On February 20, 2015, a 37 count indictment was unsealed by a Federal Court judge charging Med Prep Consulting, Inc. (Med Prep), a Tinton Falls, New Jersey, medical drug re-packager and processer, and its owner, Gerald Tighe, with wire fraud and various violations of the Federal Food, Drug and Cosmetic Act (FDCA). The charges relate to allegations that Med Prep adulterated and misbranded drugs, which were sold and distributed to hospitals, healthcare providers, and the general public.
According to the indictment, Med Prep represented to its customers and the United States Food and Drug Administration (FDA) that products were processed in sterile conditions. These alleged misrepresentations claimed that Med Prep adhered to and in many instances exceeded, industry standards and laws applicable to sterile drug preparation. The FDA had previously reprimanded Med Prep in 2007 over sterility issues, and the government contended that Med Prep’s continuation to represent the conditions of its facility as sterile and high quality in the fact of this “warning” constituted misrepresentation. In addition, subsequent FDA inspections revealed multiple incidents of microbiological contamination in the company’s finished drug products and triggered the recent indictment. If convicted, the individual defendants face potential imprisonment for 20 years.
This recent indictment shows an ominous trend by the Federal government and FDA regarding sterility practices by drug facilities. Failure to maintain sterility to the standards of the FDA’s preferences can now lead to criminal charges for wire fraud, and violations of the FDCA.
Specialty and compounding pharmacies need to be prepared and well-counseled for the ever-changing, heavily regulated market. Frier Levitt attorneys have spent hours reviewing the new laws and guidances, as well as communicating with the FDA. As such, Frier Levitt has unique insight into the FDA to foresee likely forms of FDA enforcement and regulations. Contact us today for assistance in preparing your pharmacy for the implementation of new requirements and adapting your business to comply with the laws and regulations going forward.