Pharmacy Law

/Pharmacy Law

Drug Diversion Scheme Earns Houston Man 15-Year Stint in Federal Prison

On July 17, 2018, the former president of Cumberland Distribution, Inc. (Cumberland) was sentenced to 15 years in prison and ordered to forfeit $1.4 million for his leading role in a drug diversion plot in which tainted pharmaceuticals were shipped to pharmacies nationwide from a Nashville warehouse. Jerrod Nichols Smith and his co-conspirators, Charles Jeffrey [...]

DOJ Announces Revised Opioid Anti-Diversion Policy

Last week, the Department of Justice (DOJ) announced that it had finalized new rules to prevent the diversion of prescription opioids in a move designed to curb the national opioid crisis.  The rules, initially proposed in April 2018, received over 1600 comments during a 30-day comment period. A DOJ summary of the new rules notes that the [...]

GAO Issues Report Critical of 340B Contract Pharmacy Oversight

Late last month the Government Accountability Office (GAO) released a report entitled, “Drug Discount Program: Federal Oversight of Compliance at 340B Contract Pharmacies Needs Improvement”. The 60-page Report details a number of weaknesses in the 340B Drug Pricing Program, particularly as it regards the oversight of contract pharmacies by the Department of Health and Human [...]

Client Alert – “Takedown Day”: Feds Announce Largest Health Care Fraud Enforcement Action in Department of Justice History

On June 28, 2018, Attorney General Jeff Sessions, together with Department of Health and Human Services (HHS) Secretary Alex M. Azar III and representatives of the FBI, DEA, and several other federal departments and agencies, announced the largest ever health care fraud enforcement action. A total of 601 individuals are charged with various health care [...]

Client Alert – FDA Gives Go-Ahead to First Marijuana Derived Drug

Earlier this week the U.S. Food and Drug Administration (FDA) approved for use Epidiolex (cannabidiol) [CBD], an oral solution containing CBD, a chemical component of the Cannabis sativa plant that does not cause the intoxication or euphoria that is produced by THC, the primary psychoactive component of marijuana. Epidiolex is the first FDA-approved drug that [...]

FDA Releases Final Guidance on Drug and Medical Product Communications with Payors and Others

Earlier this week, the U.S. Food and Drug Administration (FDA) issued two new final guidance documents that provide greater clarity regarding the FDA’s position and recommendations on drug and medical product communications with payors, formulary committees and others. In a statement, FDA Commissioner Scott Gottlieb indicated that the guidance documents are a response to the [...]

New Court Ruling Limits Federal Trade Commission Reach in Data Security Enforcement

Yesterday the 11th U.S. Circuit Court of Appeals in Atlanta vacated a Federal Trade Commission (FTC) cease and desist order directing a medical testing company to overhaul its data security program on the grounds that the order was overbroad and failed to enjoin any specific act or practice. This ruling means that going forward (at [...]

Humana Files “Reverse FOIA” Action against Defense Health Agency

In an unusual action, health insurance giant Humana’s government arm, Humana Government Business (also known as Humana Military), has filed suit against the agency responsible for the operation of Tricare in an attempt to protect what the company deems proprietary and trade secret information. The suit, dubbed a “reverse freedom of information act” (FOIA) suit, [...]

Pfizer Runs Afoul of Feds with Patient Assistance Program Payments

The U.S. Department of Justice announced late last week that it had settled with Pfizer, Inc.  (Pfizer) over allegations that the company had constructed a scheme, in conjunction with a third-party pharmacy and the not-for-profit Patient Assistance Network, to provide kickbacks to Medicare patients who took certain medications manufactured by Pfizer. The $23.8 million settlement [...]

DOJ Reasserts Focus on Antitrust Enforcement in Healthcare

During his keynote speech at last week’s American Bar Association 2018 Antitrust in Healthcare Conference, Deputy Assistant Attorney General Barry Nigro reaffirmed the Justice Department’s commitment to continued antitrust enforcement across the healthcare industry, promising rigorous prosecution of price gouging and fraud, in addition to protecting competition in the healthcare marketplace. Nigro’s address was wide-ranging, [...]