FDA Policy/General

Understanding Drug Risks and Benefits in Tweets

FDA and Fors Marsh Group researchers say they have examined the tradeoffs for consumer understanding of drug risks and benefits when drugs are promoted in character-space-limited (CSL) communications such as tweets. “CSL communications present a challenge for maintaining fair balance between risks and benefits in direct-to-consumer prescription drug promotion,” the researchers write in an open-source Research in Social and Administrative Pharmacy article.

The objectives of the study were to examine the effects in four studies of (1) including substantive risk information in CSL communications versus only providing a link to risk information, and (2) including risks and benefits versus only risks in the linked landing page.

The researchers found that including the risk in the CSL communication increased the likelihood that participants would recognize the risk after the first viewing (three studies) and second viewing (four studies)

The researchers say their results may inform further development of regulatory policy. For instance, they say, the suggestion from the studies that including benefit information as well as risk information on a landing page does not detract from consumers’ understanding of risks may be relevant and important for regulators to consider when updating guidance. Second, drug companies and marketers may want to consider the results when developing and evaluating CSL-only campaigns. Finally, healthcare providers may want to take the findings into account when communicating risk information to patients and may consider providing direct search strategy guidance to patients when prescribing a new product.

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