Drugs

PhRMA Concerns with Proprietary Name Study

Pharmaceutical Research and Manufacturers of America (PhRMA) says it is concerned that a planned FDA study of promotional implications of proprietary prescription drug names “will not produce data that will appropriately inform or meaningfully improve FDA’s regulation of proprietary drug names and, therefore, that it will not provide information that has practical utility or that is necessary to the proper performance of FDA’s functions. The association’s comment letter says PhRMA has concerns with the survey design and the inclusion of several questions in the questionnaire.

If the agency proceeds with the study, the letter says, PhRMA recommends changes to the study design so that the study:

more closely mimics real-world conditions under which healthcare providers and patients form impressions of proprietary names;
limits questions to those that serve the survey stated objectives;
eliminates bias in the questions and gives participants a “no impression” response option;
collects responses from an appropriately sized and targeted sample; and
involves conducting a pre-test and qualitative follow-up to further refine the survey and understand the data collected.

PhRMA also recommends that FDA clarify the survey’s purpose and intended use of the data, saying it is unclear whether the agency intends to use the survey data to inform changes to its regulation of proprietary names, justify agency decisions, support a more flexible approach to proprietary name review, or for some other reason.

The association also calls on FDA to fully consider the First Amendment protections afforded to proprietary names “to avoid chilling truthful, non-misleading speech in crafting and executing any survey and using any resulting data.”

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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