, the Justice Department says. At least one family has sued Pharmatech. Pittsburgh residents Lamont Singleton and Jocelyn Wilson said their daughter Alivia died before she turned a year old from a bacterial infection contracted from taking Diocto Liquid.