FDA Policy/General

Patients Don’t Want Relationships with Drug Firms: Blogger

An online World of DTC Marketing blog post by marketing consultant Richard Meyer says that consumers and patients don’t want a social media relationship with drug companies. Responding to changes Facebook is making to become more attractive to drug companies, the author says they won’t work because they run counter to what consumers want. The blog says that new Facebook community pages to bring together users who share a medical condition could be sponsored by drug makers, which often market a product to treat the condition. “This despite the fact that patients do not want users of Facebook knowing that they have medical problems,” Meyer says.

The author also complains that not allowing comments on drug Facebook pages because the drug companies are afraid out adverse event reporting “is contrary to everything social media is supposed to be. Yet, users have told brands to ‘leave me alone’ on their Facebook feed unless you’re an iconic brand like Starbucks or Trek bikes.”

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