Tag: Henry Miller

  • Analysis of Potential Nominees for U.S. FDA Leadership

    Analysis of Potential Nominees for U.S. FDA Leadership

    As the Biden administration engages the COVID-19 pandemic, a public tug-of-war has emerged over who should be nominated to run the Food and Drug Administration, a pivotal participant in the effort, write Henry I. Miller and Jeff Stier for Issues & Insights. An analysis of the two perceived front-runners illustrates that neither would likely introduce the kinds of reform needed at the agency.

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    Jeff Stier / senior fellow at the Consumer Choice Center

    One candidate is acting Commissioner Dr. Janet Woodcock, a long-serving top FDA official with widespread institutional respect, both inside and outside the agency.

    To her (far) left is Dr. Joshua Sharfstein, who served briefly as deputy commissioner of the FDA in the Obama administration, and who formerly was the secretary of the Maryland Department of Health, as well as the health commissioner in Baltimore. Earlier in his career, Sharfstein was the health policy adviser to influential, liberal Congressman Henry Waxman, D-Calif. He is currently the vice dean for Public Health Practice and Community Engagement at the Johns Hopkins Bloomberg School of Public Health.

    Woodcock’s strength is her extensive background in pharmaceutical regulation. However, some perceive her to be overly sympathetic to industry. Woodcock has been at the FDA for 35 years, and would be a sober, steady influence at a time that cries for stability at the agency.

    But her institutionalism is also a weakness; all is not well at the FDA. As former Commissioner Frank E. Young quipped, “dogs bark, cows moo, and regulators regulate.” Consistent with that propensity, the FDA often exceeds its congressional mandate. Regulators have concocted additional criteria for marketing approval of a new drug beyond the statutory requirements for demonstrating safety and efficacy— requirements that sometimes inflict significant but obscure damage on both patients and pharmaceutical companies.

    For example, regulators have arbitrarily demanded that a new drug be superior to existing therapies, although the Food, Drug and Cosmetic Act requires only a demonstration of safety and efficacy. And in a classic case of regulatory mission creep, Phase 4 (post-marketing) studies are now routine, whereas the FDA used to reserve them for rare situations, such as when there were subpopulations of patients for whom data were insufficient at the time of approval.

    The effects of FDA regulators’ self-aggrandizing, excessively risk-averse actions range from the creation of disincentives to research and development (which inflates costs) to significant threats to public health, such as the years-long delay in approval of a much-needed meningitis B vaccine.

    Another egregious example of the impact of excessive risk-aversion is the saga of a drug called pirfenidone, used to treat a pulmonary disorder called idiopathic pulmonary fibrosis (IPF), which used to kill tens of thousands of Americans annually. The FDA unnecessarily delayed approval of the drug for years, although it had already been judged to be safe and effective and marketed in Europe, Japan, Canada, and China. (This deadly delay occurred on the watches of both Woodcock and Sharfstein.) As a result, more than 150,000 patients died of IPF in the United States, many of whom could have benefited from the drug.

    The agency’s handling of e-cigarettes over the last two administrations is a sorry illustration of how regulatory dilly-dallying undermines public health. The agency’s mealy-mouthed endorsement of vaping as only a “potential” tool for tobacco harm reduction for adult smokers failed to sufficiently encourage smokers to make the switch away from consuming nicotine in its deadliest form, the cigarette. As a result, not enough smokers have been using them, while too many kids have.

    Contrast this with Public Health England’s clear endorsement of using e-cigarettes to quit smoking, which has led to a sharp reduction in smoking without an epidemic of youth vaping. Woodcock would be unlikely to break the FDA’s mold in this space, while Sharfstein’s blind opposition to private sector-driven innovative solutions would likely shift e-cigarettes from a highly regulated marketplace to an illicit market like the one that caused the outbreak of pulmonary illnesses related to THC-vaping in 2019.

    The agency has become extremely top-heavy, with ever more boxes appearing at the top of the organizational chart, even though the vast majority of day-to-day oversight and regulatory actions are taken at the level of FDA’s various “centers” – Woodcock’s longtime perch, the Center for Drug Evaluation and Research, the Center for Food Safety and Nutrition, the relatively new Center for Tobacco Products, and so on. The FDA needs to be put on an organizational diet.

    If Woodcock is the institutional pick, Sharfstein would be the Ralph Nader pick. In fact, Sharfstein’s affiliation with failed nanny-state presidential candidates is more current than that. His academic affiliation with the Bloomberg School of Public Health is no coincidence. An outspoken advocate for expanding the scope of the FDA, which already regulates 20 cents of every consumer dollar, Sharfstein would have been the obvious pick for FDA commissioner, or even secretary of the Department of Health and Human Services, if former New York Mayor Michael Bloomberg’s multi-million-dollar presidential campaign had prevailed. Far from putting the agency on a diet, Sharfstein would instigate a regulatory feeding frenzy.

    What’s needed are structural, policy, management, and cultural changes that create incentives for the FDA to regulate in a way that is evidence-based and imposes the minimum burden possible. A number of possible approaches and remedies to accomplish that have been described, but neither Woodcock nor Sharfstein is likely to embrace any of them.

    We need significant legislative changes, or just conscientious congressional oversight, to disrupt the agency’s built-in bias for overregulation, but political realities make that unlikely anytime soon.

    Henry Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. A 15-year veteran of the FDA, he was the founding director of the agency’s Office of Biotechnology. Jeff Stier is a senior fellow at the Consumer Choice Center. Please follow them on Twitter at @henryimiller and @JeffAStier.

  • Stier: E-cigarette Bans Would Harm Public Health

    Stier: E-cigarette Bans Would Harm Public Health

    Public health policy should be guided by science, data and a large dose of common sense. The promised benefits of any policy should be weighed against the known risks and possibility of unintended consequences.

    Last February, the House of Representatives passed legislation that would ban the sale of flavored e-cigarettes to adults. The bill, sponsored by Rep. Frank Pallone Jr., D-N.J., did not advance in the Senate, but is sure to rear its draconian head in the next Congress, write public health experts Jeff Stier and Henry Miller.

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    Jeff Stier / senior fellow at the Taxpayers Protection Alliance

     

    The prohibition of the legal sale of flavored e-cigarettes to adults is not supported by science, is undermined by an analysis of the available data, and lacks common sense.

    Federal law already bans the sale of all e-cigarettes to anyone under 21, so the Pallone legislation would only change the legal status of the sale of flavored e-cigarettes to adults. That would harm public health, because the data tell us that adult smokers can significantly reduce their health risks if they switch from smoking to vaping. Vaping exposes users to fewer toxic chemicals than smoking cigarettes, and a British study found that long-term cigarette smokers who switched to vaping were halfway toward achieving the vascular health of a non-smoker within a month.

    And because e-cigarettes are estimated to be 95 percent less harmful than cigarettes, according to Public Health England, they can be a boon to public health if adult smokers are able to completely and permanently make the switch. But achieving long-term benefits from the shift to vaping from cigarettes requires adherence, and survey after survey has found that adult smokers are better able to maintain the switch if they use flavored vaping products.

    Flavors play a critical role in helping smokers quit. A 2018 study published in the Harm Reduction Journal found that, “Adult frequent e-cigarette users in the USA who have completely switched from smoking cigarettes to using e-cigarettes are increasingly likely to have initiated e-cigarette use with non-tobacco flavors and to have transitioned from tobacco to non-tobacco flavors over time.” The authors concluded that e-cigarette flavor bans “may discourage smokers from attempting to switch to e-cigarettes.”

    The U.S. Food and Drug Administration (FDA) is aware of the potential life-saving nature of e-cigarette flavors, noting that “certain flavors may help currently addicted adult smokers switch to potentially less harmful forms of nicotine-containing tobacco products.”

    But what about kids using flavored e-cigarettes?

    Recent survey data from the U.S. Centers for Disease Control CDC) reinforces what we’ve known for a long time: Kids are curious and experiment with risky products. But it’s not the flavors that induce teens to vape. According to the 2019 National Youth Tobacco Survey, fewer than a quarter of teens who ever used e-cigarettes cited the availability of flavors as a reason for using them.

    Although adults and youth equally prefer flavored e-cigarettes to those with tobacco flavor, adults quit smoking in large part because of flavors. Kids vape for lots of reasons, but the availability of flavors isn’t high among them.

    Therefore, banning the sale of flavored e-cigarettes to adults in order to prevent youth vaping would be detrimental to public health overall. It would do little, if anything, to curb youth vaping, while it would make it harder for adults to quit smoking.

    As misguided as the legislation was when the House voted for it in February, it is even more inappropriate today, now that the Sept. 9 deadline for e-cigarette manufacturers to submit pre-market tobacco applications (PMTAs) to the Food and Drug Administration has passed. As of that date, it is illegal to sell e-cigarettes whose manufacturer has not submitted to the FDA a substantial (and costly) application for each individual product it wishes to sell.

    E-cigarettes that are the subject of these applications must meet stringent conditions, including: (1) “[r]isks and benefits to the population as a whole, including people who would use the proposed new tobacco product as well as nonusers”; (2) “[w]hether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available”; and (3) “[w]hether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available.”

    Because every vaping product, flavored or not, must already meet an extraordinarily high bar, there is no valid rationale for preempting the judgments of FDA scientists and, instead, letting politicians dictate them, as the Pallone bill would do.

    If current regulation, supplemented by unprecedented taxpayer-funded education campaigns, doesn’t prevent kids from vaping, there’s no reason to believe they won’t turn to even riskier products in a flourishing black market spawned by a flavor ban.

    Jeff Stier is a senior fellow at the Taxpayers Protection Alliance. Henry I. Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. He was a research fellow at the National Institute of Child Health and Human Development and the founding director of the FDA’s Office of Biotechnology.