CAMBRIDGE — Owners of Cambridge-based pharmaceutical distributor Safe Chain Solutions Charlie Boyd, Patrick Boyd and Adam Brosius were taken into federal custody after being indicted on charges relating to a counterfeit HIV drug scheme.
According to the federal indictment filed in the U.S. District Court Southern District of Florida, the Boyd brothers and Brosius — also the owner of Worldwide Pharma Sales — have each been charged with:
One count of conspiracy to introduce adulterated and misbranded drugs and to defraud the United States.
Two counts of introducing a misbranded drug into interstate commerce.
One count of conspiracy to traffic in medical products with false documentation.
One count of conspiracy to commit wire fraud.
Three counts of committing wire fraud.
The indictment alleges that the defendants conspired to defraud the U.S. by “impairing, impeding, obstructing and defeating” the functions of the U.S. Food and Drug Administration.
It says the defendants did this by purchasing large amounts of diverted prescription drugs, including HIV drugs at “steeply discounted prices” and reselling them to pharmacy customers without or with falsified required-by-law product tracing information, also known as T3s or pedigrees.
Diverted prescription drugs are drugs that were removed from regulated distribution channels and reintroduced in the wholesale marketplace. According to the indictment, common methods of diverting prescription drugs include obtaining them illegally through fraud or from patients that have been prescribed the drugs but intentionally did not consume them.
The indictment also alleges the defendants redistributed bottles of prescription drugs from HIV drug suppliers that contained a different drug than the HIV drug on the label. It says the defendants were made aware of this but continued to buy and sell the drugs obtained from the HIV drug suppliers.
In an Aug. 14, 2020, text message, which is included in the indictment, Charles Boyd told Patrick Boyd, “Patient opened a bottle and it was different medication,” and in another text on the same day said, “It was replaced with bipolar med.”
The Boyds also received emails from Safe Chain’s director of compliance confirming that information contained in certain pedigrees was false and telling them that this should be reported to the FDA, according to the indictment.
Regarding the wire fraud charges, the indictment alleges the defendants sent more than $90 million in payments to HIV drug suppliers for adulterated, misbranded and diverted prescription drugs through interstate wire transmissions. It says these transmissions occurred from in or around May 2020 through in or around July 2021.
The indictment alleges the defendants and their co-conspirators then used the proceeds from this scheme for their own use and benefit, the use and benefit of others and the continuance of fraud.
In June 2023, the FDA issued a warning letter regarding Safe Chain’s violations of the Drug Supply Chain Security Act following a monthlong inspection of the Cambridge facility in spring 2022.
The letter said the company did not have adequate verification systems that “may have resulted in suspect product entering the supply chain.” It also confirmed that Safe Chain purchased products from other drug wholesalers that were not authorized, failed to maintain records of suspect product investigations and failed to respond to notifications of illegitimate products.
In February, the company reached a settlement with Gilead Sciences Inc., a biopharmaceutical company that develops and markets a variety of medications, after over two years of civil litigation.
Gilead’s complaint alleged Safe Chain’s involvement in the distribution of authentic-looking bottles of two of Gilead’s HIV medications, Biktarvy and Descovy, to pharmacies across the country.
In April 2022, Janssen Sciences, the pharmaceutical arm of multinational corporation Johnson & Johnson, also filed a federal complaint accusing Safe Chain of distributing large quantities of counterfeit Janssen HIV medications.
Neither Safe Chain nor the Department of Justice responded to multiple requests for comments before the publishing of this article.
The defendants were taken into federal custody on June 14. If convicted, the defendants will have to forfeit any property traceable to their offenses, according to the indictment. They each could face up to 106 years of jail time and millions of dollars in fines.
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