scholarly journals U.S. Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018

2020 ◽  
Author(s):  
Joshua J. Skydel ◽  
Audrey D. Zhang ◽  
Sanket S. Dhruva ◽  
Joseph S. Ross ◽  
Joshua D. Wallach
Keyword(s):  
Drug Administration ◽  
Clinical Studies ◽  
Food And Drug Administration ◽  
Median Number ◽  
Cross Sectional Study ◽  
New Drugs ◽  
Cross Sectional ◽  
Safety And Efficacy ◽  
Fda Approval ◽  
Therapeutic Safety

Background/Aims: The U.S. Food and Drug Administration (FDA) outlines clinical studies as postmarketing requirements and commitments to be fulfilled following FDA approval of new drugs and biologics ("therapeutics"). As regulators have increasingly emphasized lifecycle evaluation of approved therapeutics, postmarketing studies are intended to advance our understanding of therapeutic safety and efficacy, yet little is known about how often clinical studies are outlined or the indications they investigate. To assess FDA's use of postmarket clinical studies to generate evidence of therapeutic safety and efficacy, we characterized FDA postmarketing requirements and commitments for new therapeutics approved from 2009-2018. Methods: We conducted a cross-sectional study of all novel therapeutics, including small molecule drugs and biologics, receiving original FDA approval from 2009-2018, using approval letters accessed through the Drug@FDA database. Outcomes included the number and characteristics of FDA postmarketing requirements and commitments for new therapeutics at original approval, including types of studies outlined, indications to be investigated, and clinical evidence to be generated. Results: From 2009-2018, FDA approved 343 new therapeutics with 1978 postmarketing requirements and commitments. Overall, 750 (37.9%) postmarketing requirements and commitments outlined clinical studies. For 71 of 343 (20.7%) therapeutics, no postmarketing requirements nor commitments for clinical studies were outlined, while at least 1 was outlined for 272 (79.3%; median = 2 (IQR, 1-4)). Among these 272 therapeutics, the number of postmarketing requirements and commitments for clinical studies per therapeutic did not significantly change from 2009 (median 2 (IQR, 1-4)) to 2018 (median 2 (IQR, 1-3); P = .54). Among the 750 postmarketing requirements and commitments for clinical studies, 448 (59.7%) outlined new prospective cohort studies, registries, or clinical trials, while the remainder outlined retrospective studies, secondary analyses, or completion of ongoing studies. Although 455 (60.7%) clinical studies investigated only original approved therapeutic indications, 123 (16.4%) enrolled from an expansion of the approved disease population and 61 (8.1%) investigated diseases unrelated to approved indications. Conclusions: Most therapeutics are approved by FDA with at least 1 postmarketing requirement or commitment for a clinical study, which outline investigations of safety or efficacy for both approved and unapproved indications. However, the median number of 2 clinical studies outlined has remained relatively constant over the last decade, despite increasing emphasis on lifecycle evaluation of approved therapeutics.

scholarly journals US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018

2021 ◽  
pp. 174077452110050
Author(s):  
Joshua J Skydel ◽  
Audrey D Zhang ◽  
Sanket S Dhruva ◽  
Joseph S Ross ◽  
Joshua D Wallach
Keyword(s):  
Drug Administration ◽  
Clinical Studies ◽  
Clinical Evidence ◽  
Food And Drug Administration ◽  
Median Number ◽  
Cross Sectional Study ◽  
Interquartile Range ◽  
New Drugs ◽  
Cross Sectional ◽  
The Us

Background/Aims The US Food and Drug Administration outlines clinical studies as postmarketing requirements and commitments to be fulfilled following approval of new drugs and biologics (“therapeutics”). Regulators have increasingly emphasized lifecycle evaluation of approved therapeutics, and postmarketing studies are intended to advance our understanding of therapeutic safety and efficacy. However, little is known about the indications that clinical studies outlined in postmarketing requirements and commitments investigate, including whether they are intended to generate evidence for approved or other clinical indications. Therefore, we characterized US Food and Drug Administration postmarketing requirements and commitments for new therapeutics approved from 2009 to 2018. Methods We conducted a cross-sectional study of all novel therapeutics, including small-molecule drugs and biologics, receiving original US Food and Drug Administration approval from 2009 to 2018, using approval letters accessed through the Drug@FDA database. Outcomes included the number and characteristics of US Food and Drug Administration postmarketing requirements and commitments for new therapeutics at original approval, including the types of studies outlined, the indications to be investigated, and the clinical evidence to be generated. Results From 2009 to 2018, the US Food and Drug Administration approved 343 new therapeutics with 1978 postmarketing requirements and commitments. Overall, 750 (37.9%) postmarketing requirements and commitments outlined clinical studies. For 71 of 343 (20.7%) therapeutics, no postmarketing requirements or commitments for clinical studies were outlined, while at least 1 was outlined for 272 (79.3%; median 2 (interquartile range: 1–4)). Among these 272 therapeutics, the number of postmarketing requirements and commitments for clinical studies per therapeutic did not change from 2009 (median: 2 (interquartile range: 1–4)) to 2018 (median: 2 (interquartile range: 1–3)). Among the 750 postmarketing requirements and commitments for clinical studies, 448 (59.7%) outlined new prospective cohort studies, registries, or clinical trials, while the remainder outlined retrospective studies, secondary analyses, or completion of ongoing studies. Although 455 (60.7%) clinical studies investigated only original approved therapeutic indications, 123 (16.4%) enrolled from an expansion of the approved disease population and 61 (8.1%) investigated diseases unrelated to approved indications. Conclusions The US Food and Drug Administration approves most new therapeutics with at least 1 postmarketing requirement or commitment for a clinical study, and outlines investigations of safety or efficacy for both approved and unapproved indications. The median number of 2 clinical studies outlined has remained relatively constant over the last decade. Given increasing emphasis by the US Food and Drug Administration on faster approval and lifecycle evaluation of therapeutics, these findings suggest that more postmarketing requirements and commitments may be necessary to address gaps in the clinical evidence available for therapeutics at approval.

Biosimilar epoetin for cancer and chemotherapy-induced anaemia in the US

2021 ◽  
Vol 10 (3) ◽  
pp. 122-122
Author(s):  
Charles L Bennett
Keyword(s):  
Advisory Committee ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Pharmacokinetics And Pharmacodynamics ◽  
Safety And Efficacy ◽  
Biological Drug ◽  
Drug Products ◽  
Fda Approval ◽  
The Us ◽  
Approval Letter

Biosimilars are biological drug products that are highly similar to reference products in analytic features, pharmacokinetics and pharmacodynamics, immunogenicity, safety and efficacy. Biosimilar epoetin received US Food and Drug Administration (FDA) approval in 2018 [1]. The manufacturer received an FDA non-approval letter in 2017, despite receiving a favourable review by the FDA’s Oncologic Drugs Advisory Committee (ODAC) and an FDA non-approval letter in 2015 for an earlier formulation.

scholarly journals Do drug package inserts meet the rules and regulations of Iran’s Food and Drug Administration in terms of informing patients?

2019 ◽  
Vol 9 (3) ◽  
pp. 214-222
Author(s):  
Tahereh Eteraf-Oskouei ◽  
Saeid Abdollahpour ◽  
Moslem Najafi ◽  
Vahideh Zarea Gavgani
Keyword(s):  
Drug Administration ◽  
Mobile Apps ◽  
Food And Drug Administration ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Microsoft Excel ◽  
Cross Sectional ◽  
Reference Category ◽  
Package Inserts ◽  
Source Of Information

Background: Drug package inserts (PIs) are the most accessible source of information for users and are designed to aid the safe use of medicines and avert adverse events. This study measured the conformity of PIs with the health communications standards of Iran’s Food and Drug Administration (FDA). Methods: This descriptive cross-sectional study evaluated 92 PIs related to 22 best-selling neurological and psychiatric drugs in Iran based on criteria approved by Iran’s FDA. Six categories of criteria were considered in evaluating the extent of conformity: I) writing and formatting, II) references, III) drug description, IV) warnings and precautions, V) interactions, and VI) side effects. Each PI was scored based on observation of standards; data was analyzed using Microsoft Excel pivot tables. Results: In total, 2929 items from 92 PIs were evaluated, of which 37 (40.2%) were related to antidepressants, 31 (33.7%) to sedatives and hypnotics, and 24 (26%) to anticonvulsant drugs. The PI content was insufficient in various aspects of conformity with standards in each category. Among the six categories, the best match was found in warnings and precautions with 667 items (72.5%), followed by writing and formatting with 663 (69.1%). The lowest conformity was found in the reference category with 194 (26.4%) items. Conclusion: The PIs of Iranian neurological drugs do not fully meet Iran’s FDA standards. It is strongly recommended that smart PIs be developed using mobile apps to overcome this problem.

scholarly journals Perceived Implications of Current Conflict of Interest Policy in Individuals Accepted or Rejected for Participation in Food and Drug Administration Advisory Committee

2020 ◽  
Author(s):  
Yuichi J. Shimada ◽  
Kyle Hair ◽  
Adrienne Faerber ◽  
Christian G. Zimmerman ◽  
Timothy Houchin ◽  
...  
Keyword(s):  
Drug Administration ◽  
Online Survey ◽  
Conflicts Of Interest ◽  
Present Report ◽  
Food And Drug Administration ◽  
Cross Sectional Study ◽  
Advisory Committees ◽  
Cross Sectional ◽  
Interest Policy

ABSTRACTBackground and ObjectiveThe Food and Drug Administration (FDA) relies on advice from scientific and medical experts to make approval decisions about new prescription medications and medical devices. Therefore, it is crucial that FDA Advisory Committees (ACs) include the most knowledgeable scientists and clinicians in the decision-making process. However, to ensure that the advice is free from biases, current FDA policy often excludes those most qualified from participating in ACs due to perceived conflicts of interest (COI). The objective of the present study is to elicit opinion among subject matter experts regarding current FDA COI rules and regulations.MethodsWe conducted a cross-sectional study using formal, self-administered online survey consisting of 14 questions, 3 of which addressed perceived implications of current FDA COI policy. We send a formal online survey to study subjects via Qualtrics. Study subjects were 1) individuals who participated in FDA ACs and 2) those who were interested in participating in ACs and had completed FDA COI paperwork but rejected by the FDA due to COI. The outcome measure is response to the 3 questions about the perceived implications of current FDA COI policy. Responses were scored on a 5-point Likert-type scale.ResultsAmong 403 study subjects (200 AC members and 203 individuals who were rejected due to COI), 145 (36%) responded to the survey including 90 AC members and 55 rejected individuals. Respondents included 41 (28%) females. 97% were holding MD or PhD degrees. 88% were age 46 and over, and 66% had more than 25 years in practice. The primary findings were that 49% of respondents agreed that the current FDA regulations lead to a lower quality of experts on ACs, 72% agreed that current policies exclude qualified experts from serving on ACs, and 48% agreed that FDA policy lowers the overall quality of AC input, to at least a “moderate” extent (19%-37% to a “high” or “very high” extent).ConclusionsThe prevailing opinion among respondents to the formal survey is that current FDA COI policy has the potential effects to lowering quality of experts, excluding qualified experts, and lowering overall quality of AC input. The present report elucidates a potential need for the FDA to discuss the benefit and risk of the current AC COI policies.

Highlights on the Labels of Packaged Foods Sold in Jordanian Market from A Cross-Sectional Study

2021 ◽  
Vol 9 (3) ◽  
pp. 770-782
Author(s):  
Narmeen J. Al-Awwad ◽  
Hiba F. Al-Sayyed ◽  
Hamzah Safi ◽  
Salma M. Al-Bosta ◽  
Summer Al-Zawawi
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Cross Sectional Study ◽  
Food Labels ◽  
Trans Fat ◽  
Food Label ◽  
Sectional Study ◽  
Cross Sectional ◽  
Added Sugars ◽  
Packaged Foods

Jordan has adapted a strategy to prevent chronic diseases. Accordingly, Ministry of Health is looking for controlling food labeling particularly food fat, trans-fat, and caloric content. This study aimed to screen the food label of products that are sold in Jordanian market in terms of serving size, energy, macronutrient, fiber, total and added sugars, saturated and trans fat, cholesterol, dietary fiber, and micronutrient contents. A cross-sectional study was performed to screen the food label for the food products based on the standards of The United States Food and Drug Administration (FDA) regulations of 2016 and Jordan Food and Drug Administration (JFDA). Generally, food labels were not clear. The screened products were compliant with JFDA standards and not in compliance with some FDA standards. In addition, many products were found to be sources of added sugars, Na, and saturated fats. Stakeholders and legislators are called to focus on developing new laws, regulations, and polices for developing food label. Food manufacturers are needed to work hardly on developing informative, clear, easy-to-understand, and attractive food labels. The legislators of food label policies are called to look for ways to indicate the presence of high amounts of dietary risk factors such as sugars, added sugars, Na, saturated, and trans fats in packaged foods.

scholarly journals Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis

BMJ ◽  
2018 ◽  
pp. k2031 ◽  
Author(s):  
Joshua D Wallach ◽  
Alexander C Egilman ◽  
Sanket S Dhruva ◽  
Margaret E McCarthy ◽  
Jennifer E Miller ◽  
...  
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
New Drugs ◽  
Cross Sectional ◽  
Cross Sectional Analysis ◽  
The Us ◽  
Sectional Analysis

scholarly journals Investigating the Food and Drug Administration (FDA) Biotherapeutics Review and Approval Process: A Scoping Review (Preprint)

2019 ◽  
Author(s):  
Farzan Sasangohar ◽  
Samuel Bonet Olivencia
Keyword(s):  
Drug Administration ◽  
Systems Engineering ◽  
Scoping Review ◽  
Food And Drug Administration ◽  
The United States ◽  
New Drugs ◽  
Approval Process ◽  
Biological Products ◽  
Sociotechnical System ◽  
Fda Approval

BACKGROUND The development, review and approval process of therapeutic biological products in the United States presents two primary challenges: time and cost. Advancing a biotherapeutic from concept to market may take an average of twelve years with costs exceeding one billion dollars. Even after significant time and resources have been invested in a therapy, the product may still fail the U.S. Food and Drug Administration (FDA) approval process. A subset of advocacy groups and experts in drug regulations and policies are demanding a more rapid approval and release of bio-products. Despite the FDA’s practices to expedite the approval of new therapies, seeking FDA approval remains a long, costly, and risky process. OBJECTIVE The objective of this paper is to explore the factors and gaps related to the FDA review and approval process which contribute to process inefficiencies and complexities, as well as proposed methods and solutions to address such gaps. This paper aims to investigate the available modeling efforts for the FDA approval process of therapeutic biological products. METHODS A scoping review of the literature was conducted to understand the scope of published peer-reviewed knowledge about challenges, opportunities, and specific methods to address these factors and gaps related to the review and approval of new drugs, including therapeutic biological products. Relevant peer-reviewed journal articles, conference proceedings, official reports from public policy professional centers, and official reports and guidelines from the FDA were reviewed. RESULTS To the best of our knowledge, none of the articles identified in this scoping literature review have modeled the current FDA review and approval process structure to address issues related to the robustness, reliability, and efficiency of its operations from an external point of view. While several studies summarize the FDA approval process with clarity, in addition to bringing to light the problems and challenges that the regulatory agency is facing, only a few attempts to provide solutions for the problems and challenges identified. In addition, while several reform models were discussed, broadly stated, these models lack the application of scientific methodologies and modeling techniques in understanding FDA as a complex sociotechnical system. Furthermore, tools and methods to assess the models’ efficacy before implementation are largely absent. CONCLUSIONS Findings suggest the efficacy of Model-Based Systems Engineering (MBSE) approaches for identifying opportunities for significant improvements to the FDA review and approval process. Using this holistic approach will serve several investigative purposes: (1) identify influential sources of variability that cause major delays including individual, team, and organizational decision-making, (2) identify the human-system bottlenecks, (3) identify areas of opportunity for design-driven improvements, (4) study the effect of induced changes in the system, and (5) assess the robustness of the structure of the FDA approval process in terms of enforcement and information symmetry.

scholarly journals Recognition of tramadol abuse, dispensing practices, and opinions about its control policy among community pharmacists in Bangkok, Thailand

2019 ◽  
Vol 12 (2) ◽  
pp. 91-99
Author(s):  
Tulaya Potaros ◽  
Suwimon Yeephu
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Community Pharmacists ◽  
Control Policy ◽  
Cross Sectional Study ◽  
Community Pharmacies ◽  
Sectional Study ◽  
Cross Sectional ◽  
Dispensing Practices ◽  
Different Parts

AbstractBackgroundTramadol is classified as a pharmacist-only (restricted) medicine by the Food and Drug Administration of Thailand (Thai FDA). Because of concern about its abuse, in September 2013 the Thai FDA announced a policy to control the distribution of tramadol in community pharmacies.ObjectivesTo identify tramadol dispensing practices by community pharmacists in Bangkok, their recognition of tramadol abuse and the Thai FDA control policy announcement; and opinions about the tramadol control policy.MethodsThis descriptive cross-sectional study was conducted in community pharmacies located in Bangkok. Pharmacists on duty were interviewed from September 2015 to April 2016.ResultsData from 305 pharmacists working in 305 pharmacies revealed that tramadol, both single (tramadol alone) and combination (tramadol plus acetaminophen) formulations, was available in 185 pharmacies (60.7%). Most pharmacists dispensed tramadol to supply regular medicine along with previous prescriptions (74%). Among 305 pharmacists, 304 (99.7%) recognized tramadol abuse in combination with cold–cough remedies and carbonated beverages can create euphoria. Most (97.7%) knew about the announcement of the tramadol control policy, and most (82.6%) thought that the policy was practical. Approximately 43% of pharmacists agreed that the policy was effective in reducing the tramadol abuse problem, whereas 36.7% disagreed. Moreover, 60.3% disagreed with rescheduling tramadol as a prescription-only medicine. In their opinion, tramadol should still be available in pharmacies, to be dispensed by community pharmacists to patients with medical necessity.ConclusionsFurther studies nationwide in Thailand are likely to be useful to represent and compare information in different parts of the country.

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