Drugs

Some ‘Thawing’ in FDA Drug Communication Approach: Attorneys

Three Akin Gump attorneys say that examples included in an FDA draft guidance on consistent communications “appear to signal a slight thawing in FDA’s approach to communications made related to drugs, particularly with respect to information about longer-term safety and efficacy, specific patient subgroups, patient-reported outcomes, and mechanism of action.” The guidance was issued in the waning days of the Obama administration, and the attorneys say in an online post that it will be up to the Trump administration to decide whether to pull it or continue to receive comments.

The guidance says that a communication is only consistent with the FDA-required labeling if it meets all of three factors involving comparisons to conditions of use in the required labeling, potential to harm health, and comparison to directions for use. It cites examples of communications that would pass the test of consistence and those that would fail.

A draft guidance on payer communications does not limit the methods for communicating competent and reliable scientific evidence, which could be conveyed in an evidence dossier, journal report, software, budget model, or another form, the attorneys write. The draft also addresses communication of healthcare economic information relating to unapproved medical products such as investigational drugs and medical devices.

The post covers two other items released by FDA at the same time — a memorandum on communications and the First Amendment and a final rule on the definition of “intended uses.”

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