Abuse-deterrent formulations approval reform: Will clinical correctness or real-world results be used to address the nation's opioid crisis: “Noninterference” as a new approval standard

2017 ◽  
Vol 13 (6) ◽  
pp. 357
Author(s):  
Dan Cohen, MA/LS
Keyword(s):  
Public Policy ◽  
Drug Administration ◽  
Real World ◽  
Food And Drug Administration ◽  
Innovative Technologies ◽  
The Public ◽  
Opioid Crisis ◽  
Policy Objectives ◽  
Effective Role ◽  
The U.S

To further the public policy objectives of Congress and the country, legislators should now insist that abuse-deterrent formulations (ADFs) be deployed for every C-II opioid and stimulant. The need for these innovative technologies has never been greater. And to most efficiently incentivize innovators to develop and deploy the most effective and modern deterrents, a new and simpler regulatory approval standard for ADF should be adopted by the U.S. Food and Drug Administration. That standard, based on a concept of “Noninterference” increases the potential for a much earlier deployment of ADFs in a broad range of products and allows deterrence to play its most effective role in combatting the national opioid crisis.

Transparency at the U.S. Food and Drug Administration

2017 ◽  
Vol 45 (S2) ◽  
pp. 24-28
Author(s):  
Robert M. Califf
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Study Data ◽  
Critical Examination ◽  
Misleading Information ◽  
The Public ◽  
The Public Sphere ◽  
Innovation Knowledge ◽  
Medical Products Industry ◽  
The U.S

Given the profound public health and economic ramifications of decisions made by the U.S. Food and Drug Administration, the degree to which FDA activities should reflect an approach founded on complete transparency versus one focused on preserving confidentiality of information deserves public discussion. On one hand, reasonable requirements for transparency are critical to stimulating effective innovation, knowledge dissemination, and good business practice. On the other, ensuring the vitality of the medical products industry requires protecting legitimately proprietary information. With current standards reflecting a lengthy accumulation of legal, regulatory, and practical precedent, recent significant changes in the environment in which the FDA operates should prompt a critical examination of current practices. In this article, I comment on Sharfstein and colleagues’ “Blueprint for Transparency,” which calls for multiple specific actions to increase transparency at the agency across five key areas, including interactions between FDA and industry, public disclosure of internal FDA analyses, deliberations concerning generics and biosimilars, expanded access to raw study data, and approaches to countering misleading information in the public sphere. I evaluate these recommendations in light of my experience as a clinician, researcher, and former FDA Commissioner, and reflect on possible outcomes that could result from enacting these practices.

Experimental Test of the Educational Impact of the Newly Proposed FDA Graphic Cigarette Warnings Among U.S. Adults

2020 ◽  
Author(s):  
Renee E Magnan ◽  
W Kyle Hamilton ◽  
Bethany Shorey-Fennell ◽  
Linda D Cameron
Keyword(s):  
Drug Administration ◽  
Experimental Test ◽  
Food And Drug Administration ◽  
Electronic Cigarette ◽  
Educational Impact ◽  
The Public ◽  
New Knowledge ◽  
Within Subjects ◽  
Internet Platform ◽  
The U.S

Abstract Background In August 2019, the U.S. Food and Drug Administration proposed a set of 13 new graphic warnings for cigarette packaging and advertisements. Purpose We evaluated these warnings relative to text-only equivalents for their ability to educate the public regarding harms of smoking and influence outcomes associated with quitting. Methods In an experimental within-subjects design, U.S. adult nonsmokers, smokers, and dual smoker/electronic cigarette (e-cigarette) users (N = 412) recruited from an online internet platform evaluated the newly proposed graphic warnings and corresponding text-only warnings on understandability, perceived new knowledge, worry elicited about the content of the warning, discouragement from smoking, and encouragement to use e-cigarettes. Results Graphic warnings were generally rated as providing better understanding, more new knowledge, eliciting more worry about harms of smoking, and providing more discouragement from smoking relative to text-only warnings. Conclusions The newly proposed graphic warnings could influence important responses to warnings associated with motivation to reduce smoking.

Blueprint for Transparency at the U.S. Food and Drug Administration: Recommendations to Advance the Development of Safe and Effective Medical Products

2017 ◽  
Vol 45 (S2) ◽  
pp. 7-23 ◽  
Author(s):  
Joshua M. Sharfstein ◽  
James Dabney Miller ◽  
Anna L. Davis ◽  
Joseph S. Ross ◽  
Margaret E. McCarthy ◽  
...  
Keyword(s):  
Medical School ◽  
Drug Administration ◽  
Task Force ◽  
Food And Drug Administration ◽  
Law School ◽  
The Public ◽  
Medical Products ◽  
Regulatory Processes ◽  
Academic Faculty ◽  
The U.S

BackgroundThe U.S. Food and Drug Administration (FDA) traditionally has kept confidential significant amounts of information relevant to the approval or non-approval of specific drugs, devices, and biologics and about the regulatory status of such medical products in FDA’s pipeline.ObjectiveTo develop practical recommendations for FDA to improve its transparency to the public that FDA could implement by rulemaking or other regulatory processes without further congressional authorization. These recommendations would build on the work of FDA’s Transparency Task Force in 2010.MethodsIn 2016-2017, we convened a team of academic faculty from Harvard Medical School, Brigham and Women’s Hospital, Yale Medical School, Yale Law School, and Johns Hopkins Bloomberg School of Public Health to develop recommendations through an iterative process of reviewing FDA’s practices, considering the legal and policy constraints on FDA in expanding transparency, and obtaining insights from independent observers of FDA.ResultsThe team developed 18 specific recommendations for improving FDA’s transparency to the public. FDA could adopt all these recommendations without further congressional action.FundingThe development of the Blueprint for Transparency at the U.S. Food and Drug Administration was funded by the Laura and John Arnold Foundation.

HIV

2018 ◽  
Author(s):  
Joshua M. Sharfstein
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Research Process ◽  
National Institutes Of Health ◽  
Health Agencies ◽  
Act Up ◽  
The U.S

The emergence of AIDS in the early 1980s caused a profound crisis for federal health agencies, particularly the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). Activists in ACT UP, charging that these agencies were failing patients with AIDS, initiated a series of escalating protests. NIH officials, led by Dr. Anthony Fauci, began to talk with the advocates and make major changes in the research process. However, over at the FDA, a protest involving the arrest of hundreds of AIDS activists undermined the agency’s public health image. Eventually, under a new commissioner, the FDA earned back the trust of activists.

scholarly journals Agenda-setting and Public Policy in Private Foundations

2020 ◽  
Vol 11 (1) ◽  
Author(s):  
Alexandra Kate Williamson ◽  
Belinda Luke
Keyword(s):  
Public Policy ◽  
Agenda Setting ◽  
Public Communication ◽  
Philanthropic Foundations ◽  
Policy Influence ◽  
The Public ◽  
Private Foundations ◽  
Social Causes ◽  
The U.S

AbstractThis paper examines advocacy, agenda-setting and the public policy focus of private philanthropic foundations in Australia. While concerns have been raised regarding advocacy and public policy influence of foundations in countries such as the U.S., less is understood on this issue in other contexts. Interviews were conducted with 11 managers and trustees of 10 Private Ancillary Funds (PAFs) in late 2014. Analysis of publicly available data on the participating PAFs was then undertaken comparing PAF information available at the time of the interviews with that available approximately five years later, to consider any changes in the public communication of their agendas. Findings reveal PAFs’ agendas were largely consistent with public policy but may vary in the approaches to address social causes. Further, a preference for privacy indicates the PAF sector may be characterised as ‘quiet philanthropy’ rather than having a visible public presence. As such, PAFs’ advocacy focused on promoting philanthropy, rather than altering or influencing public policy. Our main contention is that the conceptions of advocacy in structured philanthropy are dominated by the obvious, the outliers and the noisy. Our contribution to the philanthropic literature is a more nuanced and broader discussion of how advocacy and agenda-setting occurs and is understood in the mainstream.

The U.S. Food and Drug Administration’s Complex Innovative Trial Design Pilot Meeting Program: Progress to date

2021 ◽  
pp. 174077452110505
Author(s):  
Dionne Price ◽  
John Scott
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Trial Design ◽  
Drug Evaluation ◽  
Food And Drug Administration ◽  
Medical Product ◽  
Global Public Health ◽  
Multiple Sources ◽  
Meeting Program ◽  
The U.S

Background The Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration have been leaders in advancing science to protect and promote public health by ensuring that safe and effective drugs and biological products are available to those who need them. Recently, new therapeutic discoveries, increased understanding of disease mechanisms, the need for innovation to optimally use resources, and global public health crises have led to an evolving drug development landscape. As a result, the U.S. Food and Drug Administration and medical product developers are faced with unique challenges and opportunities. The U.S. Food and Drug Administration is proactively meeting the challenges of this evolving landscape through various efforts, including the Complex Innovative Trial Design Pilot Meeting Program. Our focus, here, will be on the pilot meeting program. Methods The U.S. Food and Drug Administration has defined a process to facilitate the implementation of the Complex Innovative Trial Design Pilot Meeting Program. The process is transparent and outlines the steps and timeline for submission, review, and meetings. Results Five submitted meeting requests have been selected for participation in the Complex Innovative Trial Design Pilot Meeting Program. Conclusion The pilot meeting program has been successful in further educating stakeholders on the potential uses of complex innovative designs in trials intended to provide substantial evidence of effectiveness. The selected submissions, thus far, have all utilized a Bayesian framework. The reasons for the use of Bayesian approaches may be due to the flexibility provided, the ability to incorporate multiple sources of evidence, and a desire to better understand the U.S. Food and Drug Administration perspective on such approaches. We are confident the pilot meeting program will have continued success and impact the collective goal of bringing safe and effective medical products to patients.

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