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Food and Drug Law Journal

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https://www.readbyqxmd.com/read/26827394/the-right-to-try-an-overview-of-efforts-to-obtain-expedited-access-to-unapproved-treatment-for-the-terminally-ill
#1
Alexandra Tsakopoulos, Juyoun Han, Heather Nodler, Valerio Russo
No abstract text is available yet for this article.
2015: Food and Drug Law Journal
https://www.readbyqxmd.com/read/26827393/closing-the-door-to-lost-earnings-under-the-national-childhood-vaccine-injury-act-of-1986
#2
Aaron Levin
After a wave of lawsuits against vaccine manufacturers hindered the profitability and production of life-saving vaccines, Congress enacted The National Childhood Vaccine Injury Act of 1986. The Act offers an incentive for individuals to get vaccinated in order to mitigate the population's exposure to disease, while encouraging the continued production of these serums by pharmaceutical companies. Although imperfect, the Vaccine Act fosters promise in filtering out frivolous claims and,provides a central route for due process to the individuals who suffer from a vaccine-related injury...
2015: Food and Drug Law Journal
https://www.readbyqxmd.com/read/26827392/sperm-banking-as-a-strategy-to-reduce-harms-associated-with-advancing-paternal-age
#3
William C Hudson
Medical studies increasingly link paternal age with disorders in offspring. Associated disorders include autism, bipolar disorder, schizophrenia, and ADHD. Banking one's sperm earlier in life, thereby reducing the effective paternal age at conception, would therefore seem to be a successful strategy for reducing risk to one's eventual offspring. But could a cryopreservation equipment manufacturer or a sperm bank lawfully claim that cryopreservation does more than preserve fertility--that it also prevents disease? This article considers arguments for and against FDA's jurisdiction over such claims, and then makes recommendations for how the agency and Congress should respond...
2015: Food and Drug Law Journal
https://www.readbyqxmd.com/read/26827391/sweet-knowledge-how-declaring-added-sugars-will-help-consumers-make-informed-food-choices
#4
Sarah P McDonough
This paper argues that the Food and Drug Administration (FDA) has the authority to require a declaration of "added sugars" on the nutrition label. FDA has relied on scientific evidence from well-respected sources that concluded that "added sugars" pose a public health concern for Americans; its rule is not arbitrary or capricious. At the same time, there are certain limits on the effectiveness of the "added sugars" rule, especially consumer comprehension. Therefore, FDA should consider more effective front-of-package labeling to clearly communicate the public health risks of "added sugars"...
2015: Food and Drug Law Journal
https://www.readbyqxmd.com/read/26827390/-bringing-a-butter-knife-to-a-gun-fight-salience-disclosure-and-fda-s-differing-approaches-to-the-tobacco-use-and-obesity-epidemics
#5
Josef Weimholt
One might expect--given the vastly different look, feel, and function of the ubiquitous (and innocuous) Nutrition Facts panel and the "inflammatory" graphic warning labels for cigarettes--that the statutes establishing such disclosure requirements would exhibit similar disparities. In fact, the relevant provisions of the Nutrition Labeling and Education Act of 1990 and the Family Smoking Prevention and Tobacco Control Act of 2009 are. quite analogous. Like other mandated disclosures, the nutrition label and the cigarette...
2015: Food and Drug Law Journal
https://www.readbyqxmd.com/read/26827389/comprehensive-legislative-reform-to-protect-the-integrity-of-the-340b-drug-discount-program
#6
Lowell M Zeta
The 40B Drug Discount Program (340B Program) is a federally facilitated program that requires drug manufacturers to provide steep discounts on outpatient prescription drugs to qualifying safety net health care providers. The federal program is intended as a safeguard to ensure access to affordable drugs to the indigeut. However, over the last two decades safety net health care providers have exploited financial incentives under the 340B Program at the expense of drug manufacturers and patients, including the most needy and vulnerable populations-they are committed to serve...
2015: Food and Drug Law Journal
https://www.readbyqxmd.com/read/26630825/a-legislative-reform-for-the-food-safety-system-of-china-a-regulatory-paradigm-shift-and-collaborative-governance
#7
Yonghong Han
After describing the historical development of China's food safety system from the perspectives of legislation and administration, this article discusses progress in its food law (The Draft Amendments to Food Safety Law). As a further legislative reform for China's food safety system, the Draft Amendments to the Food Safety Law contain innovative institutional designs and manifest a regulatory paradigm shift from government-centered governance to collaborative governance. However, the Draft Amendments face challenges in their implementation...
2015: Food and Drug Law Journal
https://www.readbyqxmd.com/read/26630824/do-we-need-stronger-sanctions-to-ensure-legal-compliance-by-pharmaceutical-firms
#8
Marc A Rodwin
The increasing number of enforcement lawsuits against pharmaceutical firms and the large size of settlement payments suggest that misconduct is widespread and even risks slipping into the banalities of ordinary business practices. It also raises questions as to whether current sanctions are an effective means to ensure compliance. This article explores the causes of the frequent illegal conduct, why prosecutors rarely use the strongest sanctions in their arsenal--criminal penalties and debarment from participation in public programs--and asks whether the use of the strongest sanctions would be desirable...
2015: Food and Drug Law Journal
https://www.readbyqxmd.com/read/26630823/the-most-serious-offenses-and-penalties-concerning-unsafe-foods-under-the-food-safety-laws-in-bangladesh-india-and-australia-a-critical-analysis
#9
S M Solaiman, Abu Noman M Atahar Ali
The right to food is an internationally recognized human rignt, which inherently denotes the right to safe food simply because unsafe foods cause different diseases resulting in consumer's disability, organ failure, or even early demise. Food safety currently may not be an issue of public concern in Australia, but it has been a "silent killer" for decades in both Bangladesh and India contributing to deaths of thousands and injuries of millions of others. Unscrupulous businesses have been making money at the cost of immense human casualties with almost complete impunity in Bangladesh...
2015: Food and Drug Law Journal
https://www.readbyqxmd.com/read/26630822/just-a-spoonful-of-sugar-will-land-you-six-feet-underground-should-the-food-and-drug-administration-revoke-added-sugar-s-gras-status
#10
Melissa Marie Card, John Francis Abela
This article assesses whether added sugar meets FDA's standard to be generally recognized as safe ("GRAS"). If added sugar is not GRAS, then manufacturers are subject to premarket approval prior to using added sugar in their products. This article advocates that FDA should issue a Federal Register notice determining that added sugar is not GRAS, allowing FDA to regulate the amount of added sugar used in processed foods, decreasing the health adversities that stem from added sugar consumption.
2015: Food and Drug Law Journal
https://www.readbyqxmd.com/read/26630821/fda-adverse-event-reporting-system-recruiting-doctors-to-make-surveillance-a-little-less-passive
#11
Justin M Mann
Within the last few decades, a shift has taken place in FDA's approach to drug development, with greater emphasis put on postmarketing data collection and less on the traditional premarketing scheme. The FDA Adverse Event Reporting System (FAERS) is the primary system for collecting Adverse Events, but has been criticized for years for the low reporting rate into the system and the poor quality of the information submitted. This paper argues that physicians need to be required to submit adverse event reports to FAERS, because such a requirement (1) would produce a greater number of the high quality reports necessary to better determine causality; (2) is merely an extension of physicians' ethical obligations; and (3) aligns with the approach in the Vaccine Adverse Event Reporting System (VAERS)...
2015: Food and Drug Law Journal
https://www.readbyqxmd.com/read/26302603/synthetic-biology-in-the-fda-realm-toward-productive-oversight-assessment
#12
Leili Fatehi, Ralph F Hall
Synthetic biology (SB) is expected to create tremendous opportunities in a wide range of areas, including in foods, therapeutics, and diagnostics subject to regulatory oversight by the United States Food and Drug Administration. At the same time, there is substantial basis for concern about the uncertainties of accurately assessing the human health and environmental risks of such SB products. As such, SB is the latest in a string of emerging technologies that is the subject of calls for new approaches to regulation and oversight that involve "thinking ahead" to anticipate governance challenges upstream of technological development and adopting oversight mechanisms that are both adaptive to new information about risks and reflexive to performance data and feedback on policy outcomes over time...
2015: Food and Drug Law Journal
https://www.readbyqxmd.com/read/26302602/revising-the-regulation-of-stem-cell-based-therapies-critical-assessment-of-potential-models
#13
Barbara von Tigerstrom
The regulation of stem cell-based therapies is challenging in many respects, given their unique safety, efficacy, and quality issues. At the same time, public interest in these innovative therapies has led some to question FDA's regulation of them, while others urge strict regulation and stronger enforcement. Within the context of this broader debate, this article examines recent attempts in other jurisdictions to craft specific provisions allowing additional flexibility in regulating cell and tissue therapies: Australia's exemption for autologous cell and tissue therapies, and the hospital exemption in Europe's regulation for advanced therapies...
2015: Food and Drug Law Journal
https://www.readbyqxmd.com/read/26302601/an-unfulfilled-promise-changes-needed-to-the-drug-approval-process-to-make-personalized-medicine-a-reality
#14
Margaret Foster Riley
The widespread availability of drugs for personalized medicine has been an aspiration since before the human genome was sequenced. Recently, there is renewed interest; personalized medicine is much in the news. Legislation has been considered with the goal of smoothing, shortening and incentivizing the approval process for therapeutic products. President Obama mentioned the need for new initiatives to achieve such goals in the State of the Union address. But most of these initiatives do not consider the fundamental changes that personalized medicine demands...
2015: Food and Drug Law Journal
https://www.readbyqxmd.com/read/26302600/the-limits-of-fda-s-authority-to-regulate-clinical-research-involving-high-throughput-dna-sequencing
#15
Barbara J Evans
The United States Food and Drug Administration (FDA) recently signaled its interest in subjecting clinical investigations that employ high-throughput gene sequencing, also called next-generation sequencing, to the agency's Part 812 investigational device exemption (IDE) regulation. Genome sequencing--for reasons explained in this article--blurs the line between categories of in vitro diagnostic (IVD) research that FDA traditionally has regulated and categories of research that FDA traditionally has not regulated...
2015: Food and Drug Law Journal
https://www.readbyqxmd.com/read/26302599/a-new-wave-of-vaccines-for-non-communicable-diseases-what-are-the-regulatory-challenges
#16
Jonathan J Darrow, Aaron S Kesselheim
Vaccines represent one of the greatest achievements of medicine, dramatically reducing the incidence of serious or life-threatening infectious diseases and allowing people to live longer, healthier lives. As life expectancy has increased, however, the burden of non-communicable diseases (NCDs) such as cancer, hypertension, atherosclerosis, and diabetes has increased. This shifting burden of disease has heightened the already urgent need for therapies that treat or prevent NCDs, a need that is now being met with increased efforts to develop NCD vaccines...
2015: Food and Drug Law Journal
https://www.readbyqxmd.com/read/26302598/remarks-of-the-fda-commissioner-the-food-and-drug-law-institute-s-58th-annual-conference
#17
Stephen Ostroff
No abstract text is available yet for this article.
2015: Food and Drug Law Journal
https://www.readbyqxmd.com/read/26292478/scouting-for-approval-lessons-on-medical-device-regulation-in-an-era-of-crowdfunding-from-scanadu-s-scout
#18
Colleen Smith
Internet crowdfunding, a new and increasingly popular method of raising capital to develop products and businesses, has recently come into conflict with the Food and Drug Administration's (FDA's) regulation of medical devices. This Article examines the issues that arise when companies pre-sell medical devices via crowdfunding campaigns before gaining FDA approval of the devices. Because Internet crowdfunding has only been in use for a few years, little has been written about it academically, particularly about its interaction with FDA regulations...
2015: Food and Drug Law Journal
https://www.readbyqxmd.com/read/26292477/drugs-devices-discovery-using-fee-shifting-to-resolve-the-twombly-iqbal-problem-for-parallel-claims-under-the-fdca
#19
Cameron T Norris
The Supreme Court's decisions in Twombly and Iqbal ushered in a new federal pleading standard, requiring plaintiffs to state a "plausible" claim to relief before they can access discovery. Plausibility pleading, however, presents a unique burden for plaintiffs who have been injured by a Class III medical device. In Riegel, the Supreme Court held that state-law claims against device manufacturers are preempted unless they "parallel" federal requirements. However, the relevant federal requirements are located in the manufacturer's premarket approval agreement, which is confidential...
2015: Food and Drug Law Journal
https://www.readbyqxmd.com/read/26292476/can-you-diagnose-me-now-a-proposal-to-modify-fda-s-regulation-of-smartphone-mobile-health-applications-with-a-pre-market-notification-and-application-database-system
#20
Stephen McInerney
Mobile applications provide limitless possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the Food and Drug Administration (FDA) has the authority to regulate a much broader spectrum of products beyond traditional medical devices like stethoscopes or pacemakers. The regulatory question is not if FDA has the statutory. authority to regulate health-related software, but rather how it will exercise its regulatory authority...
2015: Food and Drug Law Journal
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