Tag: PhRMA

PhRMA

DTC Advertising

HHS’ Azar Announces Proposed Rule Requiring DTC Ad Price Disclosures

HHS’ Azar Announces Proposed Rule Requiring DTC Ad Price Disclosures

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 […]

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Regulatory/FDA

FDA Study of Promotion Disclosure Needs to Address First Amendment, Other Issues

FDA Study of Promotion Disclosure Needs to Address First Amendment, Other Issues

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 […]

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DTC Advertising

FDA Opens Docket on Limiting Risk Communication in DTC Ads

FDA Opens Docket on Limiting Risk Communication in DTC Ads

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 […]

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Legislative

Congress Passes FDA User Fee Legislation

Congress Passes FDA User Fee Legislation

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 […]

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DTC Advertising

PhRMA DTC Survey Shows Ads Are Valued by Consumers

PhRMA DTC Survey Shows Ads Are Valued by Consumers

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 […]

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