FDA urged to probe naltrexone implant tests on prison inmates

A corrections department spokeswoman told The Baton Rouge Advocate in May that the first inmate had received the implant through the voluntary program at the Louisiana State Penitentiary in Angola. (Wikimedia Commons)

The FDA is being urged to investigate California biotech BioCorRx amid claims that it tested an unapproved drug implant for dependency on prison inmates without institutional oversight or thoroughly gathered legal consent.

The advocacy group Public Citizen said a pilot project at the company—originally planned for 10 inmates housed within the Louisiana prison system—involved a long-lasting formulation of the anti-addiction therapy naltrexone as a biodegradable implant that slowly releases the drug over 90 days. Naltrexone has previously received U.S. approvals for treating opioid and alcohol dependence as a tablet and injection.

The project was ended soon after it was announced in May following criticism, according to Public Citizen—but the group says BioCorRx may still be conducting trials elsewhere in the U.S. that may be in violation of regulations governing testing in human subjects.

The company has previously described programs for testing the naltrexone implant, including as a potential weight loss therapy in 2017 in Silver Spring, Maryland, as well as a 2018 collaboration with the One Day at a Time Program for homeless and low-income individuals, which is funded by the city of Philadelphia and state of Pennsylvania.

After the Louisiana project was announced earlier this year, BioCorRx CEO Brady Granier told The Baton Rouge Advocate that the implant had been used in at least 1,000 people. Additionally, a corrections department spokeswoman confirmed that the first inmate had received the implant through the voluntary program.

In its letter (PDF) to the FDA, co-signed by 31 doctors, prison advocates and academics, Public Citizen called for a formal compliance investigation. Though the company described the pilot program as not a clinical study, it also said it planned to collect data from inmates to monitor the implant’s performance, according to the group.

“BioCorRx welcomes any investigation by the FDA and believes it has done everything regarding its comprehensive program to fight addictions in full compliance with the letter and spirit of the law,” a company spokesperson said in a statement to FierceMedTech.

“Naltrexone implants have been utilized by countless medical doctors under their discretion with their patients for over 20 years in the U.S. under the constantly changing pharmacy compounding guidance and from several licensed compounding pharmacies; long before the existence of BioCorRx,” the company added.

“That guidance is complex and continues to evolve since the Drug Quality Act was signed by President Obama in November 2013. While we take this matter seriously, we hope it ultimately leads to more people getting the help that they need regardless of the modality.”

Public Citizen also called on the FDA to inspect the compounding pharmacies used by the company for its sustained-release implants to make sure they are sterile and deliver the intended strength of the drug. The group also asked the agency to determine whether the drug delivery implant is also considered a medical device and subject to additional regulations.