scholarly journals Should Graphic Warning Labels Proposed for Cigarette Packages Sold in the United States Mention the Food and Drug Administration?

2020 ◽  
Author(s):  
Mia Jovanova ◽  
Chris Skurka ◽  
Sahara Byrne ◽  
Motasem Kalaji ◽  
Amelia Greiner Safi ◽  
...  
Keyword(s):  
Middle School ◽  
Tobacco Control ◽  
Drug Administration ◽  
Source Credibility ◽  
Food And Drug Administration ◽  
The United States ◽  
Smoking Prevention ◽  
Warning Labels ◽  
The Us ◽  
Graphic Warning

Abstract Introduction Under the US Family Smoking Prevention and Tobacco Control Act, the US Food and Drug Administration (FDA) has the authority to implement graphic warning labels (GWLs) on cigarette packages. Neither the original labels proposed by the FDA nor the revised labels include a source to indicate sponsorship of the warnings. This study tests the potential impact of adding a sponsor to the content of GWLs. Methods We recruited adult smokers (N = 245) and middle-school youth (N = 242) from low-income areas in the Northeastern US. We randomly assigned participants to view one of three versions of the original FDA–proposed warning labels in a between-subjects experiment: no sponsor, “US Food and Drug Administration,” or “American Cancer Society” sponsor. We tested the effect of varying sponsorship on source attribution and source credibility. Results Compared to unsponsored labels, FDA sponsorship increased source attributions that the FDA sponsored the labels among both middle-school, largely nonsmoking youth and adult smokers. However, sponsorship had no effect on source credibility among either population. Conclusions We found no evidence that adding FDA as the source is likely to boost source credibility judgments, at least in the short term; though doing so would not appear to have adverse effects on credibility judgments. As such, our data are largely consistent with the Tobacco Control Act’s provisions that allow, but do not require, FDA sponsorship on the labels. Implications This study addresses the FDA’s regulatory efforts by informing the possible design and content of future cigarette warning labels. Our results do not offer compelling evidence that adding the FDA name on GWLs will directly increase source credibility. Future work may test more explicit FDA source labeling and continue to examine the credibility of tobacco message content among high–priority populations.

Trajectories of Injectable Cancer Drug Costs After Launch in the United States

2018 ◽  
Vol 36 (4) ◽  
pp. 319-325 ◽  
Author(s):  
Noa Gordon ◽  
Salomon M. Stemmer ◽  
Dan Greenberg ◽  
Daniel A. Goldstein
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
The United States ◽  
Drug Costs ◽  
Cancer Drug ◽  
Steady Increase ◽  
Drug Prices ◽  
The Us ◽  
The Mean ◽  
Over Time

Purpose Cancer drug prices at launch have increased in recent years. It is unclear how individual drug prices change over time after launch and what market determinants influence these changes. We measured the price trajectories of a cohort of cancer drugs after their launch into the US market and assessed the influence of market structure on price changes. Methods We studied the changes in mean monthly costs for a cohort of 24 patented, injectable anticancer drugs that were approved by the US Food and Drug Administration between 1996 and 2012. To account for discounts and rebates, we used the average sales prices published by the Centers for Medicare and Medicaid Services. Costs were adjusted to US general and health-related inflation rates. For each drug, we calculated the cumulative and annual drug cost changes. We then used a multivariable regression model to evaluate the association between market and cost changes over time. Results With a mean follow-up period of 8 years, the mean percent change in cost for all drugs was +25% (range, −14% to +96%). After adjusting for inflation, the mean cost change was +18% (range, −16% to +59%). Rituximab and trastuzumab followed a similar pattern in cost increases over time, and the inflation-adjusted monthly costs rose since approval by 49% and 44%, respectively. New supplemental US Food and Drug Administration approvals, new off-label indications, and new competitors did not influence the annual cost change rates. Conclusion Anticancer drug costs may change substantially after launch. Regardless of competition or supplemental indications, there is a steady increase in costs of patented anticancer agents over time. New regulations may be needed to prevent additional increases in drug costs after launch.

scholarly journals Food and Drug Administration guidances on biosimilars: an update for the gastroenterologist

2018 ◽  
Vol 11 ◽  
pp. 175628481879960 ◽  
Author(s):  
Michael Epstein
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
The United States ◽  
Biologic Therapies ◽  
Tnf Α ◽  
The Us ◽  
Guidance Documents ◽  
Inflammatory Bowel ◽  
Factor Α ◽  
Necrosis Factor

The management of inflammatory bowel disease (IBD), a significant cause of morbidity in the United States (US), has been revolutionized over the last two decades by the introduction of biologic therapies. These include antitumor necrosis factor α (TNF-α) agents. Since 2016, five biosimilar TNF-α inhibitors have been approved by the US Food and Drug Administration (FDA) for use in the treatment of IBD. The FDA has published a series of guidance documents related to the evaluation, licensing, and approval of biosimilars. The aim of this review is to provide an overview of these FDA guidances and the issues associated with biosimilars in the US.

scholarly journals US Food and Drug Administration Approval of Whole Slide Imaging for Primary Diagnosis: A Key Milestone Is Reached and New Questions Are Raised

2018 ◽  
Vol 142 (11) ◽  
pp. 1383-1387 ◽  
Author(s):  
Andrew J. Evans ◽  
Thomas W. Bauer ◽  
Marilyn M. Bui ◽  
Toby C. Cornish ◽  
Helena Duncan ◽  
...  
Keyword(s):  
United States ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Digital Pathology ◽  
The United States ◽  
Primary Diagnosis ◽  
Clinical Applications ◽  
Whole Slide Imaging ◽  
The Us ◽  
Available Information

April 12, 2017 marked a significant day in the evolution of digital pathology in the United States, when the US Food and Drug Administration announced its approval of the Philips IntelliSite Pathology Solution for primary diagnosis in surgical pathology. Although this event is expected to facilitate more widespread adoption of whole slide imaging for clinical applications in the United States, it also raises a number of questions as to the means by which pathologists might choose to incorporate this technology into their clinical practice. This article from the College of American Pathologists Digital Pathology Committee reviews frequently asked questions on this topic and provides answers based on currently available information.

Allegron and aventyl - nortriptyline

1963 ◽  
Vol 1 (15) ◽  
pp. 57-58
Keyword(s):  
United States ◽  
Drug Administration ◽  
Wide Spectrum ◽  
Food And Drug Administration ◽  
The United States ◽  
Methyl Group ◽  
The Us ◽  
Drug Promotion ◽  
Depressant Drug

Nortriptyline, a new anti-depressant drug, has just been launched simultaneously as a “potent multi-phasic psychotrope, highly predictable in action” (Allegron - Dista), and as a “wide spectrum mood enhancer” (Aventyl - Lilly). Connoisseurs of drug promotion will note that Dista is a subsidiary of Lilly. Nortriptyline has not so far been marketed in the United States, where it was discovered; it has not yet been approved by the US Food and Drug Administration. Chemically the drug closely resembles amitriptyline, differing from it by only one methyl group.

scholarly journals Use of Flavored E-Cigarettes and the Type of E-Cigarette Devices Used among Adults and Youth in the US—Results from Wave 3 of the Population Assessment of Tobacco and Health Study (2015–2016)

2019 ◽  
Vol 16 (16) ◽  
pp. 2991 ◽  
Author(s):  
Liane M. Schneller ◽  
Maansi Bansal-Travers ◽  
Maciej L. Goniewicz ◽  
Scott McIntosh ◽  
Deborah Ossip ◽  
...  
Keyword(s):  
United States ◽  
Smoking Cessation ◽  
Drug Administration ◽  
Smoking Status ◽  
Food And Drug Administration ◽  
The United States ◽  
Health Study ◽  
Population Assessment ◽  
The Us

The United States (U.S.) Food and Drug Administration has expressed concern about flavored e-cigarettes (e.g., JUUL brand) because they are appealing to youth who may be unaware that the product is addictive. The Population Assessment of Tobacco and Health Study Wave 3 provided data on flavor categories, type of e-cigarette product, and smoking status among past 30-day youth and adult e-cigarette users in the US. Most past 30-day youth and adult users reported using only one flavor category, with fruit (53% youth, 31% adult) being the most commonly reported category. Adults were far more likely to report using tobacco flavor alone, compared to any other individual flavor category or flavor category combinations (OR: 21.08, 95%CI: 5.92, 75.12). Whereas, youth were more likely to report using multiple flavor categories (OR: 2.03, 95%CI: 1.55, 2.65), with the most reported pairing being fruit and candy (36%). The variety of flavors on the market appeals to consumers of all ages. Although most past 30-day e-cigarette users reported only one flavor category, non-tobacco flavors were far more common among youth. Differences in flavor preferences among adult versus youth vapers may have implications for the role of flavors in both the initiation of youth vaping and adult vaping for smoking cessation.

Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014)

2016 ◽  
Vol 34 (16) ◽  
pp. 1928-1934 ◽  
Author(s):  
Ari Gnanasakthy ◽  
Carla DeMuro ◽  
Marci Clark ◽  
Emily Haydysch ◽  
Esprit Ma ◽  
...  
Keyword(s):  
Drug Administration ◽  
Study Design ◽  
Fast Track ◽  
Food And Drug Administration ◽  
The United States ◽  
Priority Review ◽  
Product Labeling ◽  
End Points ◽  
Patient Reported ◽  
The Us

Purpose To review the use of patient-reported outcome (PRO) data in medical product labeling granted by the US Food and Drug Administration (FDA) for new molecular entities and biologic license applications by the FDA Office of Hematology and Oncology Products (OHOP) between January 2010 and December 2014, to elucidate challenges faced by OHOP for approving PRO labeling, and to understand challenges faced by drug manufacturers to include PRO end points in oncology clinical trials. Methods FDA Drug Approval Reports by Month were reviewed to obtain the number of new molecular entities and biologic license applications approved from 2010 to 2014. Drugs approved by the FDA OHOP during this period were selected for further review, focusing on brand and generic name; approval date; applicant; indication; PRO labeling describing treatment benefit, measures, end point status, and significant results; FDA reviewer feedback on PRO end points; and study design of registration trials. First in class, priority review, fast track, orphan drug, or accelerated approval status was retrieved for selected oncology drugs from 2011 to 2014. Descriptive analyses were performed by using Microsoft Excel 2010. Results Of 160 drugs approved by the FDA (2010-2014), 40 were approved by OHOP. Three (7.5%) of the 40 received PRO-related labeling (abiraterone acetate, ruxolitinib phosphate, and crizotinib). Compared with nononcology drugs (2011-2014), oncology drugs were more likely to be orphan and first in class. The majority of oncology drug reviews by FDA were fast track, priority, or accelerated. Conclusion Although symptoms and functional decrements are common among patients with cancer, PRO labeling is rare in the United States, likely because of logistical hurdles and oncology study design. Recent developments within the FDA OHOP to capture PROs in oncology studies for the purpose of product labeling are encouraging.

scholarly journals Underutilisation of no-tobacco-sale orders against retailers that repeatedly sell to minors, 2015–2019, USA

2021 ◽  
pp. tobaccocontrol-2020-056379
Author(s):  
Natalie Hemmerich ◽  
Desmond Jenson ◽  
Brice L Bowrey ◽  
Joseph G L Lee
Keyword(s):  
Content Analysis ◽  
Tobacco Control ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Smoking Prevention ◽  
Quantitative Content Analysis ◽  
Tobacco Products ◽  
Quantitative Content ◽  
The Family ◽  
The Usa

ImportanceResearch demonstrates that policies aimed at retailers who sell to minors must be strongly enforced to have an impact on youth usage rates.ObjectivesIn the USA, the Food and Drug Administration (FDA) conducts compliance checks, issues fines, and can order retailers to stop selling tobacco products (ie, no-tobacco-sale orders (NTSOs)) to enforce the Family Smoking Prevention and Tobacco Control Act. We sought to assess FDA’s utilisation of NTSOs.MethodsWe conducted a quantitative content analysis of FDA’s enforcement actions for inspections decided between 1 October 2015 and 29 March 2019. From the 536 134 inspection records we identified 148 NTSOs and 249 720 unique retailer locations, of which 2095 had three or more violations. We randomly sampled NTSOs (n=76) and retail locations (n=152) with frequent violations. We calculated the proportion of NTSOs that could have been issued earlier by FDA. We then calculated the proportion of retailers that could have been issued an NTSO, and the proportion actually issued an NTSO using FDA’s approach and a more stringent approach.ResultsAmong NTSOs, 94.7% (95% CI: 89.8% to 97.4%) of NTSOs could have been issued earlier under a more stringent approach. On average, when an NTSO could have been issued earlier, it could have been issued 453 days earlier (95% CI: 418 to 489; range: 89–1159). Among frequently violating retail locations, 73.6% (95% CI: 66.0% to 80.0%) were eligible for an NTSO. Of those, 1.9% (95% CI: 0.5% to 7.0%) had received an NTSO.ConclusionsThe FDA’s failure to fully leverage its powers to address retailers’ underage sales of tobacco products has weakened efforts to curb the youth e-cigarette epidemic.

scholarly journals Low-Calorie Sweetened Beverages and Cardiometabolic Health: A Science Advisory From the American Heart Association

Circulation ◽  
2018 ◽  
Vol 138 (9) ◽  
Author(s):  
Rachel K. Johnson ◽  
Alice H. Lichtenstein ◽  
Cheryl A.M. Anderson ◽  
Jo Ann Carson ◽  
Jean-Pierre Després ◽  
...  
Keyword(s):  
United States ◽  
Drug Administration ◽  
High Intensity ◽  
Food And Drug Administration ◽  
The United States ◽  
Cardiometabolic Health ◽  
Low Calorie ◽  
Writing Group ◽  
Sweetened Beverages ◽  
The Us

In the United States, 32% of beverages consumed by adults and 19% of beverages consumed by children in 2007 to 2010 contained low-calorie sweeteners (LCSs). Among all foods and beverages containing LCSs, beverages represent the largest proportion of LCS consumption worldwide. The term LCS includes the 6 high-intensity sweeteners currently approved by the US Food and Drug Administration and 2 additional high-intensity sweeteners for which the US Food and Drug Administration has issued no objection letters. Because of a lack of data on specific LCSs, this advisory does not distinguish among these LCSs. Furthermore, the advisory does not address foods sweetened with LCSs. This advisory reviews evidence from observational studies and clinical trials assessing the cardiometabolic outcomes of LCS beverages. It summarizes the positions of government agencies and other health organizations on LCS beverages and identifies research needs on the effects of LCS beverages on energy balance and cardiometabolic health. The use of LCS beverages may be an effective strategy to help control energy intake and promote weight loss. Nonetheless, there is a dearth of evidence on the potential adverse effects of LCS beverages relative to potential benefits. On the basis of the available evidence, the writing group concluded that, at this time, it is prudent to advise against prolonged consumption of LCS beverages by children. (Although water is the optimal beverage choice, children with diabetes mellitus who consume a balanced diet and closely monitor their blood glucose may be able to prevent excessive glucose excursions by substituting LCS beverages for sugar-sweetened beverages [SSBs] when needed.) For adults who are habitually high consumers of SSBs, the writing group concluded that LCS beverages may be a useful replacement strategy to reduce intake of SSBs. This approach may be particularly helpful for persons who are habituated to a sweet-tasting beverage and for whom water, at least initially, is an undesirable option. Encouragingly, self-reported consumption of both SSBs and LCS beverages has been declining in the United States, suggesting that it is feasible to reduce SSB intake without necessarily substituting LCS beverages for SSBs. Thus, the use of other alternatives to SSBs, with a focus on water (plain, carbonated, and unsweetened flavored), should be encouraged.

scholarly journals Zohydro™ Approval by Food and Drug Administration: Controversial or Frightening?

2014 ◽  
Vol 4;17 (4;7) ◽  
pp. E437-E450 ◽  
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Drug Administration ◽  
Addiction Treatment ◽  
Motor Vehicle ◽  
Food And Drug Administration ◽  
Opioid Analgesics ◽  
The United States ◽  
Opioid Addiction ◽  
Advisory Panel ◽  
Medical Necessity ◽  
The Us

The actions and regulations of the Food and Drug Administration (FDA) are crucial to the entire population of the US, specifically the public who take a multitude of drugs and providers who prescribe drugs and devices. Further, the FDA is relevant to investors, specifically in regards to biotech and pharmaceutical companies involved in developing new drugs. The FDA has been criticized for a lack of independence on the one hand and excessive regulatory and expanding authority without evidence and consistency of the actions on the other hand. The FDA approved a single-entity, long-acting, hydrocodone product (Zohydro™, Zogenix, San Diego, CA) on October 25, 2013, against the recommendation of the FDA’s own appointed scientific advisory panel, which voted 11 to 2 against the approval of Zohydro. Subsequent to the approval, multiple consumer safety organizations, health care agencies, addiction treatment providers, professional organizations, and other groups on the frontline of the opioid addiction epidemic have expressed concern. In addition, the US Congress and various state attorneys general raised serious concerns about the approval of Zohydro, which is highly addictive and may enhance the opioid addiction epidemic. Supporters of Zohydro contend that it is necessary and essential to manage chronic pain and improve functional status with no additional risk. Over the past 15 years, prescriptions for opioids have skyrocketed with the United States consuming more than 84% of the global oxycodone and more than 99% of the hydrocodone supply. The sharp increase in opioid prescribing has led to parallel increases in opioid addiction and overdose deaths, surpassing motor vehicle injuries in the US. Recent studies assessing the trends of medical use and misuse of opioid analgesics from 2000 to 2011 have concluded that the present trend of the continued increase in the medical use of opioid analgesics appears to contribute to increasing misuse, resulting in multiple health consequences, despite numerous regulations enforced by multiple organizations. The approval of Zohydro and its defense from the FDA were based on a misunderstanding of the prevalence of chronic severe disabling pain. Based on inaccurate data from the Institute of Medicine, in part caused by conflicts of interest, 100 million persons have been described to suffer from severe pain -- the correct number is 22.6 million. This manuscript analyzes 3 important principles of drug approval and utilization based on safety, efficacy, and medical necessity. Based on the limited literature that the authors were able to review including that which was submitted to the FDA by the manufacturers, it appears the safety, efficacy, and medical necessity were not demonstrated. In fact, the study submitted to the FDA showed a 50% pain improvement in only 48% of the patients in the treatment group and 21% of the patients in the placebo group at 85 day follow-up. This is a statistically significant result but its clinical relevance is unknown. The FDA approval decision occurring against the backdrop of the advisory panel recommendation is concerning and may result in serious consequences in the future. Key words: Chronic non-cancer pain, Food and Drug Administration, opioids, Zohydro, misuse, tolerance, addiction, dependency, medical necessity

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