June 12, 2023: FDA reports show the agency working hard to secure our drug supply.
This week: In 2022, the FDA increased inspections of manufacturing facilities 44% and prevented 222 drug shortages. Men in Colorado and Virginia were sentenced for distributing unapproved prescription drugs. 22 states reported drug seizures and prosecutions related to deaths from and trafficking of counterfeit pills made with fentanyl, methamphetamine and xylazine.
National News
The FDA releases annual reports to Congress. Dedicated family advocates continue to educate about counterfeit pills.
Recent reports from the U.S. Food and Drug Administration (FDA) to Congress offer a glimpse into how actively the agency works to ensure Americans have access to the medicines they need.
FDA headquarters, Silver Spring, Maryland (Flickr)
Shortly after the U.S. experienced a record 250 drug shortages in 2011, the FDA began to issue annual reports tracking the issue. The Tenth Annual Report on Drug Shortages shows that while the U.S. did experience 49 drug shortages in 2022, improved early communication with the pharmaceutical industry allowed the FDA to prevent 222 drug shortages during the same timeframe.
FDA’s Annual Report on Inspections of Establishments for 2022 shows the agency’s recovery from pandemic disruptions, with routine site visits increasing 44% over 2021. Inspectors verified current good manufacturing practices (CGMP) at 2,442 of 58,801 registered facilities making finished medicines, ingredients and devices for the U.S. market, including 13% of foreign sites making drugs and devices.
Family advocates in North Carolina, South Carolina, and Washington spoke about the dangers of fentanyl, sharing stories about loved ones who died after taking counterfeit pills.
Prosecutions
Cases involving illegally imported prescription painkillers, sedatives, and injected hormones; fentanyl, methamphetamine and xylazine pills; and pill presses in 16 states and Washington D.C.
John Gentile of Arvada, Colorado was sentenced to two years of probation for conspiring to distribute illegally imported prescription drugs. From January 2020 through 2021, Gentile received controlled substance medicines such as tramadol, alprazolam and zolpidem from a drug supplier in India and repackaged and shipped them to customers in the United States. Investigators found 17,500 pills in Gentile’s vehicle when they arrested him in March 2022.
Jonathan Corbett Cosie of Chesterfield, Virginia pleaded guilty to two counts of introducing a misbranded drug into interstate commerce after he sold customers human chorionic gonadotropin (hCG) injections for weight loss without a prescription. Cosie, who ran a supplement business, claimed that the hCG came from international pharmacies, but he actually sourced the hormone from foreign manufacturers, then labeled the vials with false and misleading information. HCG requires a prescription in the U.S., and has not been approved for weight loss.
A pill press seized from Jose Garnica's residence in July 2022. (U.S. Attorney's Office, Western District of Washington)
Jose Eduardo Garnica of Marysville, Washington received a 15-year prison sentence for running a fentanyl pill manufacturing lab in his rental home. Garnica came to the attention of law enforcement in June 2022, when U.S. Customs and Border Protection (CBP) officers in Los Angeles intercepted a package labeled “furniture parts,” that contained pill press dies for oxycodone pills. When investigators searched Garnica’s home in July 2022, they found a pill press, 25 kilograms of fentanyl, 27 guns and 50,000 rounds of ammunition. Some of the pills Garnica made also contained xylazine – a veterinary drug that was recently subject of a DEA public safety alert.
Gerardo Corrales-Aragon was sentenced to 150 months in federal prison for his role in distributing the counterfeit oxycodone pills made with fentanyl that killed a Hillsboro, Oregon man in February 2021. Corrales-Aragon transported the counterfeits from California to Oregon and provided them to the Hillsboro victim’s dealer.
Juan Carlos Perez of Fort Worth, Texas received a ten-year prison sentence after pleading guilty to selling methamphetamine and counterfeit pills made with methamphetamine.
Michael Wayne Lee of Blaine, Tennessee was sentenced to 87 months for arranging the delivery of fake oxycodone pills made with fentanyl to the Northeast Correctional Complex, Carter County Annex while he was an inmate there. The pills, which were delivered inside tennis balls thrown over a fence into the facility’s recreation yard, led to the hospitalization of one inmate and the death of another.
Stefano Saienn of Wilmington, Delaware was sentenced to 90 months in federal prison for distributing fentanyl after selling counterfeit oxycodone pills that killed Bear resident William H. Ebert, IV in May 2022.
Peabody, Massachusetts resident Manuel E. Tejeda pleaded guilty to a drug charge. Investigators caught him with 27,000 fentanyl pills and two kilograms of suspected fentanyl and/or heroin, $150,000 in cash and an industrial/commercial grade pill press in his storage unit in Salem in January 2020.
California resident Matthew J. Gomez pleaded guilty to smuggling more than 33,000 counterfeit pills that contained nearly four kilograms of fentanyl on a bus traveling through Kansas City, Missouri from Los Angeles, California.
The U.S. Attorney's Office in the Western District of Pennsylvania unsealed an indictment naming 58 defendants, many of whom are allegedly are part of an Erie, Pennsylvania street gang, for violating federal racketeering, narcotics, and firearm laws by trafficking a variety of drugs, including more than 150,000 fentanyl pills in Erie and elsewhere.
People were also convicted or sentenced in cases involving counterfeit pills made with fentanyl or methamphetamine in Tempe, Arizona; Mundelein, Illinois; Peabody, Massachusetts; Maple Grove, Minnesota; Roanoke, Virginia; Green Bay, Wisconsin and Casper, Wyoming.
Defendants were charged with selling counterfeit pills made with fentanyl that led to illness or fatalities in St. Paul, Minnesota; Sedalia, Missouri; Albuquerque, New Mexico; Portland, Oregon; Toledo, Washington; Grand County, Utah and Washington, D.C.
Seizures
Counterfeit pills in 10 states and Windsor, Canada.
Arkansas State Police seized 50,000 fentanyl pills during a traffic stop in Little Rock.
Police recovered 45,000 fentanyl pills, methamphetamine, crack, firearms and cash during a drug bust in Albuquerque, New Mexico.
The Oklahoma Bureau of Narcotics seized 14,000 fentanyl pills and ten pounds of heroin while concluding a 16-month-long investigation.
There were also counterfeit pill seizures in Northridge and Ventura County, California; Lewiston, Idaho; Middletown, Indiana; Harrisburg, Pennsylvania; Portland, Oregon; Lancaster, Pennsylvania; Pendleton, South Carolina; Clarkston, Washington; Worland, Wyoming and Windsor, Canada.
Counterfeit anti-anxiety pills mimicking clonazepam and several kinds of alprazolam. Seized in Clarkston, Washington, June 2023. (Quad Cities Drug Task Force)