FDA Regulatory Matters

The FDA has continued to engage in high profile investigations of physicians and pharmacies, as well as drug, device and dietary supplement manufacturers. These investigations range from sanctioning drug manufacturers hundreds of millions of dollars for failing to comply with good manufacturing practices, to investigating physicians for obtaining foreign sourced drugs and devices, to the marketing and distribution of unapproved and adulterated products.

The FDA, HHS and the Department of Justice have all demonstrated an interest in investigating and prosecuting cases where there are potential patient harm issues, and such issues almost always exist in matters involving FDA regulated products.

The attorneys at Nicholson & Eastin, LLP regularly assist clients in navigating the complex regulatory landscape of the Food, Drug and Cosmetic Act. Our attorneys have litigated a variety of civil, criminal and administrative matters involving the Food, Drug and Cosmetic Act (FDCA), as well as Customs enforcement action involving foods, drugs and medical devices. The firm’s founder is a graduate of the FDA’s law course, and has frequently lectured on FDA enforcement matters.

The FDA Office of Criminal Investigations (OCI) is the branch of the FDA that conducts investigations of suspected criminal violations of the FDCA and other related statutes. The attorneys at Nicholson & Eastin have extensive experience in dealing with OCI and its investigators, as well as the FDA’s Office of Regulatory Affairs, which is responsible for conducting regulatory inspections and audits for compliance with the FDCA and the related federal regulations.

Because of the complexity of the laws regulating the food, dietary supplement, drug and medical device industries, and the possibility of strict liability criminal exposure (no intent to violate the law needs to be proven by the government), as well as civil and administrative penalties, including fines, disgorgement of profits and disbarment, it is critically important for manufacturers, distributors, importers and exporters, and health care providers to understand the rules and laws applicable to them, and to appropriately respond to breaches of those laws. Notices of inspection (FDA 483s), and contacts by the FDA Office of Regulatory Affairs, or the Office of Criminal Investigations, should be appropriately analyzed to ensure that appropriate actions are taken to assess and respond to any deficiencies that may exist.

The attorneys at Nicholson & Eastin, LLP have represented clients in a wide array of FDA enforcement matters, and if you are currently dealing with an FDA regulatory issue or investigation, please do not hesitate to contact us for a consultation.