Tag: FDA

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 […]

Drug Price Transparency Bill Enacted in Oregon

The Governor of Oregon signed into law this week House Bill 4005, the Prescription Drug Price Transparency Act (Act). The Act requires manufacturers to report by March 31st each year information regarding each prescription drug for which: (i) the price was $100 or more for a one-month supply or for a course of treatment […]

OIG Releases October Work Plan Items; Includes Opioid REMS and Specialty Drug Coverage and Medicare Reimbursement

As we recently announced, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The October updates include 5 new Work Plan items: Secretary Price’s Use of Chartered Aircraft for Federal Travel. OIG is reviewing Secretary Price’s use of chartered aircraft for Federal travel […]

FDA Solicits Comments Regarding Two New Studies Related to Drug Promotion

The U.S. Food and Drug Administration (FDA) published two Federal Register notices today announcing its intent to study different aspects of drug promotion. In Docket No. FDA-2017-N-1315, the FDA solicited comments regarding its planned research titled, “Experimental Study on Risk Information Amount and Location in Direct-to-Consumer Print Ads.” The FDA explained that direct-to-consumer […]

FDA Delays “Intended Use” Final Rule until March 2018

Late last week, the U.S. Food and Drug Administration (FDA) announced that it was once again delaying implementation of the final rule issued January 9, 2017 related to amendments to its regulations regarding intended use (Final Rule). This implementation delay follows a Petition to Stay and for Reconsideration (Petition) filed February 8, […]

Deadline Looms for Pharmaceutical Manufacturers and Distributors to Comply with New Expanded Access Program Reporting Requirements

Certain pharmaceutical manufacturers and distributors of an investigational drug under an investigational new drug (IND) application must make their policies for evaluating and responding to requests under an expanded access program “public and readily available” by the end of this week pursuant to section 3032 of the 21st Century Cures […]

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 […]