The U.S. Department of Justice (DOJ) is reporting that Dr. Thomas Whalen, a rheumatologist who practiced medicine in Havertown, Pennsylvania has pleaded guilty to charges he purchased non-FDA approved, temperature-sensitive biologic medication from Turkey and the United Kingdom to treat his rheumatology patients.
According to the DOJ, Whalen purchased the counterfeit injectable treatments for treating his patients, but led both his patients and Medicare to believe that he was using FDA-approved treatments. Whalen billed Medicare for the drugs he purchased from suppliers in Turkey and the United Kingdom.
Whalen’s felony information sheet describes the drugs he was passing off as FDA-approved: “A biologic is a drug made from complex molecules manufactured using living cells. While most drugs are chemicals synthesized from other chemicals, biologics are much more expensive due to their complex manufacturing process.”
The highly sensitive biologics that he imported included:
- Remicade: An antibody biologic used to treat rheumatoid arthritis, psoriatic arthritis ulcerative colitis, Crohn’s disease and ankylosing spondylitis. Designed to be administered in a doctor’s office by intravenous infusion.
- Orencia: A biologic prescription drug used to treat rheumatoid arthritis. Designed to be administered in a doctor’s office by intravenous infusion.
- Prolia/Xgeva: A pair of biologic prescription drugs used to treat osteoporosis. Designed to be administered in a doctor’s office by intravenous infusion.
- Synvisc and Synvisc-One: Biologic injections specifically for treating knee osteoarthritis. Treatment by injection must be provided by a healthcare professional. Synvisc requires 3 injections, Synvisc-One requires just one.
- Boniva: An injectable prescription drug used to treat osteoporosis. Designed to be administered in a doctor’s office by intravenous infusion.
Whalen also pleaded guilty to supplying oxycodone to patients who were suffering from addiction.
Special Agent in Charge Mark S. McCormack of the FDA’s Office of Criminal Investigations (FDA-OCI), Metro Washington Field Office stated in the DOJ press release: “When health care 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. 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.”