DEA and FDA Investigations

DEA Regulatory Matters

The attorneys at Nicholson & Eastin, LLP regularly assist physicians, pharmacists and health care facilities with compliance reviews, administrative audits and investigations relating to the federal and state laws regulating the storage, prescribing and dispensing of controlled substances.

According to the DEA, combating the diversion of controlled substances is a top priority of the agency. Consistent with this statement, DEA has significantly stepped up its enforcement efforts against controlled substance distributors, prescribers and pharmacies, bringing administrative, civil and criminal actions against registrants. These actions can include the denial of a registration application, the revocation of a registration, civil penalties and criminal prosecution…[READ MORE]

FDA Regulatory Matters

The FDA continues to engage in high profile investigations involving physicians and pharmacies, as well as drug, device and dietary supplement manufacturers. These investigations range from sanctioning drug and device 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 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…[READ MORE]