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DTC
FDA Issues Enforcement Letter Regarding Eskata Risks Omitted From DTC…
The US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) recently issued an enforcement letter…
FDA Issues Advertising Warning Letter to Vivus
The FDA’s Office of Prescription Drug Promotion (OPDP) issued its second untitled letter of the year to California drugmaker Vivus…
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FDA Releases Draft Guidance on DTC Advertising
In October 2018, the United States Food and Drug Administration (FDA) released a draft guidance on how to present efficacy and…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…