Drugs

FDA Changes Off-Label Approach: Attorney

Attorney Dara Katcher Levy (Hyman, Phelps & McNamara) says an FDA 10/23 draft guidance on communications from firms to healthcare providers about scientific information on unapproved uses of approved/cleared medical products represents a shift in the agency’s approach. Writing in her firm’s online FDA Law Blog, Levy says the guidance introduces two new concepts about the information industry may choose to disseminate under this “safe harbor.” They are (1) application to firm-generated presentations of scientific information, and (2) material that meets a new evidentiary standard — scientifically sound and clinically relevant.

Levy writes that the agency acknowledges that firms may develop presentations of scientific information from an accompanying reprint. “Firm-generated communications must meet the general recommendations in the draft guidance and ‘should be truthful, non-misleading, factual and unbiased and provide all information necessary for healthcare providers to interpret the strengths and weaknesses and validity and utility of the presented information…,’” she says.

The presentation should be accompanied by the reprint, Levy says, and the reprint must meet the guidance’s criteria for reprints.

The post says FDA’s position that presentations must be scientifically sound and clinically relevant is a departure from its past approach that articles about unapproved uses of approved products must describe adequate and well-controlled clinical investigations. “Throughout the guidance,” Levy writes, “FDA refers to studies and analyses, suggesting that publications may cover more than a description of an adequate and well-controlled clinical trial. FDA notes that real-world data and associated real-world evidence may be scientifically sound and clinically relevant depending on the circumstances.”

Levy concludes that the new guidance “may leave industry with the feeling that it still hasn’t found what it is looking for in terms of FDA’s attempts to strike the right balance.”

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