By: Christopher A. Parrella, Esq., CPC, CHC, CPCO
Parrella Health Law, Boston, Ma.

As healthcare defense and compliance professionals, we at Parrella Health Law are keenly aware of the importance of maintaining high standards in pharmaceutical manufacturing and distribution. The recent case involving Massachusetts-based Pharmasol Corporation serves as a poignant reminder of these standards.

On December 14, 2023, a federal court took decisive action against Pharmasol Corporation and its president, Marc L. Badia, by issuing an injunction to halt the manufacturing and distribution of adulterated drugs. This move underscores the critical role of regulatory compliance in the pharmaceutical industry and the serious consequences of non-compliance.

Pharmasol, known for manufacturing both prescription and over-the-counter drugs, including Lexette and Dexamethasone, faced allegations of violating the Federal Food, Drug and Cosmetic Act (FDCA). The complaint, filed by the United States, highlighted the company’s failure in several critical areas: notifying customers about product defects, establishing a proper complaint procedure, and maintaining equipment to the necessary standards.

Notably, the United States cited 533 customer complaints within a 12-month period, indicating systemic issues at Pharmasol’s South Easton facility. Repeated violations were identified by the Food and Drug Administration (FDA) over several years, including similar infractions noted in inspections conducted in 2018, 2021, and 2022.

The importance of adhering to current good manufacturing practice (cGMP) regulations cannot be overstated. These regulations are designed to ensure that drugs are produced with the necessary identity, strength, quality, and purity for safe and effective use. The Pharmasol case is a glaring example of how deviation from these practices results in adulterated products that pose significant risks to public health.

The Justice Department, with its firm commitment to enforcing compliance, worked closely with the FDA to address these violations. As Principal Deputy Assistant Attorney General Brian M. Boynton emphasized, drug manufacturers bear a critical responsibility to comply with regulations ensuring drug quality and safety.

The repercussions for Pharmasol are severe. Apart from the injunction, the company and its president agreed to a consent decree of permanent injunction. This decree mandates the cessation of manufacturing, processing, and distribution of adulterated drugs, along with the recall of all adulterated prescription drugs distributed since February 10, 2022.

This case serves as a stark reminder to all in the pharmaceutical industry of the paramount importance of regulatory compliance. At Parrella Health Law, we understand that maintaining these standards is not just a legal requirement but a moral imperative to protect the health and safety of the public. As legal professionals specializing in healthcare defense and compliance, we are committed to guiding and supporting our clients through the complexities of regulatory compliance, ensuring the highest standards are met for the benefit of all.

The Pharmasol case is a lesson and a warning: compliance is not optional, and the consequences of non-compliance are far-reaching, impacting not just the companies involved but, more importantly, the health and safety of consumers.

Christopher Parrella, ESQ, CPC, CHC, CPCO, is the founding partner of Parrella Health Law in Boston, Mass. The firm focuses exclusively on healthcare defense and compliance matters. Chris also travels the country on behalf of a wide range of healthcare organizations, lecturing on a variety of health care enforcement and compliance topics. Chris is one of a handful of health care attorney’s that are also Certified Professional Coders (CPC) and is a member of the AAPC’s National Legal Advisory Board and Ethics Committee.  He is also a Certified Professional Compliance Officer (CPCO) and Certified in Health Care Compliance (CHC.)Christopher Parrella, ESQ, CPC, CHC, CPCO, is the founding partner of Parrella Health Law in Boston, Mass. The firm focuses exclusively on healthcare defense and compliance matters. Chris also travels the country on behalf of a wide range of healthcare organizations, lecturing on a variety of health care enforcement and compliance topics. Chris is one of a handful of health care attorney’s that are also Certified Professional Coders (CPC) and is a member of the AAPC’s National Legal Advisory Board and Ethics Committee.  He is also a Certified Professional Compliance Officer (CPCO) and Certified in Health Care Compliance (CHC.)