Tag: advertising

HHS Releases Plan to Require Drug Makers to list prices on TV ads

Yesterday, the Department of Health and Human Services (“HHS”) through the Centers for Medicare and Medicaid Services (“CMS”) released a proposed rule that would require “direct-to-consumer (DTC) television advertisements of prescription drugs and biological products for which payment is available through or under Medicare or Medicaid to include the Wholesale Acquisition […]

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 […]

West Virginia Repeals State’s Pharmaceutical Advertising Disclosure Law

The Governor of West Virginia signed last week Senate Bill 267 to repeal the Code provisions that created the Governor’s Office of Health Enhancement and Lifestyle Planning (GOHELP). This includes section 16-29H-8 of the Code, which requires prescription drug manufacturers and labelers to annually report advertising and promotion costs for the prior calendar […]

FDA Submits Notice for Collection of Information Regarding Direct-to-Consumer Advertisements

The Food and Drug Administration (FDA) recently submitted a proposed collection of information on disclosing risks in direct-to-consumer (DTC) prescription drug television (TV) advertisements to the Office of Management and Budget (OMB) for review and clearance. According to the notice published in the Federal Register on January 13, 2015, prescription […]

FDA Seeking Comments on DTC Aimed at Adolescents

On October 30, 2013, the U.S. Food and Drug Administration (FDA) announced that it is seeking public comments on research titled: “Experimental Study of Direct-to-Consumer (DTC) Promotion Directed at Adolescents.”  The pre-publication notice is available here, and final publication is expected in the October 31, 2013 Federal Register.  According to the […]

Regulator Panel at FDLI’s Advertising & Promotion Conference

The Food and Drug Law Institute (FDLI) is hosting its annual Advertising & Promotion Conference for the Pharmaceutical, Medical Device, Biologic & Veterinary Medicine Industries this week in Washington DC. The conference kicked off this morning with the highly anticipated Food and Drug Administration (FDA) regulator panel that included Thomas […]