FDA Regulatory Issues and FDA Investigations

There is a crackdown on compounding pharmacies based on violations of sterile techniques in compounding.  The use of foreign-manufactured ingredients lacking pedigrees and lacking quality control is also a concern.  At the urging of the FDA, state legislatures and state boards of pharmacy have enacted laws and regulations to more strictly govern the compounding of medications.

The FDA is engaging in numerous high-profile investigations involving physicians and drug 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 Botox, Juviderm, Restyline, intrauterine devices (IUDs) and similar drugs and devices. These practices may also cause investigations and prosecutions for Medicaid fraud or insurance fraud.

The FDA, Department of Health and Humans Services (HHS) and the Department of Justice (DOJ) all have an interest in investigating and prosecuting cases where there are potential patient harm issues. Such issues almost always exist in matters involving FDA-regulated products.

The FDA, through its Center for Device and Radiologic Health (CDRH), also regulates medical devices such as x-ray and mammogram machines. Certification of such radiology equipment and of the facilities that use them are under the FDA. Failure to obtain and maintain certification can result in the loss of a facility’s right to perform such services.  Operating a radiology facility that is not properly certified or is improperly providing mammograms and other diagnostic services can lead to civil, administrative or criminal sanctions.  The attorneys of The Health Law Firm are experienced in representing diagnostic treatment facilities and radiology centers.  This includes responding to inspection reports, assisting in clearing noncompliance issues, defending against administrative complaints filed by the FDA CDRH, defending complaints seeking civil monetary penalties by the FDA, and other types of formal administrative hearings.

The FDA Office of Criminal Investigations (OCI) is the branch of the FDA that conducts investigations of suspected criminal violations of the Food, Drug and Cosmetic Act (FDCA) and other related statutes.  Our firm has experience in dealing with OCI and its investigators, as well as the FDA’s Office of Regulatory Affairs. This office conducts regulatory inspections and audits for compliance with the FDCA and the related federal regulations.

It is critically important for manufacturers, distributors, importers, exporters and health care providers to understand the rules and laws applicable to them and to appropriately respond to breaches. The laws regulating the industry are complex. Those in the industry can face strict liability criminal exposure, as well as civil and administrative penalties including fines, disgorgement of profits and disbarment.  Notices of inspection and contact 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 respond to any deficiencies.

The Health Law Firm provides legal advice and counseling, including preparation of documents and contracts for pharmacies, pharmacy owners, physicians and clinics.  We prep contracts and other legal documents for physicians, pharmacists and health care facilities on pharmacy issues, including structuring business ventures and compounding medications for patients. Our attorneys also represent health providers in formal and informal administrative hearings regarding disciplinary matters, rule challenges to the legal validity of new rules enacted by the state boards of pharmacy and other professional boards.  We also file Petitions for Waiver or Variance to administrative rules adopted by professional boards.

If you are currently dealing with an FDA regulatory issue or investigation, please do not hesitate to contact us for a consultation.