Pharmacy Law

/Pharmacy Law

Client Alert – Justice Department Reports FCA Recoveries for FY2019

Last week the U.S. Department of Justice issued a compilation of False Claims Act recovery information showing that it had obtained more than $3 billion in settlements and judgments during the course of fiscal year 2019 (October 2, 2018 – September 20, 2019). The bulk of recoveries once again arose in the health care industry—a [...]

New Legal Exposures Appearing for Makers and Sellers of CBD Products

Earlier this fall, we released a client alert regarding FTC warning letters issued to various companies warning that their advertising of CBD oils, tinctures, capsules, “gummies” and creams may violate FTC rules. Similarly, the FDA issued warning letters this year to a number of firms marketing CBD products, citing them for misbranded drug products, unsubstantiated [...]

Client Alert – FDA Issues More Warning Letters Regarding the Marketing of Cannabidiol-Containing Product

Yesterday the FTC issued letters to three unidentified companies warning that their advertising of CBD oils, tinctures, capsules, “gummies” and creams may violate FTC rules. The Commission issued similar letters in April to Nutra Pure, PotNetwork Hold and Advanced Pain. The companies are being warned regarding unsubstantiated claims related to a number of different cannabidiol [...]

Health Care Continues to Predominate in False Claims Act Settlements with DOJ

Having passed the halfway point of 2019, recent reporting on Department of Justice (DOJ) settlement amounts under the False Claims Act (FCA) points to a slight increase from the same period in 2018. Thus far, DOJ has accounted for over $750 million in FCA settlements—predominantly from health care and pharmaceutical entities. Also, as in past [...]

Client Alert – White House Withdraws Proposed Rebate Rule

Late last week the White House announced that the administration would no longer move forward with its proposed rule that would have ended pharmaceutical rebate safe-harbors for pharmacy benefit managers. We initially addressed the proposed rule in our alert, “The End of the PBM Rebate Safe Harbor? The Stakeholders React.” “Based on careful analysis and [...]

Client Alert – Florida Court Holds the State’s Medical Marijuana Statute Unconstitutional

In a decision that hinged on the use of “and” instead of “or,” Florida’s 1st District Court of Appeals struck down the State’s medical marijuana law, finding that its “vertical integration” scheme fails to comport with the language and intent of the constitutional amendment that initially legalized medical marijuana in 2016. The amendment, approved by [...]

Client Alert – Reverse Pharmaceutical Distributor and Execs Hit with Heavy Penalties for Fraudulent Scheme

A Long Island-based reverse pharmaceutical company, along with two of its top executives, were hit with large fines and ordered to pay some $94 million in restitution by a federal judge following their convictions on a number of charges, including mail fraud, wire fraud, theft of government property, money laundering conspiracy, obstruction of justice, and [...]

Client Alert – FDA Takes First Look at Issues Involved in CBD Regulation

Last week the U.S. Food and Drug Administration (FDA) held a 9-hour public hearing on the issues surrounding its potential regulation of hemp-derived cannabidiol, more commonly referred to as CBD. The panel heard from over 100 speakers, running the gamut from academics, cannabis trade associations and manufacturers, to state officials, members of the agricultural community, [...]

Client Alert – The First, But Maybe Not The Last? Feds Convict Insys Execs in Opioid Racketeering Case

In a first of its kind prosecution, the US Department of Justice has successfully tried and convicted several top pharmaceutical executives for crimes related to the marketing and sale of opioids. The founder of Insys Therapeutics Inc. (Insys), John N. Kapoor, and four other former Insys executives were convicted in Massachusetts of a RICO conspiracy [...]

Client Alert – DOJ Criminal Division Releases Guidance on Evaluation of Corporate Compliance Programs

The Criminal Division of the United States Justice Department (DOJ) recently released a guidance document for its prosecutors as an adjunct to the agency’s Justice Manual. The Manual provides direction to prosecutors on the factors they should consider when conducting an investigation into alleged corporate wrongdoing. The adequacy and effectiveness of a corporation’s compliance program [...]