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 Aug. 26, 2019 — The Department of Health and Human Services (HHS) last week filed a notice in the U.S. District Court for the District of Columbia stating that it would appeal the July 8 decision of U.S. District Court Judge Amit P. Mehta that declared invalid and set aside the Centers for Medicare & […]
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 June 17, 2019 – The Trump administration’s final rule mandating that drug companies include the wholesale acquisition cost (WAC) in direct-to-consumer (DTC) television ads for many drugs “exceeds [the Department of Health and Human Services’ (HHS’)] statutory authority, violates the First Amendment, and should therefore be set aside,” according to a lawsuit filed Friday, less […]
Read more
Jan. 20, 2017 – The FDA effectively delayed any prompt action on new guidance covering the promotion of unapproved or off-label uses yesterday by extending the comment period related to the November 2016 hearing on this topic from Jan. 9 to April 19, and by issuing a 60-plus page memorandum that outlines the agency’s position […]
Read more May 31, 2016 – Although the U.S. Supreme Court and other courts consistently are deciding cases in favor of First Amendment protections for commercial speech – including speech about off-label uses – the movement toward a “truthful and non-misleading” standard has not moved the needle on this issue at the FDA, according to Alan Bennett, […]
Read moreMay 9, 2016 – In an April 29 comment to the FDA on its recent proposal to conduct research on how animation in direct-to-consumer (DTC) prescription drug advertising affects viewer comprehension, The Advertising Coalition (TAC) asks the agency to consider the Office of Prescription Drug Promotion’s mission statement “in the context of a series of […]
Read moreApril 25, 2016 — In a speech at the Alliance for a Stronger FDA’s quarterly meeting April 19, new Commissioner of Food and Drugs Dr. Robert M. Califf stated that the agency’s current priorities include determining when advertising is false or misleading and addressing labeling and patient/consumer communication, among others. He also indicated that the […]
Read moreMarch 3, 2016 – As the FDA fails to update or further clarify its policy regarding off-label promotion, the courts continue to hear cases that are being decided in favor of allowing.S. District Judge Royce Lamberth has entered an order dismissing the case; it is not subject to appeal. companies to share truthful and non-misleading […]
Read moreFeb. 2, 2016 – The FDA’s recent announcement regarding which new and revised guidance documents it plans to publish in 2016 includes four long-awaited guidance documents by the Office of Prescription Drug Promotion (OPDP). “While the agency has been pondering its options, consumers and health professionals are expecting the industry to move forward and participate […]
Read more