Citizen Petition Research Articles

Searching for a recipe for success: environmental citizen petitions under free trade agreements

ABSTRACT Submissions on enforcement matters (SEMs) allow civil society members to assert that one party to a free trade agreement (FTA) is failing to enforce its domestic environmental laws. Submissions that survive every step of the SEM process result in a ‘factual record’ prepared by a secretariat on enforcement matters. Relying on qualitative comparative analysis and an original dataset compiling the 158 SEMs submitted under the framework of US FTAs, I investigate what conditions make submissions more likely to succeed in leading to a factual record. I find that the existence of previous submissions dealing with the same facts, submissions against developing countries, and the presence of at least one non-governmental organization as a submitter contribute to a submission’s success, but only in conjunction with other conditions and for a limited number of cases. This result provides overall evidence that secretariats’ decisions are unbiased by the factors examined in this paper.

Response to the FDA Decision Regarding DPYD Testing Prior to Fluoropyrimidine Chemotherapy.

Fluoropyrimidine (FP) chemotherapy is associated with severe, life-threatening toxicities, particularly among patients who carry deleterious germline variants in the DPYD gene. Pretreatment DPYD testing is standard of care throughout most of Europe; however, it has not been recommended in clinical practice guidelines in the United States. Due to increased risk of severe toxicity, a Citizen's Petition asked the US Food and Drug Administration (FDA) to update language in FP drug labels to recommend DPYD testing as part of a boxed warning and recommend FP dose reduction in patients carrying deleterious germline variants. In response, the FDA updated the capecitabine package insert to inform patients about the toxicity risk and test availability and consider DPYD testing. However, the FDA did not include a testing recommendation or requirement, or a boxed warning. Additionally, the FDA did not recommend FP dose adjustment in DPYD variant carriers. This review provides a critical assessment of the DPYD-FP pharmacogenetic association using the FDA's previously published Pharmacogenetic Pyramid, demonstrating that the evidence is compelling for recommending DPYD testing prior to FP treatment. Additionally, the FDA's stated concerns about recommending DPYD testing and DPYD-guided FP dose adjustment are addressed and discussed in the context of the FDA's other genetic testing and dose adjustment recommendations. We call on the FDA to follow our European counterparts in recommending DPYD testing and genotype-based dose adjustment to ensure patients with cancer receive safe and effective FP chemotherapy.

Understanding how the expression of online citizen petitions influences the government responses in China: An empirical study with automatic text analytics

Online participation is an important tool for citizens to express their demands, and it is essential for government agencies to respond to public petitions on time and effectively. However, few studies have focused on the rich textual characteristics within the expression of citizen petitions and the effects on the efficiency of government responses as well as response outcomes. In this study, we construct a theoretical model to explain how sentiments, fields, and detailed contents of online petitions influence the timeliness and text length of the corresponding government responses on the basis of discourse theory and government pressure theory. Using the data on the online petition platform of one provincial government in China, textual features are automatically extracted through text analysis techniques. Multiple regression models are employed with a heterogeneity analysis to examine the model. The results show that more negative sentiments, public interest, and detailed contents in the petitions will impede the timeliness of the corresponding responses and bring about longer responses since such petitions are usually complex and hard to address. These findings help better understand the hidden mechanisms of the interaction between governments and citizens, providing theoretical and practical implications.

Making the Case for Accelerated Withdrawal of Aducanumab.

The controversial approval in June 2021 by the Food and Drug Administration (FDA) of aducanumab (marketed as Aduhelm), Biogen's monoclonal antibody for patients with Alzheimer's disease, raises significant concerns for the dementia field and drug approval process, considering its lack of adequate evidence for clinical efficacy, safety issues, and cost. On 15 December 2021, an international group of clinicians, basic science experts, psychological and social science researchers, lay people with lived experience of dementia, and advocates for public health met to discuss making a recommendation for whether aducanumab's approval should be withdrawn. Attendees considered arguments both in favor of and in opposition to withdrawal and voted unanimously to recommend that the FDA withdraw its approval for aducanumab and to support the Right Care Alliance's filing of a formal Citizen Petition to this effect.

Online citizen petitions related to COVID-19 in South Korean cities: a big data analysis.

What do citizens demand of their governing bodies to cope with the spread of emerging infectious diseases after recognizing the growing danger? What are the similarities and differences in political participation via online citizen petitions regarding COVID-19 across cities with different degrees of pandemic experience? This study aims to answer these questions by examining citizen petitions regarding the COVID-19 pandemic in urban areas of South Korea. The pattern of citizens’ requests is a part of integrative socio-ecological and political systems with spatial and temporal dimensions. We compare the pattern of online citizen petitions in four Korean cities, namely Seoul, Busan, Daegu, and Incheon, some of which were epicenters of the COVID-19 outbreak. By applying relevant big data analysis techniques such as text mining, topic modeling, and network analysis, we compare the characteristics of citizen petitions on COVID-19 in the four cities, particularly whether (and how) they want financial or welfare support or COVID-19 prevention. We find that cities that experience a rapid spread are likely to have more petitions for prevention than for support. By comparison, cities without such experience are likely to have more petitions for support. This study contributes by tracing citizen and local government interactions in response to emerging infectious diseases by empirically analyzing the related big data on petitions. Policy implications suggest that urban authorities should listen to analyze and respond to the urgent needs of citizens.

Make Good the Promises: Reconstruction and Its Legacies, Smithsonian’s National Museum of African American History and Culture, Washington, DC

<i>Make Good the Promises: Reconstruction and Its Legacies</i>, Smithsonian’s National Museum of African American History and Culture, Washington, DC

The Coming of Age of Biosimilars: A Personal Perspective

Biosimilars have come of age over the past 17 years, with 84 approvals in the EU and 35 in the US, representing almost 90% of the world market. While the acceptance of biosimilars in the US is catching up with that in the EU, the cost benefits remain elusive due to the high development barrier and complex distribution system involved, mainly in the US. In the EU, the cost of biosimilars has already dropped 70% or more, and interchangeability is a routine in some European jurisdictions, unlike in the US, where a separate regulatory approval is required. This paper projects significant changes coming in the US and EU’s biosimilars approval requirements that will impact the approval procedures in the rest of the world, leading to dramatic changes in the cost of biosimilars to patients. This perspective is based on the author’s first-hand experience to secure FDA approvals of biosimilars and an extensive analysis of the rationality of testing to demonstrate biosimilarity. Multiple citizen petitions by the author and meetings with the FDA may have prompted the recent announcement by the FDA to award a $5 million research grant to scientists to develop novel testing models to establish biosimilarity, including modifying the interchangeability protocols. Soon, demonstration of biosimilarity will not require animal testing and, in most cases, clinical efficacy testing; over time, the clinical pharmacology testing will be reduced as the regulatory agencies develop more confidence in the safety and efficacy of biosimilars. Biosimilars have come of age; now it is the turn of the developers to grow up, and one way to show this is to challenge the current regulatory guidelines but only on scientific grounds to seek more concessions, for which both FDA and EMA are ready.

In Case You Haven't Heard…

Gabapentin, an anticonvulsant, has now been recommended for Schedule V by Public Citizen. In a petition to the Drug Enforcement Administration and Food and Drug Administration (FDA), the organization last month called the drug “markedly overprescribed” and said it could lead to dependence and overdose deaths. “Gabapentin has been dangerously unscheduled as a controlled substance for too long despite increasing evidence of abuse and misuse and despite its strong similarity to pregabalin, which has been a Schedule V drug for more than 15 years,” said Michael Abrams, senior health researcher with Public Citizen's Health Research Group and lead author of the petition. Gabapentin is widely prescribed for uses not approved by the FDA — “off‐label” uses — including treatment of alcohol use disorder. Gabapentin, even at recommended doses, can cause neurological adverse events, including dizziness, sleepiness, euphoria and other psychedelic effects, dependence, withdrawal symptoms upon discontinuation and addiction, according to Public Citizen. If scheduled, gabapentin would then become yet another medication less available to people whose physicians think they need it. Yet, the potential of harm as the drug has been identified as a contributing factor for opioid overdoses has led to Public Citizen's petition, according to Abrams.

Independent Sun Care Product Screening for Benzene Contamination.

Independent Sun Care Product Screening for Benzene Contamination.

Translating Research into Health Policy: The Citizen Petition Experience with the Food and Drug Administration.

Translating research findings into policy is important. Health policy researchers often testify before Congressional subcommittees and provide background on health policy issues. A rarely used, but important, tool for facilitating translation of research into policy is via filing a Citizen Petition.

The Public Good and the Brazilian State: Municipal Finance and Public Services in São Paulo, 1822–1930

The Public Good and the Brazilian State: Municipal Finance and Public Services in São Paulo, 1822–1930

Effect of Oral Ranitidine on Urinary Excretion of N-Nitrosodimethylamine (NDMA)

In 2019, the US Food and Drug Administration (FDA) received a citizen petition indicating that ranitidine contained the probable human carcinogen N-nitrosodimethylamine (NDMA). In addition, the petitioner proposed that ranitidine could convert to NDMA in humans; however, this was primarily based on a small clinical study that detected an increase in urinary excretion of NDMA after oral ranitidine consumption. To evaluate the 24-hour urinary excretion of NDMA after oral administration of ranitidine compared with placebo. Randomized, double-blind, placebo-controlled, crossover clinical trial at a clinical pharmacology unit (West Bend, Wisconsin) conducted in 18 healthy participants. The study began in June 2020, and the end of participant follow-up was July 1, 2020. Participants were randomized to 1 of 4 treatment sequences and over 4 periods received ranitidine (300 mg) and placebo (randomized order) with a noncured-meats diet and then a cured-meats diet. The cured-meats diet was designed to have higher nitrites, nitrates (nitrate-reducing bacteria can convert nitrates to nitrites), and NDMA. Twenty-four-hour urinary excretion of NDMA. Among 18 randomized participants (median age, 33.0 [interquartile range {IQR}, 28.3 to 42.8] years; 9 women [50%]; 7 White [39%], 11 African American [61%]; and 3 Hispanic or Latino ethnicity [17%]), 17 (94%) completed the trial. The median 24-hour NDMA urinary excretion values for ranitidine and placebo were 0.6 ng (IQR, 0 to 29.7) and 10.5 ng (IQR, 0 to 17.8), respectively, with a noncured-meats diet and 11.9 ng (IQR, 5.6 to 48.6) and 23.4 ng (IQR, 8.6 to 36.7), respectively, with a cured-meats diet. There was no statistically significant difference between ranitidine and placebo in 24-hour urinary excretion of NDMA with a noncured-meats diet (median of the paired differences, 0 [IQR, -6.9 to 0] ng; P = .54) or a cured-meats diet (median of the paired differences, -1.1 [IQR, -9.1 to 11.5] ng; P = .71). No drug-related serious adverse events were reported. In this trial that included 18 healthy participants, oral ranitidine (300 mg), compared with placebo, did not significantly increase 24-hour urinary excretion of NDMA when participants consumed noncured-meats or cured-meats diets. The findings do not support that ranitidine is converted to NDMA in a general, healthy population. ClinicalTrials.gov Identifier: NCT04397445.

The paradox of citizen grievances in China: an institutional logics perspective

Grievance petitioning is a prevailing venue for voicing citizens’ discontent and seeking redress in China. Extant literature documents the simultaneous growth of citizen petitions and local containment, without addressing the dynamics of such a paradox. Inspired by the institutional logics perspective, this study surveyed over 300 onsite petitioners and explored how multiple institutional logics are at work and together produce the paradox. Citizens embrace the grassroots logic, flooding petitions into the grievance system. Local governments follow the state logic, engaging in comprehensive containment. Grievance agencies cope strategically with the rise of citizen petitions and bureaucratic influences, demonstrating the ombudsman logic. Despite local containment and often less than satisfactory resolutions, citizens still hold favorable attitudes toward the grievance system, as well as the top bureaucracy, thus sowing the seeds for more petitions. The paradox manifests the coexistence and interactions of multiple institutional logics, raising challenges for governance and accountability. Points for practitioners The simultaneous growth of citizens’ grievances and local containment presents a paradox. Citizens follow the grassroots logic, filing more petitions. Local governments adhere to the state logic, prescribing containment efforts. In face of competing demands, grievance agencies embrace the ombudsman logic. The coexistence of and interactions among different logics help to explain the recurrent patterns for all parties. Future reforms need to be designed with a sophisticated understanding of interactive institutional logics.

From Bulletin Boards to Big Data

Why do Chinese governments at various levels set up public complaint websites where citizen petitions and government responses can be reviewed by the general public? We argue that it is the result of two factors: strong signals sent by the central government to improve governance, and the availability of new technologies to promote policy innovation. To impress their superiors, local officials adopted newly available commercial technology to innovate existing citizen feedback systems, which presented a developmental trajectory from “openness,” “integration,” to “big data-driven prediction.” Drawing on policy documents and interviews with local politicians and administrators, we provide a chronological perspective of how technical development, central government’s signals and local decision-making have interacted in the past two decades to bring forth today’s public complaint websites. The contingent and non-teleological nature of this development can also be applied to other policies such as the social credit system.

Disservice to Society: A Transnational Analysis of the Canadian Hearing Services

&#x0D; &#x0D; &#x0D; This paper expresses a growing sentiment the author felt as an employee of Canadian Hearing Services, one that is only implied in the Deaf Citizens petition. Namely, that the current operation of CHS is contributing to a disconnect from the Ontario and Canadian deaf communities, but it also signifies a disconnect from something bigger—what the author calls the global deaf network or what Murray (2007) calls “the transnational Deaf public sphere” (p.4)— and therefore the actions taking place at CHS reverberate beyond provincial and national borders. In applying a transnational analysis, the author explores the connections and linkages between CHS and a deaf network that exists globally, which includes CHS’ past participation in large international deaf events and the role of CHS offices in bringing together people who have unique and important experiences engaging with global deaf spaces and networks, and consider if the changes recently implemented at CHS signify an organizational withdrawal from these global spaces and networks. While this discussion only scratches the surface of possible connections linking CHS to a global deaf network, the author aims to add their voice to those calling on CHS to rebuild bridges that have previously linked the organization with deaf networks at local as well as global levels.&#x0D; &#x0D; &#x0D;

Ranitidine Use and Cancer Risk: Results From UK Biobank

Ranitidine (brand name Zantac) is an H2-receptor antagonist (H2-blocker) commonly used to treat gastroesophageal reflux and peptic ulcer disease. After recent studies showed that ranitidine degrades to form high levels of N-nitrosodimethylamine (NDMA), a potent carcinogen in animal models and probable human carcinogen, 1 Valisure citizen petition on ranitidine. https://www.valisure.com/wp-content/uploads/Valisure-Ranitidine-FDA-Citizen-Petition-v4.12.pdf Google Scholar ,2 Emery Pharma Citizen Petition. https://emerypharma.com/wp-content/uploads/2020/01/EP-Ranitidine-FDA-Citizen-Petition-v21-January-2-2020.pdf Google Scholar the US Food and Drug Administration (FDA) requested that ranitidine sales be halted. 3 FDA requests removal of all ranitidine products (Zantac) from the Market. https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market Google Scholar Because the implications for human carcinogenesis remain unclear, we evaluated the association between ranitidine use and cancer risk in UK Biobank.

Extending Exclusivity for Biopharmaceuticals to Deter Competing Generics: A Review of Strategies, Potential Mitigation, and Similarities to Infringement

Some patents confront infringement—unauthorized use of the inventions in the patent—thus violating the exclusive use intent of the U.S. Constitution's creation of the patent system to encourage innovation. In other situations, the reverse occurs—patent holders seek to extend their exclusivity period to prevent competitive entrants. This commonly occurs in biopharmaceutical products markets, where annual revenues on many patented drugs exceed $1 billion per year and (most importantly) where several pathways allow extension of exclusivity. This paper reviews the relevant legislation (Bayh-Dole Act, Orphan Drug Act, Hatch-Waxman Act, and Food and Drug Administration (FDA) Modernization Act) as well as the safety and efficacy regulations of the FDA that control marketing of biopharmaceutical products. The paper then assesses methods used to extend patent exclusivity—some legal, some clearly illegal, and some with ambiguous legal status—in order to deter generic entrants. These methods include using FDA "citizen's petitions," creating generic equivalents of branded drugs to block other generic entrants, deterring potential generic competitors from gaining samples to prove bioequivalence to original formulations, seeking additional patents to extend exclusivity (sometimes for trivial changes), paying potential entrants to delay entry, subdividing the potential patient population to qualify for extensions granted by "orphan drug" status, and (most recently) selling patents to Native American tribes to prevent challenges to their validity. The paper concludes by discussing remedies—primarily legislative—that could either eliminate these actions and/or clarify their legality. Then follows a comparison between these entry-delaying strategies and patent infringement itself.

Life, Liberty, (and the Pursuit of Happiness): Medical Marijuana Regulation in Historical Context

The struggle for access to medical marijuana differs from most other battles for therapeutic freedom in American history because marijuana also has a popular, though controversial, nontherapeutic use—delivery of a recreational high. After considering struggles over the medical use of alcohol during prohibition as a precedent, this chapter relates the history of medical marijuana use and regulation in the United States. The bulk of the chapter focuses on the medical marijuana movement from the 1970s to present. This campaign has been one of the prime examples of a successful extrajudicial social movement for freedom of therapeutic choice. With the exception of a single promising decision in 1975, courts have uniformly rejected arguments for medical marijuana access. But the 1996 passage of Proposition 215 in California triggered a tremendous wave of state measures legalizing medical cannabis, as well as a dramatic change in American attitudes about the issue. This chapter recounts this history in light of the special legal, political, and rhetorical challenges medical cannabis advocates have faced. First, many officials have opposed the legalization of medical marijuana, regardless of whether it offers therapeutic benefits, because of the public health harms and moral degradation they associate with the use of pot. Second, marijuana’s designation as a Schedule I substance under the Controlled Substances Act of 1970, and the DEA’s rejection of multiple citizen petitions to reclassify it, has placed extremely high obstacles in the way of researchers interested in scientifically assessing marijuana’s therapeutic efficacy. Third, federal government policies have lagged behind public preference and state law. Finally, medical marijuana supporters have had to negotiate an invaluable but fraught relationship with advocates for comprehensive marijuana legalization. The perspectives and goals of these two groups have overlapped and conflicted in fascinating and unexpected ways.

Did citizen petitions prolong the number of approval days of generic drugs?

To compare the numbers of approval days of the generic drugs with and without citizen petitions. Data from a previous study were obtained to create a data set containing Food and Drug Administrations (FDA) abbreviated new drug applications (ANDAs) with and without citizen petitions, and their filing and approval dates. Descriptive analyses were conducted. An independent t-test was used to analyze the difference of the numbers of approval days of the generic drugs with and without citizen petitions. A total of 289 ANDAs of 81 drugs submitted between the first quarter of 2008 and the third quarter of 2014 were included. Citizen petitions were submitted for 184 (63.7%) ANDAs during this period. More than a third (36.3%) of all ANDAs had a single petition. Among the ANDAs with the citizen petition, the average number of petitions per ANDA was approximately two. The numbers of approval days of the ANDAs with and without citizen petitions were 1221.7 and 978.6 days, respectively, and they were statistically significantly different (p-value<0.0001). The number of approval days of the generic drugs with citizen petitions was significantly higher than the number of approval days of the generic drugs without citizen petitions.

TSCA citizen petitions and risk evaluations: Are these critical TSCA tools aligned?

Environmental Quality ManagementVolume 29, Issue 2 p. 177-180 WASHINGTON WATCH TSCA citizen petitions and risk evaluations: Are these critical TSCA tools aligned? Lynn L. Bergeson, Corresponding Author Lynn L. Bergeson lbergeson@lawbc.com Bergeson & Campbell, P.C., Washington, D.C. Correspondence Lynn L. Bergeson, Bergeson & Campbell, P.C., Washington, D.C. 20037. Email: lbergeson@lawbc.comSearch for more papers by this author Lynn L. Bergeson, Corresponding Author Lynn L. Bergeson lbergeson@lawbc.com Bergeson & Campbell, P.C., Washington, D.C. Correspondence Lynn L. Bergeson, Bergeson & Campbell, P.C., Washington, D.C. 20037. Email: lbergeson@lawbc.comSearch for more papers by this author First published: 19 December 2019 https://doi.org/10.1002/tqem.21659Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Volume29, Issue2Winter 2019Pages 177-180 RelatedInformation