Nelson Hardiman - FDA Investigations

Nelson Hardiman advises clients on compliance with Food and Drug Administration (FDA) investigations and issues specific to healthcare providers.

Many providers are unaware of the extent to which the FDA regulates medical and healthcare practice. In recent years, the FDA has become increasingly active and, in addition to issuing warning letters threatening immediate corrective action or other regulatory enforcement, is often investigating and taking more severe enforcement actions against healthcare providers and their operations, often pressing False Claims Act charges or seeking stiff criminal sanctions for even unintentional violation of FDA laws.

The Office of Criminal Investigations (OCI) is the law enforcement arm of the FDA, and was established for the purposes of conduct and coordinating criminal investigations under the authority of the Federal Food, Drug, and Cosmetic Act (FDCA) and Federal Anti-Tampering Act (FATA). According to the FDA, OCI investigations are bad news for providers because they are not routine but rather concentrate on “significant violations of these laws, with a priority on conduct that may present a danger to the public health.” The OCI is particularly keen on investigating: (1) false statements to the FDA during the regulatory process, (2) failures of legitimate medical supply chains via unapproved, counterfeit, and substandard medical products, and (3) situations where the typical compliance and regulatory process has failed to resolve the problem and/or where there is a particularly high risk of public harm. Although the purview of the FDA is extremely broad, investigations of healthcare providers are typically focused on:

Illegal diversion of pharmaceuticals or manufacture and sale of counterfeit drugs;
Prescription Drug Marketing Act violations;
Off-Label drug and medical device promotion;
Fraudulent health treatments/cures/devices;
Fraudulent drug applications;
Fraudulent clinical investigations;
Unlawful product substitution;
Internet-enabled crimes involving FDA regulated products;
Illegal importation of regulated products; and
Illegal manufacture, sale or distribution of unapproved products.

Nelson Hardiman’s knowledge and experience with FDA regulations, regulatory compliance, and investigations is vital for providers wading into this highly-regulated space, and is particular effective when engaged early in the process. Often, investigations are initiated in response to innocent mistakes or inadvertent compliance issues by healthcare providers or their staff. Competent representation can often help resolve issues with the FDA quickly, and on reasonable terms. Nelson Hardiman’s timely involvement in these cases can be particularly instrumental, especially in those situations where a failure to convincingly respond to the FDA’s probe may be viewed as obstructive and/or lead to much more formal enforcement action, including criminal investigation and prosecution. Nelson Hardiman’s industry experience includes:

Responding to warning letters;
Defending physicians for inadvertently corrupted clinical research studies;
Defending civil and administrative investigative actions by FDA and state licensing agencies concerning alleged violations of FDA requirements for importation, purchase, and use of medications;
Counseling clients on “off label” use of drugs and devices;
Counseling clients on compliance with the federal Food, Drug, and Cosmetic Act requirements with respect to manufacturing, sale, and marketing of cosmeceutical products;
Advising Institutional Review Board (IRB) research compliance in connection with scientific research involving human research subjects and responding to research investigations;
Advising clients on Internet prescribing requirements;
Advising clients on compliance with FDA regulations specific to ESRD (dialysis centers) and responding to investigations of dialysis centers; and
Advising clients on compliance with FDA regulations specific to mammography.