Tag: DTC advertising

DTC advertising

DTC Advertising

OPDP Study of Oncology DTC TV Ads Needs Tweaking, Commenters Say

OPDP Study of Oncology DTC TV Ads Needs Tweaking, Commenters Say

Dec. 9, 2019 – The Office of Prescription Drug Promotion’s (OPDP’s) proposed study of  the increasingly-common direct-to-consumer (DTC) television advertising for oncology drugs seeks to examine how consumers parse the information they are receiving, but commenters on the proposal argue that some of the study’s parameters should be changed before moving forward. The proposed OPDP […]

Read more

Courts/First Amendment

Drug Companies Forcefully Counter HHS Appeal on Mandatory Drug Prices in DTC TV Ads

Drug Companies Forcefully Counter HHS Appeal on Mandatory Drug Prices in DTC TV Ads

Nov. 18, 2019 – Amgen, Eli Lilly, Merck & Co. and the Association of National Advertisers (ANA) are once again striking back at the U.S. Department of Health and Human Services (HHS) effort to mandate drug prices in direct-to-consumer (DTC) television ads. Although the four entities sued HHS over its recent regulation calling for the […]

Read more

DTC Advertising

DTC Ad Drug Price Rule: Why Did HHS Choose the Wrong Regulations to Amend?

DTC Ad Drug Price Rule: Why Did HHS Choose the Wrong Regulations to Amend?

Oct. 21, 2019 — What is next in the effort to require inclusion of list prices in direct-to-consumer (DTC) promotion of pharmaceuticals? A variety of scenarios were outlined by James Czaban, chair of the FDA Practice Group at DLA Piper in Washington, during a panel at last week’s Food and Drug Law Institute conference on […]

Read more

DTC Advertising

OPDP DTC Research Studies Await Peer Review, Are Poised for Publication

OPDP DTC Research Studies Await Peer Review, Are Poised for Publication

Sept. 16, 2019 – Five research studies conducted by the FDA’s Office of Prescription Drug Promotion (OPDP) – four of which examine aspects of direct-to-consumer (DTC) advertising – are complete and awaiting peer review and publication, according to OPDP’s Website. “Taken together, the OPDP studies now nearing release will make an important contribution to the […]

Read more

Regulatory/FDA

OPDP Warning Letter: Omission of Risk Info in DTC Print Ad/Display Banners Misbrands ED Drug

OPDP Warning Letter: Omission of Risk Info in DTC Print Ad/Display Banners Misbrands ED Drug

Sept. 9, 2019 – In its first Warning Letter of 2019, the FDA’s Office of Prescription Drug Promotion (OPDP), continues to call out the omission of risk information cited in previous Untitled Letters this year, stating that Metuchen Pharmaceuticals LLC’s direct-to-consumer (DTC) print ad and display banners for its erectile dysfunction (ED) drug include claims […]

Read more

Courts/First Amendment

Court Rules Mandatory Drug Price Disclosure Rule Invalid, Stating CMS Lacks Statutory Authority

Court Rules Mandatory Drug Price Disclosure Rule Invalid, Stating CMS Lacks Statutory Authority

July 9, 2019 – One day before the Centers for Medicare & Medicaid Services’ (CMS’) final rule requiring drug companies to disclose the wholesale acquisition cost (WAC) or “list price” of their drugs in television ads was due to go into effect, the U.S. District Court for the District of Columbia issued a memorandum opinion […]

Read more

CHC News

Sharon Callahan: The Coalition Is “Our Voice in Washington”

Sharon Callahan: The Coalition Is “Our Voice in Washington”

May 16, 2019 – In a May 15 podcast interview with Medical Marketing & Media’s (MM&M’s) Senior Editor Larry Dobrow, Sharon Callahan, CEO, TBWA\WorldHealth; chief client officer, Omnicom Health Group, spoke about her many years as a member and the former chair – and first woman chair – of the Coalition for Healthcare Communication’s executive […]

Read more

DTC Advertising

CMS Final Rule Requiring List Prices in DTC TV Ads Virtually the Same as Original Proposal

CMS Final Rule Requiring List Prices in DTC TV Ads Virtually the Same as Original Proposal

May 9, 2019 — The Centers for Medicare & Medicaid Services (CMS) has announced its final rule requiring that drug companies include list prices in direct-to-consumer (DTC) television ads – “the single most significant step any administration has taken toward a simple commitment: American patients deserve to know about the prices of the healthcare they […]

Read more

CHC News

FDA After Gottlieb: Nancy Myers Added to Rising Leaders Conference on Healthcare Policy

FDA After Gottlieb: Nancy Myers Added to Rising Leaders Conference on Healthcare Policy

April 23, 2019 — Will new FDA leadership drive to continue Dr. Gottlieb’s initiatives? Will they have the clout within the FDA, HHS, and Congress to do so? How will this affect health marketing and communications? Nancy Bradish Myers, president of Catalyst Healthcare Consulting and former president of the Alliance for a Stronger FDA, will […]

Read more

DTC Advertising

Despite Industry’s Price Transparency Initiatives, CMS Pushes Proposed Rule Forward

Despite Industry’s Price Transparency Initiatives, CMS Pushes Proposed Rule Forward

April 8, 2019 – The first television ads including drug price information are hitting the airwaves, reinforcing the point that list price is a highly misleading metric, and Pharmaceutical Research and Manufacturers of America (PhRMA) members are preparing to voluntarily refer consumers to online drug pricing information in their drug ads within a few weeks. […]

Read more