FDA Policy/General

OPDP Cites Exeltis’ Promos on Social Media

CDER Office of Prescription Drug Promotion (OPDP) has cited Florham Park, NJ-based Exeltis USA for making in a social media post false or misleading claims and representations about the risks and efficacy of its contraceptive Slynd (drospirenone) tablets. OPDP also cited the firm for not submitting its promotional materials at the time social media posts were made, according to an just-posted untitled letter to the company.

The letter says the post was misleading because it failed to communicate any risk information. “By omitting the risks associated with Slynd, the post fails to provide material information about the consequences that may result from the use of Slynd and creates a misleading impression about the drug’s safety,” OPDP says.

Additionally, OPDP takes issue with the post’s claim: “Offer your patients estrogen-free birth control with periods on a schedule.” This overstates Slynd’s efficacy because it claims that patients will have a “period,” or bleeding, that is predictable and “on a schedule” when this has not been demonstrated, the letter says. It adds that Slynd’s package insert admits that “scheduled bleeding” decreased over time (from 98.0% in Cycle 1 to 28.4% in Cycle 13).

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