Enacted on December 29, 2022, the Modernization of Cosmetics Regulation Act ("MoCRA") applies more of a drug-like regulatory framework to cosmetics. The landmark legislation significantly overhauls the Food and Drug Administration’s (“FDA”)... Read More
Frier Levitt attorneys speak with prosecutors, Boards of Pharmacies, PBM auditors, wholesalers, and the like on a daily basis on behalf of pharmacies nationally. We regularly spot trends and report back to the industry. We are closely monitoring... Read More
The Federal Trade Commission (“FTC”) recently enforced its Health Breach Notification Rule (“Rule”) for the very first time. The FTC issued a $1.5 million civil penalty to GoodRx and imposed restrictions on the company’s future handling of... Read More
As the cost of health care continues to rise, the presence and use of prescription discount cards has increased as well. Prescription discount cards – such as GoodRx or SingleCare – purport to offer patients access to various forms of discounts... Read More
Recently, on July 21, 2021, the U.S. Food and Drug Administration (“Agency” or “FDA”) denied a new dietary ingredient (“NDI”) notification filed by Charlotte’s Web for full spectrum hemp extract containing cannabidiol (“CBD”). ... Read More
Recently, three operators of a Wisconsin CBD dispensary were arrested and are awaiting felony drug charges after failing to comply with the state law. The investigation into the dispensary began when two minors consumed a CBD-related products... Read More
On February 4, 2021, the Attorneys General of 47 states announced a $573 million joint settlement with the global consulting firm McKinsey & Company. The settlement, in which McKinsey did not admit wrongdoing, was predicated on McKinsey’s... Read More
Last week, the U.S. Court of Appeals for Second Circuit ruled that the Food and Drug Administration (FDA) cannot prosecute pharmaceutical manufacturers’ representatives for speech promoting the lawful, off-label use of an FDA-approved drug. The... Read More
One of the fastest growing and hottest topics among compounding pharmacies is the marketing of compounded pharmaceuticals by pharmacies to physician groups. More compound pharmacies are marketing directly to area physicians, but our experience shows... Read More