U.S. authorities have accused two CANARX executives of involvement in the long-running illegal import of prescription drugs. Finance chief and director John Thomas Howard was arrested Sunday and faces charges including smuggling and conspiracy. His brother, company president and director Bob Howard, remains wanted in the federal investigation. The case puts renewed focus on the legal limits of employer-sponsored overseas drug programs and on prescription drug supply-chain security.
John Thomas Howard arrested on multiple charges
Court documents filed Tuesday show that John Thomas Howard is charged with smuggling and conspiracy. His arrest warrant also lists charges of introducing misbranded drugs into interstate commerce and illegally importing drugs. He has not yet entered a plea.
In an affidavit, Dustin Dobbs, a special agent with the U.S. Food and Drug Administration’s Office of Criminal Investigations, said investigators believe there is probable cause to conclude that CANARX illegally imported prescription drugs or helped bring them into the country. The affidavit does not identify the drugs under investigation. The criminal complaint covers the period from February 22, 2017, through April 15, 2026. Bob Howard has not been taken into custody.
CANARX general counsel Joseph Morris said the brothers deny all allegations and will contest the charges, adding that they believe they will be vindicated in court.
CANARX supplied drugs through employer health programs
Founded in 2002 and based in Windsor, Ontario, CANARX describes itself as an international prescription drug supply service for the U.S. market. Its website says the company sources medicines from Canada, the United Kingdom, Australia and New Zealand.
The company has appeared in alternative funding programs, or AFPs, used by employer health plans. These programs arrange access to costly specialty drugs through employers, and some employers require participating workers to obtain their medicines through the program.
Such programs typically source drugs overseas and ship them directly to patients. The FDA has said that the practice may involve unlawful imports and raise drug-safety concerns. The central dispute over AFPs is whether prescription drugs can be imported for personal use in the United States. The agency allows personal imports in certain circumstances, including when a drug is unavailable in the U.S., but has said that people generally cannot import foreign prescription drugs to replace FDA-approved medicines.
FDA seized CANARX shipment and issued warning letter
CANARX has been under FDA scrutiny for several years. In 2023, the agency seized a shipment of drugs sent by the company, saying the products might be misbranded or counterfeit. In a 2019 warning letter, the FDA said CANARX’s operations substituted unapproved drugs for FDA-approved medicines prescribed by U.S. health care providers.
Morris said at the time that CANARX had not misled patients, but agreed to stop importing drugs that require administration by a physician. In an interview last year, he said medicines sent to U.S. patients came from highly regulated countries and described the company’s business as legal. The affidavit in the current criminal case does not disclose the drugs involved or details of the supply chain.
Gilead lawsuit separately targets Biktarvy imports
In a separate civil lawsuit that remains unresolved, Gilead Sciences accused CANARX and other companies of illegally importing Biktarvy, its HIV treatment. CANARX has not responded to the lawsuit. Gilead said it brought the case to protect patients and the U.S. drug supply chain, and to support government action against conduct that could put patients at risk.
The criminal allegations are still subject to court proceedings, and the investigation documents do not name the drugs at issue. CANARX denies wrongdoing by its executives. The criminal case and Gilead’s civil lawsuit are proceeding separately, with the facts and legal questions in both matters still to be determined.