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Manufacturer ALERT: DEA Announces Proposed Regulations to Combat Opioid Crisis

In an effort to address the national opioid crisis, the Drug Enforcement Administration (DEA) recently announced proposed regulations to improve oversight of the production of dangerous drugs that might be vulnerable to diversion.  The DEA's proposal amends the manner in which the DEA grants quotas to manufacturers for maintaining inventories and introduces several new types of quotas that DEA would grant to certain DEA-registered manufacturers. The proposed regulations incorporate important...

Pharmacy ALERT: Pharmacies Receive Subpoenas Regarding RDC Contracts

State and local governments across the country have taken the opioid crisis head-on, many of them filing civil lawsuits against opioid manufacturers, wholesalers, distributors and healthcare providers. As part of these lawsuits, plaintiffs have been issuing subpoenas to pharmacies that purchased products, including opioids, from wholesalers and distributors, such as Rochester Drug Co-Operative, Inc. (RDC). The subpoenas request numerous documents and often require a significant amount of time and resources...

Manufacturer ALERT: False Claims Act Violation for Selling Unapproved Medical Devices

On September 13, 2019, Manhattan U.S. Attorney for the Southern District of New York announced that the Government has simultaneously filed and settled a civil fraud lawsuit under the False Claims Act against Avalign Technologies, Inc. (Avalign) and its subsidiary, Instrumed International, Inc. (Instrumed), for manufacturing and selling medical devices that were not cleared by the U.S. Food and Drug Administration (FDA.) As part of the settlement, Avalign and Instrumed...

The Importance of Having Competent Legal Counsel for State Board of Pharmacy Matters

State boards of pharmacy throughout the country serve important functions including overseeing the licensing and registration of pharmacies, pharmacists, and pharmacy technicians; establishing and enforcing the laws and regulations governing the practice of pharmacy; and overseeing disciplinary proceedings involving pharmacies and pharmacists. While the need for competent legal counsel in formal proceedings, such as a hearing or trial, is well known, several states throughout the country conduct more "informal" disciplinary...

Plan Sponsor ALERT: PBMs “Double-Dipping” on Audit Fees from Pharmacies and Plan Sponsors

Millions of Americans across the country are employed by public-sector entities and other self-funded employers, insurers, and managed healthcare organizations (collectively "Plan Sponsors"), who often turn to Pharmacy Benefit Managers (PBMs) for the administration and management of pharmacy benefits. PBMs are tasked, among other things, with maintaining a network of pharmacies and monitoring the pharmacies' claims through various mechanisms, ranging from routine pharmacy audits to Fraud, Waste, and Abuse (FWA)...