Quality care gap for children with intellectual disabilities getting antipsychotics

Abstract

When Scott Gottlieb, M.D., resigned as commissioner of the Food and Drug Administration in March, the vaping industry breathed a collective sigh of relief. And indeed, shortly after his resignation, the FDA appeared to refocus on one particular type of electronic cigarettes, prioritizing enforcement of products that “pose a greater risk for minors to access” — namely, to focus on flavored (except for mint or menthol) tobacco products that attract young people. The basic framework of the policy is the same — to make it more difficult for future generations to become addicted to nicotine, but in particular, the vision is one in which combustible cigarettes are replaced by e-cigarettes. “This plan puts nicotine at the center of our regulatory efforts,” said Gottlieb just before he left office, but after he had tendered his resignation. “It seeks to regulate nicotine levels in combustible cigarettes to render them minimally or non-addictive. At the same time, we’re advancing new policies to encourage the development of products that can deliver nicotine to currently addicted adult smokers without all of the harmful effects of combustion, including novel forms of medicinal nicotine replacement therapy.” E-cigarettes could conceivably be one of these forms. “However, it has become clear that a recent surge in e-cigarette use among youth, which had appeared to be leveling off at the time our comprehensive plan was first announced in July 2017, is threatening the progress we’ve made in reducing youth tobacco use,” said Gottlieb. “The most recent data show more than 3.6 million middle and high school students across the country were current (past 30 day) e-cigarette users in 2018. This is a dramatic increase of 1.5 million children since the previous year. The data also showed that youth who used e-cigarettes also were using them more frequently and they were using flavored e-cigarette products more often than in 2017. This is particularly troubling given that research shows that kids using ecigarettes are more likely to take up combustible cigarettes.” Evidence shows that youth are especially attracted to flavored e-cigarette products, and that minors are able to access these products both from brickand-mortar retailers and online. So, in the future, the FDA is aiming to get some flavored e-cigarette products out of the marketplace altogether. “Specifically, today, with the strong support of the Secretary of Health and Human Services Alex M. Azar, and President Donald J. Trump, the FDA is proposing to end our current compliance policy as it applies to flavored electronic nicotine delivery system (ENDS) products (other than tobacco-, mint-, and menthol-flavored),” Gottlieb announced March 15. “Under the proposed policy announced today, we’re putting all manufacturers and retailers on notice: you may be subject to FDA enforcement for selling certain flavored ENDS products without authorization. We’ll prioritize enforcement to prevent the access and appeal of these products to kids.” For more information, go to: • h t t p s : / / w w w . f d a . g o v / To b a c c o P r o d u c t s / L a b e l i n g / R u l e s R eg u l a t i o n s G u i d a n c e / ucm633280.htm • h t t p s : / / w w w . f d a . g o v / T o b a c c o P r o d u c t s / P u b l i c H e a l t h E d u c a t i o n / Pro tec t ingKidsf romTobacco/ ucm608433.htm ▪ FDA From the ReseaRch BRief