Tag: drug

Nevada DHHS Releases 2019 Drug Transparency Report

The Nevada Department of Health and Human Services (DHHS) released today its 2019 Drug Transparency Report in connection with the state law requiring transparency related to essential diabetes drugs (EDD). Notably, the Report states that 695 drug national drug codes (NDCs) were included on the February 2019 EDD list published […]

FDA Releases Draft Guidance Regarding Indications and Usage Section of Drug Labeling

The U.S. Food and Drug Administration (FDA) announced today the availability of a new draft guidance titled, “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.” This draft guidance provides insight into the FDA’s current thinking related to the INDICATIONS AND USAGE section […]

Two Enacted State Laws Permit Truthful Off-Label Promotion

Earlier this month, Tennessee House Bill 2220 (substituted for Senate Bill 2361) (Tennessee Law) was enacted, which provides, “A pharmaceutical manufacturer or its representatives may engage in the truthful promotion of off-label uses.” The Tennessee Law is effective July 1, 2018. This law follows on the heels of “The Free […]

FDA Announces Critical Off-Label Forum for Drugs and Devices

A notice was published today in the Federal Register regarding a two day public hearing that will be held on November 9-10, 2016 by the U.S. Food and Drug Administration (FDA) to obtain input from a wide range of stakeholders regarding communications by industry related to unapproved uses of FDA-regulated drugs, biological […]

HHS OIG Approves Drug Company Program Providing Free Cancer Treatment Drugs

On Tuesday, the Health and Human Services (HHS) Office of Inspector General (OIG) issued an Advisory Opinion regarding a program to provide a 30-day supply of cancer drugs free of costs to patients who experience an insurance coverage determination delay of at least five business days (the Free Supply Program).  The […]

Kim Kardashian Drug Endorsement Results in FDA Warning Letter

The U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued a Warning Letter this week to Duchesnay, Inc. related to celebrity Kim Kardashian’s social media posts on Instagram, Twitter and Facebook regarding the company’s drug, DICLEGIS. In the posts, Kardashian states that she is “partnering with Duchesnay […]