FDA Policy/General

‘False, Misleading Claims’ in Sprout Addyi Radio Ad: OPDP

The CDER Office of Prescription Drug Promotion (OPDP) says a radio ad for Sprout Pharmaceuticals’ Addyi (flibanserin) tablets makes false or misleading claims about the drug’s risks and omits other material facts. An 8/31 Warning Letter says the violations “are concerning from a public health perspective because they create a misleading impression about the safety and effectiveness of Addyi, a drug that bears a Boxed Warning due to the risk of severe hypotension and syncope in certain settings.”

Addyi is indicated for treating premenopausal women with acquired, generalized hypoactive sexual desire disorder under specified conditions, FDA says. It is not indicated for use in postmenopausal women or men and is not indicated to enhance sexual performance. The drug labeling contains a Boxed Warning about hypotension and syncope in certain settings.

The OPDP letter notes 2016 advisory comments to Valeant Pharmaceuticals and says “we are concerned that, in the radio ad, Sprout is continuing promotion of Addyi in a manner that does not adequately convey the FDA-approved indication nor the important risk information for the drug.”

OPDP says the radio spot includes numerous claims and presentations about the benefits of using Addyi for acquired, generalized hypoactive sexual desire disorder in premenopausal women but completely omits all Contraindications associated with its use. It also fails to disclose some important information from the Boxed Warning, the letter says, and omits specific Warning and Precaution information from the label.

OPDP asks that Sprout immediately stop misbranding Addyi and/or cease introducing the misbranded drug into interstate commerce. The company was told to respond with a list of all violative promotional materials and its plan for discontinuing their use. It also says the company should provide a comprehensive plan to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in the letter to the audience that received the violative promotional material.

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

Read more

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