Deputy Assistant Attorney General Arun G. Rao Delivers Remarks at the Jefferson Literary and Debating Society’s Distinguished Speaker Series
A federal court entered a consent decree of permanent injunction against defendants Pharm D Solutions LLC (Pharm D); Luis R. De Leon, co-owner and Pharmacist-in-Charge; and Juan C. De Leon, co-owner and pharmacist, the Department of Justice announced today. The injunction permanently enjoins the defendants from distributing adulterated, misbranded, and unapproved new drugs in violation of the federal Food, Drug, and Cosmetic Act (FDCA).
The Department filed a complaint in the U.S. District Court for the Southern District of Texas on May 20, 2019, at the request of the U.S. Food and Drug Administration (FDA), alleging, among other things, that the defendants failed adequately to address insanitary conditions at their drug-compounding facility.
As part of the ordered permanent injunction, defendants cannot resume manufacturing, processing, or distributing sterile drugs until FDA determines that they have complied with specific remedial measures. Those measures seek to ensure that defendants manufacture and distribute drugs in conformity with applicable manufacturing standards.
“Compounding pharmacies must produce drugs that are reliably safe and sterile,” said Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division. “The Department of Justice will continue to work closely with FDA to enforce the provisions of the Food, Drug, and Cosmetic Act.”
“The Food, Drug, and Cosmetic Act is designed to protect the public health,” said U.S. Attorney Ryan K. Patrick for the Southern District of Texas. “Our district is a committed partner in enforcing the provisions of the Act in the interest of public safety.”
“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,” said Acting FDA Commissioner Ned Sharpless, M.D. “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, defendants’ drugs were adulterated because they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated or may have been rendered injurious to health. For example, the complaint alleges that during a 2018 FDA Inspection, defendants’ employees failed to demonstrate proper aseptic technique by, among other things, leaning into sterile areas with exposed skin and failing to maintain clean air supply when handling products intended to be sterile. The complaint further alleges that defendants failed to appropriately investigate instances of microbial contamination, mold, and yeast recovered from sterile processing areas.
Pharm D initiated a voluntary recall of all compounded drug products intended to be sterile after the September 2018 FDA Inspection raised concerns about practices at the pharmacy. Pharm D also temporarily ceased sterile production at that time.
The government is represented by Trial Attorney Raquel Toledo of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Melissa M. Green of the U.S. Attorney’s Office for the Southern District of Texas, with the assistance of Associate Chief Counsel, Enforcement, Samantha Hong of the Department of Health and Human Services’ Office of General Counsel.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at https://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Southern District of Texas, visit its website at https://www.justice.gov/usao-sdtx.