Drugs

Don’t Conduct Proprietary Name Analysis: PhRMA

Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should not move forward with a proposed study on text analysis of proprietary name interpretations. The association’s 1/3 comment letter says it is concerned that the “proposed survey will not produce data that will appropriately inform or meaningfully improve FDA’s review of proprietary drug names and, therefore, it will not provide information that has practical utility or that is necessary to the proper performance of FDA’s functions.”

PhRMA recommends changes FDA could make to the methodology and questionnaire to help improve the research’s usefulness if the agency decides to proceed with it.

In its 12/20 comment letter, Lilly says it supports efforts to encourage the use of proprietary prescription drug names that do not misbrand the product. However, it says, it also has concerns about the proposed study and questionnaire. And it also expresses concern about how degrees or levels of misbranding may be established or standardized for evaluating proposed proprietary prescription drug names.

Lilly provides specific comments on the draft survey and includes information provided by an associate professor of integrated marketing communications and marketing in the Northwestern University schools of journalism and business.

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