Jan. 15, 2019 – In comments to the Centers for Medicare and Medicaid Services (CMS) regarding its proposal to require that drug companies include the wholesale acquisition cost (WAC) of a drug in direct-to-consumer (DTC) television ads, industry trade groups and pharmaceutical companies largely are in agreement that doing so would confuse consumers, that CMS […]
Read more
Dec. 10, 2018 – The Health and Human Services (HHS) proposal to require that drug companies include drug list prices in direct-to-consumer (DTC) ads could potentially confuse patients, and it also could cause patients to defer treatment because of the misleading price tag, according to Robert Zirkelbach, EVP of public affairs, Pharmaceutical Research and Manufacturers […]
Read more
Oct. 16, 2018 – Yesterday morning, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced a program under which member companies would refer patients to online information about medicine costs in direct-to-consumer (DTC) ads. But then yesterday afternoon, Department of Health and Human Services (HHS) Secretary Alex Azar made clear that this effort would not […]
Read more
Sept. 5, 2017 – An FDA-proposed study to determine whether healthcare professionals (HCPs) and consumers can utilize disclosures to correctly frame efficacy claims in prescription drug promotion raises First Amendment concerns about communication and requires fixes to the study construct, according to August comments on the June 14 proposal. “Disclosure is an important topic that […]
Read more
Aug. 22, 2017 – In the wake of an FDA study showing that consumers recall risk information better when they are not inundated with a comprehensive list of risks in direct-to-consumer (DTC) ads, the agency is establishing a public docket “to assist with its development of recommendations” in this area. The FDA’s Office of Prescription […]
Read more
Aug. 7, 2017 – In a 94-1 vote, the U.S. Senate on Aug. 3 passed FDA user fee reauthorization legislation that will revise and extend the user fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products through 2022. H.R. 2430, the FDA Reauthorization Act of 2017, was passed by the House […]
Read more July 25, 2017 – A large majority of Americans recognize the value of the information provided in direct-to-consumer (DTC) ads and state that the ads promote adherence and help patients remember to visit their doctor, according to a recent survey of 1,500 people sponsored by the Pharmaceutical Research and Manufacturers of America (PhRMA) and conducted […]
Read more