FDA Policy/General

Doctors Irked by Virtual Detailing in Pandemic: Indegene

Pharmaceutical consulting firm Indegene says doctors are expressing discontent with elements of the virtual drug detailing forced by the pandemic, although they also are not very pleased with in-person detailing. In an online white paper, Indegene reports that one in three healthcare professionals is dissatisfied with contacts with drug companies through social media (49%), marketing e-mails (46%), and phone calls with sales representatives (42%). However, in-person meetings with sales representatives are disliked by 33% and remote meetings are disliked by 34%.

Indegene CEO Manish Gupta says the problems stem from the slowness and siloization of the various communication channels. He says that with the pandemic, drug companies have an opportunity to take a more deliberate approach to addressing the pain points cited by doctors.

Gupta says that drug companies sell content, noting that nobody approves, prescribes, or takes a drug without looking at data or some other content prior to decision-making. But, he says, the content is split into many silos—clinical trials, regulatory, safety, medical affairs, and commercial. While a doctor may have some connection with each of the content silos, the final experience is not necessarily the sum of all the connections.

“If the overall experience is not unified,” Gupta says, “the physician doesn’t have a positive experience.” He says the various silos all need to come together and be distributed at the ideal moment, with the right level of personalization, and in the appropriate channel. Some Indegene clients, Gupta says, have started to use modular sets of content, where discrete content bites are pre-approved, as are the rules by which they can be assembled for messaging.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome