May 9, 2022 – New analyses of clinical trials conducted in the United States and in Europe on potential new drugs found that not only were study populations not as diverse as the general population, but that frequently no race or ethnicity data was included in the trial reports, and sometimes not even gender data. […]
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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presentations of risk or efficacy information in direct-to-consumer (DTC) ads more consumer friendly, according to draft guidance issued by the FDA’s Office of Prescription Drug Promotion (OPDP). The draft guidance, “Presenting Quantitative Efficacy and Risk Information in [DTC] Promotional Labeling and Advertisements,” […]
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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. […]
Read moreMarch 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 […]
Read moreApril 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soon will have to submit promotional labeling and advertising materials to the FDA electronically, according to a draft guidance document announced by the FDA in today’s Federal Register.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 […]
Read moreSept. 30, 2014 – Companies striving to use social media marketing both effectively and appropriately likely will benefit from a new Master Class, “Using Social Media Compliantly.” The one-day class, to be held Nov. 12 in Princeton, N.J., and Nov. 18 in Boston, is being offered by PhillyCooke Consulting and will enable attendees “to take […]
Read moreJune 23, 2014 – Although the two social media draft guidance documents the FDA’s Office of Prescription Drug Promotion (OPDP) issued June 17 do not exactly establish any new marketing policy, they do help industry to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 […]
Read moreJune 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 […]
Read moreJune 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 […]
Read moreJune 27, 2011 — The Food and Drug Administration (FDA) should move forward with its social media/Internet guidance and not wait for the results of the three studies it recently announced it would conduct to test benefit and risk information presentations on direct-to-consumer (DTC) prescription drug Web sites, according to comments submitted to the FDA […]
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