Christian Saenz

Great conference this year at #SRNT2025 in New Orleans!

Thanks Charles!

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@jcmecon.bsky.social @econdarden.bsky.social
@DavidCGrabowski @melissawasserman.bsky.social
@Andy_SL_Tan @GaryGiovino @martymakary.bsky.social @MPEriksen @etterjf @ScottHalpernMD @Mikenber @justinwolfers.bsky.social @HuntAllcott @DrCaliff_FDA @AnupamBJena @drjbhattacharya.bsky.social @jeffstier

Thank you for reading! Please discuss your questions and comments in the replies below. @denverfrakes.bsky.social @dusetzinas.bsky.social @sangerkatz.bsky.social @crisdelnevo.bsky.social @gfong-waterloo.bsky.social @countthedead.bsky.social @cdcotti.bsky.social @scottgottliebmd.bsky.social 25/25

Our results should not be interpreted to suggest that drug deregulation or e-cigarettes are harmless. Without question, some people are harmed by both. But available evidence from this natural experiment suggests benefits sizably exceed costs. 24/25

Figure N1: Trends in High School Student Current (Past 30-Day) Tobacco Use

We discuss whether the mortality patterns may reverse as future generations age, and we find this highly unlikely. For example, tobacco use is lower among kids today than in 2011, and combustible cigarette use far lower. 23/25

Our work also contributes further quasi-experimental evidence that e-cigarettes have #PublicHealth benefit in terms of smoking cessation, and now, mortality reductions. We estimate that #ecig drug exemption through 2019 had about 1/3 the benefit of #HIV drugs through 2000. 22/25

Our paper makes many contributions. First, our paper suggests that the drug supply is over-regulated. Whether beneficial effects of drug deregulation experienced in the smoking cessation therapeutic drug class are generalizable to other classes of drugs is an open question. 21/25

We document consistent reductions in smoking after e-cigarette drug exemption, roughly a 6 percentage point reduction in current smoking cumulatively through 2019. 20/25

We also study the effect of e-cigarettes on #smoking using 3 data survey data sources (#BRFSS, #NHIS, #NSDUH). 19/25

We meanwhile find no evidence of mortality reductions from NRT introduction or #OTC status. The unregulated drug (#ecigs) leading to mortality reductions but the regulated drug (#NRT) not raises questions about FDA #effectiveness. @fda.gov @sangerkatz.bsky.social 18/25

Event studies shown above indicate the absence of time-varying confounding. Our results are also robust across a variety of specification checks. 17/25

Figure 4(b): Event Studies for Smoking-Attributable Mortality

We find that e-cigarette drug exemption in 2010 reduced smoking-attributable mortality by 10% on average from 2011-2019, saving 677,000 life-years. Most of these life year gains are from causes of death that are impacted relatively quickly after smoking cessation. 16/25

As a simplified example, White men living in rural areas have high smoking rates and Asian women living in urban areas have low smoking rates. Our empirical strategy tests for disproportionate impacts among White men compared to Asian women. 15/25

We use a dosage-response diff-in-diff design which leverages variation in daily-smoking rates prior to drug introduction. We study if introduction / exemption led to greater mortality reduction for higher smoking groups than lower smoking groups. @CharlieRafkin 14/25

We examine Rx NRT and OTC NRT introduction in 1984 and 1996, respectively. We also examine e-cigarette introduction in 2007 and drug exemption in 2010. 13/25

To study the effects of these products on mortality, we use all death certificates from 1975 to 2019, and study the 50% of mortality that is smoking-attributable mortality. 12/25

The rapid innovation in e-cigarettes after drug exemption compared to minimal innovation in NRT due to drug regulation have caused many people to perceive e-cigarettes as distinctively different products today. 11/25

In contrast, FDA-regulated NRTs evolved at a far slower pace. The first NRT product released was 2-mg gum in 1984. It took 9 years before it could be sold with a higher strength, 12 years to be sold OTC, and 15 years for it to be flavored. 10/25

Figure 1(b): Historical Patent Applications”

We find drug exemption led to e-cigarette #patent applications skyrocketing in the #USA relative to #Australia, where restrictive e-cigarette regulation was largely unchanged during this time period. 9/25

Is the Food And Drug Administration Safe And Effective? (Winter 2008) - In the United States, the Food and Drug Administration (FDA) provides public oversight of the safety and efficacy of drugs; medical devices; biologics like vaccines and blood products;...

The #ecig drug exemption provides a glimpse of a world without drug regulation but with product liability law. This allows us to test Tom Philipson and Eric Sun’s theory that #product #liability law is sufficient for a well-functioning marketplace. aeaweb.org/articles?id=... 8/25

FDA drug regulation can be thought of as a trade-off between evaluating drug effectiveness/safety, and speed with which new drugs are brought to market. #MedTwitter #MedSky #PharmTwitter #healthpolicy #Pharmsky 7/25

The D.C. District Court ruled in 2010 that per the 2009 Tobacco Control Act, the FDA could not pre-emptively regulate e-cigarettes as a drug. This was unexpected. It is the only time the FDA has been rebuffed in attempting to regulate a new product as a drug. 6/25

President Obama signing the Family Smoking Prevention and Tobacco Control Act” into law on June 22, 2009

However, the Tobacco Control Act (#TCA) was passed shortly after the FDA began seizures, which contained language unexpectedly upsetting the FDA’s legal argument framed around Congressional intent. 5/25

The FDA began seizing imports of e-cigarettes in 2009, declaring them as an unauthorized drug. FDA's #SCOTUS-validated legal strategy allowed them to previously clear the market of other unapproved nicotine products like nicotine water, Favor smokeless cigarettes, etc. 4/25

Ruyan V8

The first e-cigarettes were imported to the U.S. in 2007, starting with the Ruyan V8. The Ruyan V8 was similar to FDA-approved nicotine inhalers in terms of nicotine content, being unflavored, and smoking cessation effectiveness. 3/25

We compare effects to nicotine replacement therapy (#NRT) that has been consistently regulated as a drug. Essentially, we study mortality effect differences in the introduction of an FDA-approved smoking cessation drug versus the exemption of another. 2/25

Abstract

What are the mortality effects of FDA drug regulation?
@mikepesko.bsky.social and I explore this using a unique natural experiment—e-cigarettes unexpectedly escaping #FDA drug regulation in 2010. The results may surprise you. 🧵 bit.ly/42w4xkG #EconSky #EpiSky #NIH #ecig #EconTwitter #EpiTwitter