A Pennsylvania doctor pleaded guilty Tuesday to fraud and drug importation charges for illegally importing medications not approved by the Food and Drug Administration (FDA) and administering them to his patients.
Rheumatologist Thomas J. Whalen, D.O., 65, of Havertown, pleaded guilty to one count of healthcare fraud, one count of importation contrary to law and two counts of distribution of controlled substances, according to the Department of Justice (DOJ). He also pleaded guilty to unlawfully distributing oxycodone to his patients.
Whalen’s guilty plea came a day before the Trump administration unveiled plans to allow states to buy and import cheaper drugs from Canada. The Trump administration Wednesday proposed a new pilot project to enable states to import drugs from Canada and that would enable drug companies to voluntarily import their products.
Under a proposed rule by the Health and Human Services Department and FDA, states and non-federal government entities would apply to the FDA to import certain prescription drugs from Canada. The drugs must be approved in Canada and certain types of drugs are not eligible, including controlled substances, biologics and intravenously injected drugs.
However, the charges against Whalen stemmed from his importing and using non-FDA-approved drugs from Turkey and the United Kingdom, said William Walker, acting special agent in charge of the U.S. Immigration and Customs Enforcement’s Homeland Security Investigations (HSI) division in Philadelphia.
Additionally, Whalen prescribed painkillers to patients already struggling with addiction, Walker said.
Sentencing is scheduled for April 1. Whalen faces up to 70 years of imprisonment and a $2.5 million fine, according to the U.S. Attorney’s Office for the eastern district of Pennsylvania.
In pleading guilty, Whalen admitted that he illegally imported non-FDA-approved medications from about January 2014 through March 2018, the DOJ said. Those medications included Remicade, Synvisc, Synvisc-One, Orencia, Prolia/Xgeva and Boniva.
Whalen owned and operated Whalen Rheumatology Group with locations in Havertown, Exton and Wilmington, law enforcement officials said. As part of his practice, he used expensive medications made of living cells, administered by injection and infusion. Rather than purchase FDA-approved versions of the medications from authorized distributors, he purchased much cheaper, non-FDA-approved foreign versions, they said.
His patients were unaware he was injecting or infusing those drugs and he then falsely billed federal healthcare benefit programs approximately $2.3 million, billing as though he had used FDA-approved medicines, officials said. Whalen was paid directly approximately $1.1 million and pocketed the profits for himself.
“When healthcare professionals import unsafe, untested prescription drugs from outside the drug supply chain that the FDA oversees, the American public's health and trust are jeopardized,” said Mark S. McCormack, special agent in charge of the FDA’s Office of Criminal Investigations in the Metro Washington Field Office. “The FDA is committed to pursuing and bringing to justice those who attempt to subvert the safeguards of our closed drug supply by distributing unapproved products.”
Whalen also admitted to unlawfully distributing oxycodone to patients outside the course of his professional practice and without a legitimate medical purpose. In the case of two patients, Whalen prescribed oxycodone despite knowing from patients’ urine drug screens they were using illicit drugs, including heroin and cocaine, according to law enforcement officials.