Tag: FDA Draft Guidance

FDA Draft Guidance

DTC Advertising

OPDP Guidance on Presenting Risk, Efficacy Info in DTC Ads Calls for Consumer-friendly Approaches

OPDP Guidance on Presenting Risk, Efficacy Info in DTC Ads Calls for Consumer-friendly Approaches

Oct. 19, 2018 – It is important for drug companies to make quantitative presentations of risk or efficacy information in direct-to-consumer (DTC) ads more consumer friendly, according to draft guidance issued by the FDA’s Office of Prescription Drug Promotion (OPDP). The draft guidance, “Presenting Quantitative Efficacy and Risk Information in [DTC] Promotional Labeling and Advertisements,” […]

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Regulatory/FDA

OPDP Plans Just One Guidance Document for 2017

OPDP Plans Just One Guidance Document for 2017

Feb. 20, 2017 – Although the FDA announced last August that it would issue four advertising-related guidance documents by the end of 2016, the Office of Prescription Drug Promotion (OPDP) fell short of that goal and apparently will set a very low bar for 2017: It plans to issue only one guidance document in 2017. […]

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Jury Says “Not Guilty” to Off-label Charges in Medical Device Case

March 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 […]

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FDA Draft Guidance Describes Framework for Electronic Submission of Promotional Materials

April 22, 2015 – Healthcare marketers soon will have to submit promotional labeling and advertising materials to the FDA electronically, according to a draft guidance document announced by the FDA in today’s Federal Register. That document, “Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs,” explains […]

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New FDA Social Media Guidances Address Space-limited Media, Correcting Online Misinformation

June 23, 2014 – Although the two social media draft guidance documents the FDA’s Office of Prescription Drug Promotion (OPDP) issued June 17 do not exactly establish any new marketing policy, they do help industry to understand what is expected by the agency in several online forums, according to Coalition for Healthcare Communication Executive Director […]

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FDA Denies Citizen Petition to Increase DTC Ad Font Size

June 28, 2013 – The Food and Drug Administration (FDA) recently denied a 2009 petition from the Pharmacists Planning Service Inc. (PPSI) requesting that the FDA “standardize and increase print size for direct-to-consumer [DTC] advertising for readability of patients and consumers,” particularly the elderly. In a June 10 letter to the petitioner, Center for Drug […]

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PhRMA, Industry Members Object to TV Ad Review Draft Guidance

June 4, 2012 – In recent comments to the FDA regarding a draft guidance that would call for prior review of six categories of direct-to-consumer (DTC) television ads, the Pharmaceutical Research and Manufacturers of America (PhRMA) stated that it is “concerned” that the FDA’s proposal infringes on the drug industry’s First Amendment rights. Coalition for Healthcare […]

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Pew Survey Confirms Importance of Internet to Consumers

March 4, 2011 — Although the medicines industry is treading carefully in its use of Internet marketing, new research confirms that consumer use of the Internet is growing. Consumers both use and value the ability to research health topics online, according to the recently released results of a Pew Internet Project/California HealthCare Foundation survey. Meanwhile, pharmaceutical companies […]

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