FDA Policy/General

Create ‘Drug Facts’ Box for DTC Ads: Column

With FDA apparently taking a more aggressive stance on direct-to-consumer (DTC) drug ads, two academic researchers call in a Washington Post opinion column for the agency to create a “Drug Facts” box to go with ads. The column says that DTC ads “almost always fail to communicate what consumers most need to know — how well a drug actually works.”

The writers say consumers need to understand the size of a drug’s benefit and know about possible harms.

“This presents an enormous opportunity for FDA to help,” the column says. “Unless consumers learn how big the risks and benefits are, a drug ad simply has not informed them. And the only way to know if an ad has succeeded is to show it to people and see what they take away from it. If FDA is serious about improving drug ads, it should require these tests before ads can be released.”

Arguing in favor of a Drug Facts box, the writers say FDA already has all the information needed to go into such a box because it is the same evidence that companies provide when they apply for drug approval.

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