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 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.

The Signaling Effects of the US Food and Drug Administration Fast-Track Designation

2016 ◽  
Vol 38 (4) ◽  
pp. 581-594 ◽  
Author(s):  
Kathleen L. Miller ◽  
Clark Nardinelli ◽  
George Pink ◽  
Kristin Reiter
Keyword(s):  
Drug Administration ◽  
Fast Track ◽  
Food And Drug Administration ◽  
The Us ◽  
Fast Track Designation

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 FDA Regulatory Perspectives for Studies on Hemodialysis Vascular Access

2017 ◽  
Vol 13 (3) ◽  
pp. 513-518 ◽  
Author(s):  
Frank P. Hurst ◽  
Robert E. Lee ◽  
Aliza M. Thompson ◽  
Brian D. Pullin ◽  
Douglas M. Silverstein
Keyword(s):  
New Product Development ◽  
Drug Administration ◽  
Vascular Access ◽  
Food And Drug Administration ◽  
Product Evaluation ◽  
End Points ◽  
Health Initiative ◽  
Hemodialysis Vascular Access ◽  
The Us ◽  
Kidney Health

In an effort to foster innovation and new product development, the American Society of Nephrology and the US Food and Drug Administration partnered to form the Kidney Health Initiative in 2012. Part of the Kidney Health Initiative’s mission is to foster development of therapies by creating a collaborative environment where the US Food and Drug Administration and the greater nephrology community can interact to optimize product evaluation. This particular Kidney Health Initiative project focused on products related to hemodialysis vascular access, with the goal of clarifying appropriate trial end points that could subsequently inform clinical, regulatory, and coverage decisions. Both the lack of common definitions and the lack of consensus on trial end points have been viewed as barriers to innovation in this area. Toward this end, the Kidney Health Initiative convened teams of expert stakeholders to address these issues for each major vascular access category (arteriovenous grafts, arteriovenous fistulas, and central venous catheters), and each team provided recommendations. This commentary provides an overview of the US Food and Drug Administration centers that regulate hemodialysis vascular access and certain laws and regulations that affect these products as well as our perspectives on some of the issues raised and end points proposed by the Kidney Health Initiative teams. The standardized definitions and clinical trial end points proposed by the teams represent an important step forward to improve innovation in this area.

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