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DTC
FDA to Study Accelerated Approval Drug DTC Marketing
The US Food and Drug Administration (“FDA”) recently published a notice in the Federal Register seeking to find out more about how…
Drug Manufacturers File Suit to Block HHS Rule Requiring That Drug Prices…
On June 14, 2019, several pharmaceutical companies filed suit against the Department of Health and Human Services (“HHS”), seeking…
DTC Studies Shows Patients Next Step is to Research Their Own Conditions
As reported by Regulatory Focus, a new review of studies of direct-to-consumer (DTC) prescription drug advertising identifies…
HHS Finalizes Rule Requiring Manufacturers Disclose Drug Prices in TV Ads:…
On May 8, 2019, the Department of Health and Human Services (“HHS”) announced a final rule that will require direct-to-consumer…
FDA Funded Research Shows claim #1 Prescribed Has Value with Consumers
According to research funded by the FDA and published last month, participants in a study on direct-to-consumer (DTC) advertising…
PhRMA Submits Comments on CMS Proposed Regulation to Require Drug Pricing…
On December 17, 2018, the Pharmaceutical Research and Manufacturers of America (PhRMA) submitted comments in response to the…
FDA Releases Draft Guidance on DTC Advertising
In October 2018, the United States Food and Drug Administration (FDA) released a draft guidance on how to present efficacy and…
PhRMA Board Adopts Voluntary DTC Principles
On Monday, October 15, 2018, member companies of the Pharmaceutical Research and Manufacturers of America (PhRMA) announced a…
Senators Once Again Taking Up the DTC Tax Write-Off
Senator Claire McCaskill recently introduced legislation that would eliminate the ability of drug manufacturers to deduct the cost…
Drug Pricing Report Released by NASEM
The most recent example of drug marketing being caught in the crossfire of the drug pricing debate can be found in a report by the…