Healthcare practitioners should be aware of recent investigations and prosecutions for the purchase and distribution of non-FDA-approved narcotics from outside the U.S. Recent reports of U.S. Federal Drug Administration (“FDA”) activity puts a spotlight on not only the civil and criminal penalties at stake, but also the safety of patients. Concerned physicians and health care administrators and staff should be aware and vigilant against even unintentional acquisition of prohibited narcotics. Negligence is not a defense to liability for breaking these laws. Healthcare practitioners and professionals risk the suspension and loss of their licenses in connection with prescription drugs coming from foreign countries.
State and federal agencies are investigating and prosecuting the acquisition and distribution of non-FDA-approved medications.
A currently circulating news story is catching the attention of healthcare practitioners targeted by foreign supplies of medications not approved by the FDA. The Physician’s Practice website recently published an article focused on importing foreign prescription drugs[i]. The FDA’s focus on doctors who thought they purchased Avastin, a cancer drug, from an online Canadian pharmacy. The imported medication was fake and, “contained cornstarch and acetone, but no active cancer fighting ingredients,” the article reports. “Patients who received the false medication did not receive the cancer-fighting medications they truly required.”
Doctors, hospital administrators and staff should all be concerned about the risks of foreign prescriptions. The civil and criminal penalties are strict and professionals’ licenses are on the line for violations of the laws involved. While a doctor may save up to 50 percent on the cost of a medically equivalent drug from Canada or Ireland, making that purchase can lead to a drug trafficking conviction.
The importation of non-FDA-approved drugs is a violation of the Federal Food, Drug, and Cosmetic Act (“FDCA”) which is enforced by the FDA. The FDA can prosecute a first offense of importing a non-FDA-approved drug resulting in either or both a year in prison and up to a $1,000 fine; a second offense can earn a three year sentence and up to $10,000 fine.[ii]
The Illinois Department of Financial and Professional Regulation (“IDFPR”) can suspend or revoke a professional license to practice for violations of the FDCA.
The Illinois Medical Practice Act of 1987 (“MPA”)[iii] sets for the law concerning the activity of licensed healthcare practitioners. The mission of the IDFPR is, “To serve, safeguard, and promote the public welfare by ensuring that licensure qualifications and standards for professional practice are properly evaluated, accurately applied and vigorously enforced.[iv]” The IDFPR can suspend or revoke a professional’s license for violations of the MPA. On their website, the division published a news release with helpful information, How the Division Responds to a Request for an Investigation of a Physician.
Being proactive and vigilant with everyone involved is a best practice to protect against foreign drugs.
Doctors and their administration and staff should be made aware of the risks of overseas prescription medication sales and the consequences for violations of state and federal laws. It may be helpful to identify the online and offline sellers attempting to lure in American purchasers with the promise of big savings and more. Being proactive and educating healthcare professionals about the risks and penalties of purchasing non-FDA-approved drugs from overseas is a recommended practice.
For more information about professional licensing and what to do upon receiving notice of a complaint, you may review 10 Short Tips for Responding to an IDFPR Investigation. You may also contact an attorney at Michael V. Favia & Associates for more information.
Michael V. Favia & Associates are available to help and meet for client consultations with offices conveniently located in the Chicago Loop, Northwest side and suburbs so you can schedule a discrete meeting with an attorney at your convenience and discretion. For more about Michael V. Favia & Associates’ professional licensing work, please visit www.IL-Licensing.com and feel free to “Like” the firm on Facebook and “Follow” the firm on Twitter.
[i] PhysiciansPractice.com, blog, Big Consequences for Doctors Importing Prescription Drugs, Feb. 6, 2013, by Ericka L. Adler.
[iii] Illinois General Assembly, Medical Practice Act of 1987, 225 ILCS 60/1 et seq.
[iv] IDFPR News Release, How the Division Responds to a Request for an Investigation of a Physician. Aug 2005.