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Journal Article

Life Cycle of Medical Product Rules Issued by the US Food and Drug Administration

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Thomas J. Hwang, Jerry Avorn, Aaron S. Kesselheim
J Health Polit Policy Law (2014) 39 (4): 751–780.
DOI: https://doi.org/10.1215/03616878-2743027
Published: 01 August 2014
...Thomas J. Hwang; Jerry Avorn; Aaron S. Kesselheim Abstract The US Food and Drug Administration (FDA) uses rulemaking as one of its primary tools to protect the public health and implement laws enacted by Congress and the president. Because of the many effects that these rules have on social welfare...
FIGURES
View articletitled, Life Cycle of Medical Product Rules Issued by the US <span class="search-highlight">Food</span> and <span class="search-highlight">Drug</span> <span class="search-highlight">Administration</span> View PDF for article titled, Life Cycle of Medical Product Rules Issued by the US <span class="search-highlight">Food</span> and <span class="search-highlight">Drug</span> <span class="search-highlight">Administration</span>
Journal Article

Managing Delegation in the Fda: Reducing Delay in New-Drug Review

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Mary K. Olson
J Health Polit Policy Law (2004) 29 (3): 397–430.
DOI: https://doi.org/10.1215/03616878-29-3-397
Published: 01 June 2004
...Mary K. Olson This article examines the effects of the user fee reform on the speed of drug review in the U.S. Food and Drug Administration. The results show that even after controlling for increased agency resources, the reform reduced review times among new-drug approvals by 34 percent (95...
View articletitled, Managing Delegation in the Fda: Reducing Delay in New-<span class="search-highlight">Drug</span> Review View PDF for article titled, Managing Delegation in the Fda: Reducing Delay in New-<span class="search-highlight">Drug</span> Review
Journal Article

Trends in the Quality of Evidence Supporting FDA Drug Approvals: Results from a Literature Review

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Beatrice L. Brown, Mayookha Mitra-Majumdar, Krysten Joyce, Murray Ross, Catherine Pham ...
J Health Polit Policy Law (2022) 47 (6): 649–672.
DOI: https://doi.org/10.1215/03616878-10041093
Published: 01 December 2022
... of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review .” JAMA Oncology 4 , no. 6 : 849 – 56 . https://doi.org/10.1001/jamaoncol.2017.5618 . Chen Emerson Y. , Haslam Alyson , and Prasad Vinay . 2020 . “ FDA...
FIGURES
View articletitled, Trends in the Quality of Evidence Supporting FDA <span class="search-highlight">Drug</span> Approvals: Results from a Literature Review View PDF for article titled, Trends in the Quality of Evidence Supporting FDA <span class="search-highlight">Drug</span> Approvals: Results from a Literature Review
Includes: Supplementary data
Journal Article

The New NIH and FDA Medical Research Policies: Targeting Gender, Promoting Justice

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Karen L. Baird
J Health Polit Policy Law (1999) 24 (3): 531–565.
DOI: https://doi.org/10.1215/03616878-24-3-531
Published: 01 June 1999
...Karen L. Baird The National Institutes of Health (NIH) and Food and Drug Administration (FDA) have both recently revised their policies regarding the inclusion of women in clinical trials. Pressured by women's health activists and members of Congress, the NIH has vastly improved its policies...
View articletitled, The New NIH and FDA Medical Research Policies: Targeting Gender, Promoting Justice View PDF for article titled, The New NIH and FDA Medical Research Policies: Targeting Gender, Promoting Justice
Journal Article

Medicaid and Accelerated Approval: Spending on Drugs with and without Proven Clinical Benefits

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Rachel E. Sachs, Shelley A. Jazowski, Kyle A. Gavulic, Julie M. Donohue, Stacie B. Dusetzina
J Health Polit Policy Law (2022) 47 (6): 673–690.
DOI: https://doi.org/10.1215/03616878-10041107
Published: 01 December 2022
...Rachel E. Sachs; Shelley A. Jazowski; Kyle A. Gavulic; Julie M. Donohue; Stacie B. Dusetzina Abstract Many state Medicaid officials are concerned about rising prescription drug spending, particularly drugs approved through the Food and Drug Administration's (FDA) accelerated approval pathway...
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View articletitled, Medicaid and Accelerated Approval: Spending on <span class="search-highlight">Drugs</span> with and without Proven Clinical Benefits View PDF for article titled, Medicaid and Accelerated Approval: Spending on <span class="search-highlight">Drugs</span> with and without Proven Clinical Benefits
Includes: Supplementary data
Journal Article

Prospects for Enforcing Prohibitions on Off-Label Drug Promotion after United States v. Caronia : An Analysis of Litigated Cases

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Sheng Liu, Michelle M. Mello, Aaron S. Kesselheim
J Health Polit Policy Law (2021) 46 (3): 487–504.
DOI: https://doi.org/10.1215/03616878-8893571
Published: 01 June 2021
...Sheng Liu; Michelle M. Mello; Aaron S. Kesselheim Abstract Context: Food and Drug Administration (FDA) rules restrict pharmaceutical manufacturers from promoting drugs for non-FDA-approved (off-label) indications. When manufacturers violate this rule, it has in many cases led to unsafe prescribing...
FIGURES
View articletitled, Prospects for Enforcing Prohibitions on Off-Label <span class="search-highlight">Drug</span> Promotion after United States v. Caronia : An Analysis of Litigated Cases View PDF for article titled, Prospects for Enforcing Prohibitions on Off-Label <span class="search-highlight">Drug</span> Promotion after United States v. Caronia : An Analysis of Litigated Cases
Includes: Supplementary data
Journal Article

Laetrile and the Fda: A Case of Reverse Regulation

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John F. Cannizzaro, Madelon M. Rosenfeld
J Health Polit Policy Law (1978) 3 (2): 181–195.
DOI: https://doi.org/10.1215/03616878-3-2-181
Published: 01 April 1978
... role of the Food and Drug Administration. Copyright © 1978 by the Department of Health Administration, Duke University Press 1978 Laetrile and the FDA: A Case of Reverse Regulation John F. Cannizzaro, and Madelon M Rosenfeld, Capital University Law School...
View articletitled, Laetrile and the Fda: A Case of Reverse Regulation View PDF for article titled, Laetrile and the Fda: A Case of Reverse Regulation
Journal Article

Evidence and Access to Biomedical Interventions: The Case of Stem Cell Treatments

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Karen J. Maschke, Michael K. Gusmano
J Health Polit Policy Law (2016) 41 (5): 917–937.
DOI: https://doi.org/10.1215/03616878-3632212
Published: 01 October 2016
... should define and assess safety and effectiveness, and how? In the first section of the paper we describe the types of stem cells that may be therapeutically effective. We then describe how the US Food and Drug Administration asserted regulatory authority over certain stem cell interventions...
View articletitled, Evidence and Access to Biomedical Interventions: The Case of Stem Cell Treatments View PDF for article titled, Evidence and Access to Biomedical Interventions: The Case of Stem Cell Treatments
Journal Article

Trust and Regulation: Assuring Scientific Independence in the FDA's Emergency Use Authorization Process

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Neeraj G. Patel, Aaron S. Kesselheim, Jonathan J. Darrow
J Health Polit Policy Law (2023) 48 (5): 799–820.
DOI: https://doi.org/10.1215/03616878-10637726
Published: 01 October 2023
...Neeraj G. Patel; Aaron S. Kesselheim; Jonathan J. Darrow Abstract Since 2004, the US Food and Drug Administration (FDA) has had the authority to allow access to unapproved medical products via the Emergency Use Authorization (EUA) pathway during times of emergency. It was rarely used until...
View articletitled, Trust and Regulation: Assuring Scientific Independence in the FDA's Emergency Use Authorization Process View PDF for article titled, Trust and Regulation: Assuring Scientific Independence in the FDA's Emergency Use Authorization Process
Journal Article

History and Politics of Medication Abortion in the United States and the Rise of Telemedicine and Self-Managed Abortion

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Carrie N. Baker
J Health Polit Policy Law (2023) 48 (4): 485–510.
DOI: https://doi.org/10.1215/03616878-10449941
Published: 01 August 2023
...Carrie N. Baker Abstract This article examines the decades-long campaign to increase access to abortion pills in the United States, including advocates' work to win US Food and Drug Administration approval of mifepristone and misoprostol for abortion, the continuing restrictions on mifepristone...
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View articletitled, History and Politics of Medication Abortion in the United States and the Rise of Telemedicine and Self-Managed Abortion View PDF for article titled, History and Politics of Medication Abortion in the United States and the Rise of Telemedicine and Self-Managed Abortion
Journal Article

Evidentiary Support in Public Comments to the FDA's Center for Tobacco Products

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Natalie Hemmerich, Elizabeth G. Klein, Micah Berman
J Health Polit Policy Law (2017) 42 (4): 645–666.
DOI: https://doi.org/10.1215/03616878-3856121
Published: 01 August 2017
...Natalie Hemmerich; Elizabeth G. Klein; Micah Berman Abstract Electronic Nicotine Delivery Systems (ENDS) were introduced into the US market in 2007, and until recently these devices were unregulated at the federal level. In 2014, the US Food and Drug Administration (FDA) published a Notice...
View articletitled, Evidentiary Support in Public Comments to the FDA's Center for Tobacco Products View PDF for article titled, Evidentiary Support in Public Comments to the FDA's Center for Tobacco Products
Journal Article

Does Policy Uncertainty Boost Vaccine Hesitancy? Political Controversy, the FDA, and COVID-19 Vaccine Hesitancy in Fall 2020

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Daniel Carpenter, Matthew E. Dardet, Anushka Bhaskar, Leah Z. Rand, William B. Feldman ...
J Health Polit Policy Law (2025) 50 (3): 397–437.
DOI: https://doi.org/10.1215/03616878-11670184
Published: 01 June 2025
... COVID-19 vaccines. Findings: Vaccine hesitancy spiked in the United States from late August to early October 2020. The authors identify several plausible triggers for this spike, all pertaining to the Food and Drug Administration and electoral politics. Heightened vaccine hesitancy occurred among...
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View articletitled, Does Policy Uncertainty Boost Vaccine Hesitancy? Political Controversy, the FDA, and COVID-19 Vaccine Hesitancy in Fall 2020 View PDF for article titled, Does Policy Uncertainty Boost Vaccine Hesitancy? Political Controversy, the FDA, and COVID-19 Vaccine Hesitancy in Fall 2020
Includes: Supplementary data
Journal Article

Coexistence, Conflict, and Cooperation: Public Policies toward Medical Devices

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Susan Bartlett Foote
J Health Polit Policy Law (1986) 11 (3): 501–523.
DOI: https://doi.org/10.1215/03616878-11-3-501
Published: 01 June 1986
... the Medical Device Amend- ments of 1976 was to authorize the Food and Drug Administration (FDA) to ensure medical product safety. * The government also promotes innovation, pri- marily through support for basic and applied research.' Congress expanded public access for millions of elderly citizens...
View articletitled, Coexistence, Conflict, and Cooperation: Public Policies toward Medical Devices View PDF for article titled, Coexistence, Conflict, and Cooperation: Public Policies toward Medical Devices
Journal Article

Maximum Allowable Cost: Can the Government Control Drug Costs? A Retrospective Political Analysis of Events and Issues

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Michael Ira Smith, Albert I. Wertheimer
J Health Polit Policy Law (1979) 4 (2): 155–175.
DOI: https://doi.org/10.1215/03616878-4-2-155
Published: 01 April 1979
..., Bethesda, Maryland; Dr. Mark Novitch, Associate Commissioner, Food and Drug Administration., Rockville, Maryland; Dr. James Russo, Vice President for Public Relations, Pharmaceutical Manufacturers Association, Washington, DC. Maximum Allowable Cost: Can the Government Control Drug Costs...
View articletitled, Maximum Allowable Cost: Can the Government Control <span class="search-highlight">Drug</span> Costs? A Retrospective Political Analysis of Events and Issues View PDF for article titled, Maximum Allowable Cost: Can the Government Control <span class="search-highlight">Drug</span> Costs? A Retrospective Political Analysis of Events and Issues
Journal Article

Staff Resources Speed FDA Drug Review: A Critical Analysis of the Returns to Resources in Approval Regulation

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Daniel Carpenter
J Health Polit Policy Law (2004) 29 (3): 431–442.
DOI: https://doi.org/10.1215/03616878-29-3-431
Published: 01 June 2004
.... Food and Drug Administration. 2002 . Improving Public Health through Human Drugs: CDER Report to the Nation 2002 . Rockville, MD: U.S. Food and Drug Administration. Available online at www.fda.gov/cder/reports/rtn/2002/Rtn2002.PDF . Hilts, Philip. 2003 . Protecting American's Health: The FDA...
View articletitled, Staff Resources Speed FDA <span class="search-highlight">Drug</span> Review: A Critical Analysis of the Returns to Resources in Approval Regulation View PDF for article titled, Staff Resources Speed FDA <span class="search-highlight">Drug</span> Review: A Critical Analysis of the Returns to Resources in Approval Regulation
Journal Article

Substantial Equivalence Standards in Tobacco Governance: Statutory Clarity and Regulatory Precedent for the FSPTCA

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Daniel Carpenter, Gregory N. Connolly, Lauren Kass Lempert
J Health Polit Policy Law (2017) 42 (4): 607–644.
DOI: https://doi.org/10.1215/03616878-3774188
Published: 01 August 2017
... Protection and Affordable Care Act of 2010 has received far more public attention, the FSPTCA (21 U.S.C. § 301 [2009]) creates a vast system of federal registration, reporting, and regulation of tobacco products. The Food and Drug Administration (FDA) now assumes the position of gatekeeper to the tobacco...
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View articletitled, Substantial Equivalence Standards in Tobacco Governance: Statutory Clarity and Regulatory Precedent for the FSPTCA View PDF for article titled, Substantial Equivalence Standards in Tobacco Governance: Statutory Clarity and Regulatory Precedent for the FSPTCA
Journal Article

The Role of Courts in Shaping Health Equity

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Mark A. Hall
J Health Polit Policy Law (2017) 42 (5): 749–770.
DOI: https://doi.org/10.1215/03616878-3940432
Published: 01 October 2017
... with its 2006 decision in Abigail Alliance v. Eschenbach (445 F.3d 470 [D.C. Cir. 2006]), holding that the Food and Drug Administration (FDA) must make experimental drugs more readily available to terminally ill patients for whom there are no other therapeutic options. Two of the three judges reasoned...
View articletitled, The Role of Courts in Shaping Health Equity View PDF for article titled, The Role of Courts in Shaping Health Equity
Journal Article

Emergent Patterns in the Regulation of Pharmaceuticals: Institutions and Interests in the United States, Canada, Britain, and France

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Mary E. Wiktorowicz
J Health Polit Policy Law (2003) 28 (4): 615–658.
DOI: https://doi.org/10.1215/03616878-28-4-615
Published: 01 August 2003
... to the participation of private interests in policy making (Alford 1975; Brickman, Jasanoff, and Ilgen 1985). 618 Journal of Health Politics, Policy and Law has led the Food and Drug Administration (FDA) to largely exclude indus- try in policy development, which occurs indirectly through judicial appeal...
View articletitled, Emergent Patterns in the Regulation of Pharmaceuticals: Institutions and Interests in the United States, Canada, Britain, and France View PDF for article titled, Emergent Patterns in the Regulation of Pharmaceuticals: Institutions and Interests in the United States, Canada, Britain, and France
Journal Article

The Politics and Strategy of Industry Self-Regulation: The Pharmaceutical Industry's Principles for Ethical Direct-to-Consumer Advertising as a Deceptive Blocking Strategy

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Denis G. Arnold, James L. Oakley
J Health Polit Policy Law (2013) 38 (3): 505–544.
DOI: https://doi.org/10.1215/03616878-2079496
Published: 01 June 2013
... of Health Politics, Policy and Law 2 , no. 1 : 32 – 47 . Strasburger Victor C. 2004 . “Children, Adolescents, and the Media.” Current Problems in Pediatric and Adolescent Health Care 34 , no. 2 : 54 – 113 . US Food and Drug Administration . 2005 . “FDA Updates Labeling...
View articletitled, The Politics and Strategy of Industry Self-Regulation: The Pharmaceutical Industry's Principles for Ethical Direct-to-Consumer Advertising as a Deceptive Blocking Strategy View PDF for article titled, The Politics and Strategy of Industry Self-Regulation: The Pharmaceutical Industry's Principles for Ethical Direct-to-Consumer Advertising as a Deceptive Blocking Strategy
Journal Article

The Rhetorical Transformations and Policy Failures of Prescription Drug Pricing Reform under the Trump Administration

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Rachel E. Sachs
J Health Polit Policy Law (2021) 46 (6): 1053–1068.
DOI: https://doi.org/10.1215/03616878-9349156
Published: 01 December 2021
... Lev . 2021 . “ States Still Can't Import Drugs from Canada. Now, Many Are Seeking to Import Canadian Prices .” Stat , February 18 . www.statnews.com/2021/02/18/states-canada-drug-prices/ . FDA (Food and Drug Administration) . 2019 . “ Importation of Prescription Drugs .” www.fda.gov...
View articletitled, The Rhetorical Transformations and Policy Failures of Prescription <span class="search-highlight">Drug</span> Pricing Reform under the Trump <span class="search-highlight">Administration</span> View PDF for article titled, The Rhetorical Transformations and Policy Failures of Prescription <span class="search-highlight">Drug</span> Pricing Reform under the Trump <span class="search-highlight">Administration</span>