By: Christopher A. Parrella, Esq., CPC, CHC, CPCO
Parrella Health Law, Boston, Ma.
A Health Care Defense and Compliance Firm


In a recent verdict that underscores the critical importance of adherence to FDA regulations and the dire consequences of circumventing these standards, a Lexington, Massachusetts psychiatrist was found guilty of engaging in an international money laundering scheme, importing illegal merchandise, and the receipt and delivery of a misbranded drug. This conviction follows a 14-day jury trial, spotlighting the rigorous enforcement of healthcare compliance and regulatory laws by the U.S. Attorney’s Office for the District of Massachusetts.

Dr. Rahim Shafa, aged 66, was convicted on charges that bring to light the severe legal repercussions for healthcare professionals who bypass the established drug approval process. According to the U.S. Attorney’s Office, Dr. Shafa engaged in these illicit activities for approximately a decade, demonstrating a blatant disregard for the healthcare system’s regulatory framework designed to safeguard public health and safety. The sentencing, set for May 15, 2024, could result in significant prison time and fines, reflecting the gravity of such offenses.

Dr. Shafa’s operation involved the purchase and importation of naltrexone and disulfiram pellet implants and injections from Hong Kong, forms of the drugs that are not approved by the FDA for use in the United States. By falsifying shipping documents, Dr. Shafa concealed the true nature of these shipments, misleading authorities and endangering patients’ health who underwent implantation procedures without a full understanding of the potential risks.

This case highlights several critical points for healthcare providers and professionals navigating the complexities of FDA regulations and compliance:

The Imperative of Compliance: Adherence to FDA approval processes is not merely a legal requirement but a fundamental responsibility to ensure patient safety and effective treatment.

Legal Ramifications: The significant legal consequences faced by Dr. Shafa serve as a potent reminder of the potential criminal, civil, and administrative penalties for non-compliance with healthcare laws and regulations.

Interagency Collaboration: The case exemplifies the collaborative efforts of various federal agencies, including the FDA’s Office of Criminal Investigations and the U.S. Department of Health and Human Services’ Office of Inspector General, underscoring the government’s commitment to enforcing healthcare regulations.

For healthcare professionals and organizations, this case underscores the necessity of rigorous compliance programs and the importance of understanding the legal and regulatory landscape. Non-compliance exposes providers to substantial legal risks and penalties.