Analysis of FDA's Vuse market authorisation: limitations and opportunities.

This special communication provides a physicians' critique of the US Food and Drug Administration (FDA)'s decision to authorise the Vuse Solo (Vuse) Premarket Tobacco Application (PMTA). The PMTA authorisation represents the first time that FDA has authorised an Electronic Nicotine Delivery System (ENDS) for marketing in the USA. Using the FDA Decision Summary, the special communication identifies significant unanswered public health and scientific questions that prevent the authors from reaching FDA's conclusion that Vuse meets the Appropriate for the Protection of the Public Health (APPH) standard. The authors recommend FDA suspend the market authorisation and use these questions to re-evaluate the PMTA, and to prospectively monitor whether Vuse meets APPH standard. The special communication advances the ENDS harm reduction conversation because it calls for national tobacco regulators to develop an epidemiological prediction of ENDS impact on the population and to expand the scope of their analysis to evaluate the impacts of ENDS on congenital birth defects, abuse liability and non-flavour drivers of youth usage. Through learning from the American experience regulating Vuse, national tobacco regulators around the globe will be better equipped to evaluate the impact of ENDS on the public health.

Electronic nicotine delivery systems: the need for continued regulatory innovation.

The recent surge in electronic nicotine delivery systems (ENDS) or electronic cigarette use among both adolescents and adults challenged tobacco regulatory frameworks worldwide. In this article, we review recent US Food and Drug Administration regulatory approaches to tobacco products, including attempts to regulate nicotine concentration and address youth use. We examine recent drives to promote a harm reduction approach in other product markets such as opioids, where the use of methadone and related therapies promote the public health. We describe the potential of a harm reduction framework for ENDS regulation based on tiered nicotine exposure standards coupled with risk-based product distribution controls that would enable ENDS products to meet the 'Appropriate for the Protection of the Public Health' standard required for tobacco product market entry. A harm reduction approach to ENDS regulation could help countries achieve the laudable public health goals of transitioning existing combustion cigarette users to ENDS products while preventing adolescent ENDS use and subsequent nicotine addiction.

Financing Preventive Medicine Graduate Medical Education.

Financing US preventive medicine residency programs has been a persistently difficult issue. The unique nature of preventive medicine renders training more burdensome and costly than other specialties. This article describes the numerous and varied federal sources of Graduate Medical Education funding to outline available residency financing options for the specialty of preventive medicine. This information could be utilized by various preventive medicine organizations in their efforts to strengthen the specialty.

Preventive medicine's equivalence problem.

The structure of preventive medicine residency training in the U.S. warrants serious examination. U.S. public health and general preventive medicine residencies have suffered a 17% decline in the number of residency programs since 2000, and current residency programs are, on average, half-empty. The required clinical year is not unique to preventive medicine, a basic, undifferentiated MPH for preventive medicine doesn't distinguish the preventive medicine specialist, and practicum year requirements are overly broad and not necessarily specific to the specialty, leaving the specialty vulnerable to equivalence by most other specialties. Strategies including creation of an additional preventive medicine-specific clinical year, developing a new public health degree for the specialty, and more specific practicum rotations, as well as potentially changing the specialty's name and altering the annual structure of training, are proposed along with an equivalence test.

Credentialing and privileging the preventive medicine physician.

The practice of preventive medicine remains ill-defined, and the specialty is threatened by a void in the definition of the specialty's practice. The authors propose a cohesive, active identification of skills provided by trained preventive medicine physicians through the credentialing and privileging process. The privileging process should incorporate clinical skills specific to the provider and non-clinical skills based on preventive medicine residency training competency requirements, preventive medicine board certification examination requirements, and the ten essential public health services. The specialty may benefit from development of clinical training based on public health clinical services as well as privileging of physicians in health organization leadership positions.

Do preventive medicine physicians practice medicine?

As some preventive medicine physicians have been denied medical licenses for not engaging in direct patient care, this paper attempts to answer the question, "Do preventive medicine physicians practice medicine?" by exploring the requirements of licensure, the definition of "practice" in the context of modern medicine, and by comparing the specialty of preventive medicine to other specialties which should invite similar scrutiny. The authors could find no explicit licensure requirement for either a certain amount of time in patient care or a number of patients seen. No physicians board certified in Public Health and General Preventive Medicine sit on any state medical boards. The authors propose that state medical boards accept a broad standard of medical practice, which includes the practice of preventive medicine specialists, for licensing purposes.