Nov. 2, 2020 – After 27 years with the Office of Prescription Drug Promotion (OPDP) – formerly called the Division of Drug Marketing, Advertising, and Communication (DDMAC) – OPDP Director Tom Abrams retired from the agency on Oct. 23 as the primary force behind today’s regulation of prescription drug advertising and promotion. Abrams’ leadership shaped […]
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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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Oct. 4, 2018 – According to Center for Drug Evaluation and Research (CDER) Director Dr. Janet Woodcock, the FDA’s Office of Prescription Drug Promotion’s (OPDP’s) decreased number of enforcement actions is largely due to the agency’s concerns regarding First Amendment issues that have been raised in recent court rulings. Speaking at a Sept. 21 discussion […]
Read more July 2, 2018 – The FDA’s Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter in 2018 to Pfizer Inc., claiming that a direct-to-consumer (DTC) video for the ESTRING® (estradiol vaginal ring), posted on the michiganmomliving.com site, as well as prepared Q&As provided to interview participants (and submitted to the agency under Form […]
Read more June 14, 2018 – Although they may not be perfect, the two final guidance documents issued this week by the FDA do provide more information and examples to help pharma companies navigate how they communicate with payors and how they ensure that their on-label communications are compliant. In a June 12 statement, FDA Commissioner Scott […]
Read more May 21, 2018 – Since the Trump administration presented its proposal to lower drug pricing on May 11, both the trade and mainstream media have been discussing whether one provision – a request that the Department of Health & Human Services evaluate the inclusion of drug prices in consumer ads – really has legs. In […]
Read more Aug. 11, 2017 – The results of a recent study conducted by the FDA and RTI International has concluded that a revised, briefer risk statement in broadcast direct-to-consumer (DTC) ads improves risk and benefit recognition and risk recall. As such, a move toward communicating a limited number of risks and including a disclosure alerting consumers […]
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May 31, 2017 – New FDA Commissioner Scott Gottlieb’s initial tasks largely will be administrative, according to Wayne Pines, healthcare president at APCO Worldwide and former FDA associate commissioner for public affairs, who spoke at a May 16 session of the Coalition for Healthcare Communication Rising Leaders Conference for Healthcare Policy, held in Washington, D.C. […]
Read more March 20, 2017 – Although medical marketers are very familiar with Scott Gottlieb, President Donald Trump’s choice for the top job at the FDA and a former FDA deputy commissioner for medical and scientific affairs, they can only make educated guesses about how he will run the agency of 14,000 people and what his positions […]
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Dec. 6, 2016 – When the dust settles post-inauguration, the Trump administration likely will be considering how it might want to change the FDA, and APCO Worldwide’s Wayne Pines recently put forward “six important ideas” about the agency and its mission in Morning Consult to help the Trump team frame its future decisions. These ideas, […]
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