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 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
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
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
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
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
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 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 Feb. 11, 2019 – Last week Johnson & Johnson announced that it would include both the list price of a drug and information about what patients realistically might expect to pay out of pocket for its drugs in direct-to-consumer (DTC) ads by the end of the first quarter, starting with Xarelto, its most-prescribed medication. This […]
Read more
Feb. 5, 2019 – Patient and disease advocacy groups have weighed in on the Centers for Medicare & Medicaid Services (CMS) proposal to require that drug companies list the wholesale acquisition cost (WAC) for their drugs in televised direct-to-consumer (DTC) ads. Their comments to CMS raise issues about whether the proposed rule asks for disclosure […]
Read more