Food And Drug Administration Commissioner Research Articles

Nicotine Gummies, Tablets Popular Among Adolescents

Back to table of contents Previous article Next article Clinical & ResearchFull AccessNicotine Gummies, Tablets Popular Among AdolescentsNick ZagorskiNick ZagorskiSearch for more papers by this authorPublished Online:24 Nov 2022https://doi.org/10.1176/appi.pn.2022.12.11.14AbstractA recent survey conducted at Southern California high schools found that over 3% of 9th and 10th graders have tried nontherapeutic nicotine gum, gummies, tablets, or lozenges.iStock/brazzoA recent survey of high schoolers in Southern California has found that nontherapeutic oral nicotine products such as tablets or gummies are popular among adolescents, ranking only second in use to e-cigarettes. The survey findings were published in Pediatrics.“Nontherapeutic nicotine gums, lozenges, tablets, and gummies have a number of features that could potentially attract youth,” said Alyssa F. Harlow, Ph.D., a postdoctoral scholar at the Keck School of Medicine at the University of Southern California (USC) who led the survey. “These products resemble candy and are highly discreet, making them easy to hide.” The act of popping a piece of gum or candy in the mouth might also feel less risky to an adolescent than inhaling nicotine, the researchers noted in the Pediatrics paper.The decision to add questions about nicotine products to an ongoing behavioral health survey of adolescents across seven school districts in Southern California arose after the researchers noticed increased marketing of these products on social media and other platforms. The survey included questions about nicotine pouches (which are placed in between the lip and gums like snus, but are filled with cellulose, nicotine salt, and flavorings rather than shredded tobacco), as well as nicotine gums, lozenges, tablets, and gummies.The youth were also asked about their use of combustible cigarettes, e-cigarettes, snus, cigars, little cigars or cigarillos, and hookahs or waterpipes.The researchers analyzed the responses of 3,516 9th and 10th graders who completed the survey between September 30 and December 14, 2021.Overall, e-cigarette use was the most prevalent among the respondents, with 9.6% of students reporting ever vaping and 5.5% vaping in the past six months. The use of oral nicotine products (not including nicotine pouches) was second most prevalent among the youth, with 3.1% of students reporting ever use and 1.4% reporting past six-month use.The reported use of all other products (including nicotine pouches) was lower than 1%. In the paper, Harlow and colleagues suggested pouches might seem less appealing to use or possibly more difficult to access than other nicotine or tobacco products. But as pouches are also heavily marketed and come in fruit flavors, continued monitoring of these products is also warranted, they wrote.“Since there have been no prior estimates of the use of these oral products, we had no exact idea of what to expect,” Harlow said. Still, she said her team was a little surprised to see that adolescents were using oral nicotine products more than other tobacco-based products.The researchers also found that the use of any oral nicotine product (including nicotine pouches) was more likely among Hispanic teens; females; and teens identifying as transgender, nonbinary, or a sexual minority.Shortly after the publication of the study, the Food and Drug Administration (FDA) issued its first warning letter to a company for illegally marketing flavored nicotine gummies without FDA authorization. In a statement, FDA Commissioner Robert M. Califf, M.D., acknowledged that these oral products “are a public health crisis just waiting to happen to our nation’s youth.” The company has since discontinued its line of flavored nicotine gummies.Harlow hopes her group’s findings serve as a call to action for groups involved in health surveillance. “National surveys documenting trends in the use of these oral products are a must,” she said. Such data could help researchers to better understand when youth start using these products, which groups are most vulnerable, and if use of oral products leads to other illicit substance use.Harlow and colleagues noted that in their analysis, over 77% of the adolescents who reported using oral nicotine products also reported a history of using other nicotine products, but the survey did not identify which products were initiated first.Richard Miech, Ph.D., M.P.H., a research professor at the University of Michigan Institute for Social Research, told Psychiatric News that beginning in 2023 many more high school students will be asked about use of nicotine products as part of the Monitoring the Future survey. Miech is the principal investigator for this national survey, which is funded by the National Institute on Drug Abuse.Miech thinks the use of these products has the potential to skyrocket, so his team is planning on watching the usage trends closely.This study was supported by awards from the National Cancer Institute; National Institute on Drug Abuse; National Heart, Lung and Blood Institute; and Food and Drug Administration Center for Tobacco Products. ■Resources“Adolescent Use of Flavored Non-Tobacco Oral Nicotine Products”The warning letter from the FDA ISSUES NewArchived

FDA Commissioner Talks Opioid Crisis, Health Disparities, AI Risks

FDA Commissioner Talks Opioid Crisis, Health Disparities, AI Risks

Global consequences of the US FDA's accelerated approval of cancer drugs.

The accelerated approval system is a fast-track drug approval pathway created by the US Food and Drug Administration (FDA) in 1992 in response to the HIV-AIDS crisis to allow expedited access to life-saving drugs and fulfil an unmet medical need. Nowadays, this pathway is most commonly used for cancer drug approval. 1 Sachs RE Gavulic KA Donohue JM Dusetzina SB Recent trends in Medicaid spending and use of drugs with US Food and Drug Administration accelerated approval. JAMA Health Forum. 2021; 2e213177 Google Scholar In theory, the accelerated approval pathway strikes a balance between early access to therapies and the need for robust evidence generation. This pathway allows drugs to be approved early on the basis of improvement in surrogate outcomes that are reasonably likely to translate to clinical benefit. This approval is conditional, with a mandate that drugs are tested in a post-approval confirmatory trial to substantiate the presumed clinical benefit, in the absence of which approval will be withdrawn. Several challenges and limitations of this pathway for the US regulatory and clinical environment have been previously described. 2 Gyawali B Ross JS Kesselheim AS Fulfilling the mandate of the US Food and Drug Administration's accelerated approval pathway: the need for reforms. JAMA Intern Med. 2021; 181: 1275-1276 Google Scholar Here, we discuss the often-overlooked consequences of the accelerated approval pathway for global oncology. Consequences of US FDA approval decisions in high-income countriesAkhade and colleagues1 highlight the global consequences of approving cancer medicines on the basis of uncertain evidence through the US Food and Drug Administration (FDA)'s accelerated approval pathway. Traditionally, the concern for US regulatory standards has remained inside the USA. However, Akhade and colleagues show that the consequences can be far reaching. Their Comment has substantial implications, especially considering the nomination of a new FDA commissioner and the opportunity that this nomination brings to enforce a suitable efficacy standard. Full-Text PDF

Generics and Biosimilars: Barriers and Opportunities

Generics and Biosimilars: Barriers and Opportunities

FDA moves to ban menthol cigarettes

Last week, the Food and Drug Administration (FDA) announced it is going to ban menthol cigarettes within the year. The decision is based on the addictiveness, not of menthol, but of the nicotine. For the same reason, the FDA banned all other flavored cigarettes in 2009. “Banning menthol—the last allowable flavor—in cigarettes and banning all flavors in cigars will help save lives, particularly among those disproportionately affected by these deadly products,” said acting FDA commissioner Janet Woodcock, M.D., on April 29. “With these actions, the FDA will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low‐income populations, and LGBTQ+ individuals, all of whom are far more likely to use these tobacco products.” Studies show that menthol increases the appeal of tobacco, especially among young people and Blacks. “For far too long, certain populations, including African Americans, have been targeted, and disproportionately impacted by tobacco use,” said Mitch Zeller, J.D., director of the FDA's Center for Tobacco Products. “Despite the tremendous progress we've made in getting people to stop smoking over the past 55 years, that progress hasn't been experienced by everyone equally.” H. Westley Clark, M.D., J.D., Dean's Executive Professor at Santa Clara University, told ADAW after the announcement that farmers should be incentivized to grow non‐tobacco products, stores incentivized to sell other products, and nicotine replacement and other therapies be made available. Taxation helps as well, as does limited access to the product, he said. The FDA said it will work with partners in other federal agencies to make sure the support is there for those who are trying to quit.

Race reporting and diversity in US food and drug administration (FDA) registration trials for prostate cancer; 2006\u20132020

BackgroundThere is significant racial disparity in prostate cancer (PCa) in terms of incidence, treatment, and outcomes. Racial diversity and compliance with FDA race reporting guidelines in PCa drug registration trials are unknown. We analyzed racial diversity and race reporting in drug licensing trials for PCa.MethodsNew drug authorizations for PCa from 2006 to 2020 were identified. The corresponding licensing trial publications were analyzed to check compliance with current FDA recommendations for race reporting. If race was unreported, the clinical trial report was analyzed to determine participant recruitment by race and lead the recruiting country.ResultsDuring the study period, 17 new drug registrations for the management of PCa involving ten unique drugs were identified. In total, 18,455 participants were included in FDA registration trials, of which 76.3% were white or Caucasian, 7.9% Asian, 2.9% Black or African American, 0.5% American Indian or Alaskan Native, 0.1% Native Hawaiian or other Pacific Islander, 1.8% other or multiple races and 10.5% unknown. 53% of trials reported race in the licensing publication, however of this only 55% met current FDA recommendations. When the race was unreported in the licensing publication, 88% of studies had further information in the clinical study report.ConclusionWe found a significant under-representation of non-white participants in FDA drug registration trials for PCa. Race reporting in licensing publication is inconsistent and both FDA and International Committee of Medical Journal Editors guidelines are not being universally followed. Given the disproportionality of the disease burden of PCa, recruitment of Black and other minority participants to trials should be a research priority.

Lessons Relearned? H1N1, COVID-19, and Vaccination Planning.

Lessons Relearned? H1N1, COVID-19, and Vaccination Planning.

Upsetting the apple CAR-T (chimeric antigen receptor T-cell therapy) - sustainability mandates USA innovation.

Seldom has a medical advance in cancer therapy been as pivotal as the advent of chimeric antigen receptor (CAR)-T-cell immunotherapy. While the first applications targeted the CD19 antigen on lymphoid malignancies, the incredible specificity of these 'living drugs', curative potential and generalisability to other targets have richly justified their declaration as 2019's breakthrough of the year by Science magazine. Two CAR-T products, Yescarta (axicabtagene ciloleucel) and Kymriah (tisagenlecleucel) were Food and Drug Administration (FDA)-approved in the USA in late 2017, with the FDA commissioner Scott Gottlieb heralding 'a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer'. Building upon early enthusiasm, nearly 1000 cell- and gene-therapy investigational new drug applications are pending with the FDA, which expects to review and approve between 10 and 20 such treatments annually by 2025. Despite the enormous promise and urgent unmet need fulfilled by CAR-T cells, the real-world adoption of the two FDA-approved treatments has been slow.

Characteristics and conflicts of interests of public speakers at the Psychopharmacologic Drug and Advisory Committee meetings regarding psychiatric drugs

The Psychopharmacologic Drug Advisory Committee (PDAC) is one of 33 advisory committees of the Food and Drug Administration (FDA). During committee meetings, an open public hearing takes place where speakers...

FDA Clears App to Help Retain Patients in Treatment for OUD

Experts in addiction and in digital technology say the app for opioid use disorder is an exciting development, but it remains to be seen if the technology will be widely used.

FDA Approves Powerful Opioid Amid Controversy Over Risks

FDA Approves Powerful Opioid Amid Controversy Over Risks

FDA Expands REMS Requirements for Opioids

Back to table of contents Previous article Next article Professional NewsFull AccessFDA Expands REMS Requirements for OpioidsNick ZagorskiNick ZagorskiSearch for more papers by this authorPublished Online:29 Oct 2018https://doi.org/10.1176/appi.pn.2018.11a14AbstractChanges to the Risk Evaluation and Mitigation Strategy (REMS) include several measures to help better communicate the serious risks about the use of opioids to patients and health care professionals.In September, the Food and Drug Administration (FDA) broadened its Risk Evaluation and Mitigation Strategy (REMS) program for opioids to include immediate-release opioid painkillers, in addition to extended-release and long-acting products. The opioid REMS now covers 347 painkillers, including the medications most commonly prescribed in outpatient settings.iStock/Moussa81In addition to expanding the painkiller list, the updated opioid REMS requires that the training be made available to all health care professionals who are involved in the management of patients with pain, and not only to those who prescribe the medication.A REMS is a drug safety program that the FDA can require for certain medications that have known safety concerns. The exact strategy varies with each drug, but often includes components such as requiring prescribers to have special certifications or requiring patients to be monitored regularly to support the safe use of that medication.The primary component of the opioid REMS is a requirement that all manufacturers of approved opioid analgesics provide unrestricted grants to accredited continuing education providers for the development of continuing medical education (CME) related to safe opioid prescribing.There is currently no mandatory federal requirement that prescribers or other health care personnel take these CME modules. However, the agency noted that its Opioid Policy Steering Committee is continuing to assess the landscape of opioid prescribing to see if there are circumstances when the FDA should require some form of mandatory education.The updated REMS will require that opioid-related CME materials now be made accessible to nurses, pharmacists, and others who are involved in the management of patients in pain. Given the larger audience, the FDA has also broadened the range of information that needs to be included in an opioid REMS. This includes more information on both acute and long-term pain management, including adding sections on pharmacological and non-pharmacological alternatives to opioid analgesics.“Providers have a critical role to play in making sure these products are appropriately prescribed to patients,” said FDA Commissioner Scott Gottlieb, M.D., in the agency’s press release. “Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain. This includes ensuring that prescriptions are written for only appropriate purposes and durations of use. Appropriate prescribing practices and education are important steps that we’re prioritizing to help address the human and financial toll of this crisis.”The agency also stated that it will require opioid analgesic manufacturers to include information about the availability of REMS-compliant education on the labels of all drugs intended for outpatient settings. The educational information will be listed in the “Boxed Warning” and “Warnings and Precautions” sections of the labels.The revised CME training materials for opioid painkillers are expected to be available to health care providers in the Spring of 2019. ■More information on the Opioid Analgesic Risk Evaluation and Mitigation Strategy can be accessed here. A listing of live and online CME courses is available on the Collaborative on REMS (CO*RE) website. ISSUES NewArchived

Denicotinised cigarettes

Preventing smoking is crucial to public health. Countries that implement the WHO Framework Convention on Tobacco Control MPOWER tobacco control policies, which include high taxes, marketing prohibitions, smoke-free policies, media campaigns, and treatment for addicted smokers, 1 WHOMPOWER in action. Defeating the global tobacco epidemic. http://www.who.int/tobacco/mpower/publications/mpower_2013.pdf?ua=1Date: 2013 Date accessed: June 13, 2018 Google Scholar can substantially reduce smoking prevalence. Such efforts are likely to be enhanced by the availability of consumer nicotine products, such as e-cigarettes, for use as smoking substitutes. 2 Tobacco Advisory Group of the Royal College of PhysiciansNicotine without smoke—tobacco harm reduction. Royal College of Physicians, London2016https://www.rcplondon.ac.uk/file/3563/download?token=Mu0K_ZR0Date accessed: June 13, 2018 Google Scholar However, since millions of smokers continue to die prematurely every year, and these deaths are avoidable, new policies to accelerate progress towards a world free from smoking are needed. In March, 2018, the US Food and Drug Administration (FDA) issued an advanced notice of proposed rule making, as part of its comprehensive plan on tobacco and nicotine regulation, 3 US Food and Drug AdministrationFDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htmDate: July 28, 2017 Date accessed: June 13, 2018 Google Scholar that proposes a radical approach: reducing the nicotine content of combustible cigarettes to minimally or non-addictive levels. 4 US Food and Drug AdministrationStatement from FDA Commissioner Scott Gottlieb, M.D., on pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels. US Department of Health and Human Services. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm601039.htmDate: March 15, 2018 Date accessed: June 13, 2018 Google Scholar , 5 US Food and Drug AdministrationTobacco product standard for nicotine level of combusted cigarettes. Federal Register. https://www.federalregister.gov/documents/2018/03/16/2018-05345/tobacco-product-standard-for-nicotine-level-of-combusted-cigarettesDate: March 16, 2018 Date accessed: June 13, 2018 Google Scholar Will it work?

Journal Club - Asthma/Chronic Obstructive Pulmonary Disease Overlap: Fact or Fiction?

With the development of biologics and the advent of “precision medicine” there is great interest in defining phenotypes and indeed endotypes that may identify responders based on clinical characteristics and/or underlying biological mechanisms. Recently, the Food and Drug Administration (FDA) voted against approval of mepolizumab for use in chronic obstructive pulmonary disease (COPD) stating that there was insufficient evidence to support mepolizumab as an add-on therapy for COPD patients guided by eosinophil levels. The FDA committee pointed to a lack of consensus over the definition and possible relevance of a so-called “eosinophilic COPD phenotype.” They pointed to the variability in blood eosinophils making it a challenge to use it as a potential marker to identify appropriate candidates for therapeutic trials. The committee recommended greater research with larger numbers and better patient characterization, including more female patients, (an important recommendation particularly given that women are known to have higher rates of airway hyper-responsiveness than men). Refining the characterization of the asthma/COPD overlap (ACO) group is key to moving forward in studying the use of biologics in this population. Recent studies have pointed to the benefits of long-acting muscarinic antagonists (LAMA) bronchodilators, originally only indicated for COPD, to be efficacious in some asthma patients (tiotropium has been approved by the FDA for asthma and COPD).1,2 Conversely, there have been several trials that have looked at the use of TH-2 pathway biologics typically reserved for asthma patients, (omalizumab,3 mepolizumab4-6and benralizumab7), in COPD patients thought to demonstrate potential overlap features (history of allergies, elevated immunoglobulin E [IgE], high eosinophil counts, asthma history, smoking history, partial reversibility). The various criteria used to define the ACO group have typically utilized some combination of these features. This is the backdrop for reviewing several recent papers that have focused on assessing the prevalence of ACO according to different ACO criteria and/or examined various potential clinical characteristics and/or biomarkers that may lead to greater discrimination in defining the potential endotypes within the ACO group. I present this particular collection of recent studies from this year mostly to demonstrate the highly variable, (and in some instances questionable), criteria for defining ACO patients. With more biologics for airway disease in the pipeline it is critical that we further refine our precision in defining the heterogeneity of the endotypes (or treatable traits) within the ACO group for better patient selection in clinical trials. Note: Abstracts are presented in their original, published format and have not been edited to match JCOPDF style.

Med Check

Med Check

Asociaciones de pacientes y autorización de nuevos fármacos en Estados Unidos. El caso del eteplirseno para la distrofia muscular de Duchenne

In 2016 the US Food and Drug Administration (FDA) granted the marketing authorization for eteplirsen for Duchenne muscular dystrophy. This has been a very controversial decision since it happened after a negative assessment from both the Advisory Committee and the technical FDA evaluation team. The FDA's Center for Drug Evaluation and Research (CDER) director was who ultimately approved the product, while the FDA Commissioner did not overrule that decision. To report about the most relevant events regarding the approval of eteplirsen by the US FDA. All relevant facts that occurred during the clinical development and evaluation phase following 'accelerated approval' procedure of eteplirsen are discussed in detail. The technical FDA evaluation team reasons supporting that the drug has not proven clinical benefit, the attitude of patient advocacy groups and the post-approval FDA requirements to the marketing authorization holder are discussed. Finally, we reflect on what is the situation Spanish patients face once eteplirsen is on the US market. This is a unique case in the history of drug authorizations in western countries, that shows the difficulties that current regulations on accelerated approval of new medicines could have when interpreting scarce and low quality clinical development data, when dealing with rare diseases with no available therapies.

A Major Shortcoming in the Public Health Legacy of the Obama Administration.

The author reflects on U.S. President Barack Obama's public health legacy in relation to the practices of America's Food and Drug Administration (FDA) during Obama's tenure as the nation's leader. The FDA's approval of medical products based on lower standards of scientific evidence is examined, along with FDA Commissioner Margaret Hamburg's promises regarding the agency's approval process and governmental transparency. FDA reforms of medical device standards are assessed.

Investing in our future: Update on the SCAI Emerging Leader Mentorship (ELM) Program.

Investing in our future: Update on the SCAI Emerging Leader Mentorship (ELM) Program.

The US Food and Drug Administration and Cardiovascular Medicine: Reflections and Observations.

The US Food and Drug Administration (FDA) is a remarkable hybrid. Part regulatory agency, part public health agency, it sits at the intersection of science, law, and public policy. The FDA’s mission can be considered in the context of 2 broad dimensions: the products it regulates and its core functions. Both fall under the rubric of protecting and promoting the public health. The FDA’s remit is both broad and diverse: altogether, the agency has regulatory responsibility for >20% of the US economy. The products it is charged with overseeing through its various centers1 encompass food and cosmetics (regulated by the Center for Food Safety and Applied Nutrition); food and drugs for animals, including companion animals and animals used for food (regulated by the Center for Veterinary Medicine); and medical devices, drugs, and biologics (regulated by the Centers for Devices and Radiological Health, Drug Evaluation and Research, and Biologics Evaluation and Research, respectively). Tobacco products were added to the FDA’s portfolio by the Tobacco Control Act of 2009, and are overseen by the Center for Tobacco Products. Regardless of the specific product regulated, the FDA’s core mission remains the same: to protect the US population by helping to ensure the fundamental safety of the food Americans consume and the medical products prescribed by their clinicians. At the same time, this primary mission is complemented by a mandate to promote the public health by reviewing research and taking appropriate action on the marketing of regulated products in a timely manner. Not only do people need access to advances in nutrition and medical therapies, but also the American spirit is itself characterized by a strong current of scientific and technological innovation. At first glance, differences in these 2 priorities, protecting the public safety and promoting the public health through encouraging innovation, might …

Robert Califf, M.D., Confirmed as FDA Commissioner

Robert Califf, M.D., Confirmed as FDA Commissioner