Pharmacy Law

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Client Alert – Guilty Pleas Continue to Amass in New Jersey State Health Benefits Fraud Investigation

October 12, 2017 - In late summer we issued a client alert describing a healthcare fraud scheme that had hit two New Jersey state health benefits programs for over $25 million by submitting fraudulent prescriptions for compounded medications. At the time of the initial alert, five conspirators had submitted guilty pleas to an assortment of [...]

Client Alert – Insys Therapeutics Runs Afoul of Attorneys General in Two States

October 10, 2017 - Arizona-based pharmaceutical company Insys Therapeutics Inc. (Insys) has found itself under investigation in both Massachusetts and New Jersey over the aggressive marketing of its opioid-fentanyl drug Subsys. Subsys has been approved by the FDA for use with breakthrough pain in cancer patients who have developed tolerance to other opioid-based drugs. The [...]

Client Alert – Diagnostic Test Maker Alere Faces Whistleblower FCA Suit

October 9, 2017 - A recently unsealed suit against Alere Inc., initially filed by two whistleblowers in a Florida federal court in 2015, reveals multiple allegations of False Claims Act (FCA) and Anti-Kickback Statute violations against the diagnostic test-maker. The whistleblowers, former Alere vice president of business development Michael Nolan and Jacob Whitfield, a former [...]

Client Alert – PBMs are Targets in Nevada’s Diabetes Drug-Pricing Transparency Bill

July 31, 2017 - In the absence of federal action, Nevada, along with a number of other states, is enacting legislation to combat skyrocketing drug prices and create transparency regarding the pricing activities of drug manufacturers and Pharmacy Benefit Managers (PBMs). Nevada’s Senate Bill 539 places new reporting requirements on pharmaceutical manufacturers and PBMs for [...]

Oregon Adds Teeth to PBM Oversight

Add Oregon to the list of states that have enacted laws during their 2017 legislative sessions that codify further oversight over Pharmacy Benefit Managers (PBMs) and their business practices. Oregon initially passed legislation in 2013 that required PBMs to register with the Oregon Department of Consumer Services (DCBS). The registration requirements and fee were minimal, [...]

Client Alert: Another State Takes Action Against PBMs

July 24, 2017 - State legislatures across the country have begun to tackle the issues created for both consumers and pharmacists alike by Pharmacy Benefit Managers (PBMs) and their business practices. In a previous alert we mentioned Public Act 17-241, a bill recently signed into law in Connecticut that addressed “secret price gouging” by PBMs. [...]

Connecticut Takes Steps to Curb Price Gouging by PBMs

July 14, 2017 - Connecticut Governor Dannel Malloy has just signed into law Public Act 17-241, a bill that forbids certain contract provisions between Pharmacy Benefit Managers (PBMs) and pharmacies that limit price information that can be provided to consumers. The Act is designed to curtail what legislators termed “secret price gouging” by PBMs. PBMs, [...]

Pharmacist at Center of 2012 Fungal Meningitis Outbreak Sentenced to 9 Years in Prison

Earlier this year a federal court jury in Boston found the owner of a now-defunct compounding pharmacy guilty of racketeering and fraud for his role in a meningitis outbreak that sickened hundreds and led to the deaths of 76 people. On June 27, Barry Cadden, the owner and head pharmacist at the New England Compounding [...]

Client Alert – Members of Congress Call for Review of FDA Guidance on Compounding under Section 503A

June 27, 2017 - Earlier this year, we focused one of our client alerts on a new Guidance issued by the Food and Drug Administration (FDA) concerning certain prescription requirements for compounding human drug products under section 503A of the Federal Food, Drug, and Cosmetic Act. See "FDA Issues Guidance on Prescription Requirement for Compounded [...]

Georgia Pharmacy Agrees to Settle False Claims Act Allegations for $2 Million

The Rhine Drug Company (Rhine) and its owner Carter Clements agreed last week to a settlement with the U.S. Attorney’s Office for the Southern District of Georgia to resolve allegations of violating the False Claims Act and Controlled Substance Act. Rhine and Clements will pay $2.175 million, making it the largest False Claims Act recovery [...]