Food and drug law journal Impact Factor & Information

Publisher: Food and Drug Law Institute (U.S.)

Journal description

Current impact factor: 0.34

Impact Factor Rankings

2015 Impact Factor Available summer 2015
2013 / 2014 Impact Factor 0.34
2012 Impact Factor 0.373
2011 Impact Factor 0.758
2010 Impact Factor 0.514
2009 Impact Factor 0.526
2008 Impact Factor 0.765
2007 Impact Factor 0.758
2006 Impact Factor 0.397
2005 Impact Factor 0.351
2004 Impact Factor 0.485
2003 Impact Factor 0.404
2002 Impact Factor 0.582
2001 Impact Factor 0.557
2000 Impact Factor 0.771
1999 Impact Factor 0.622
1996 Impact Factor 0.287
1995 Impact Factor 0.103
1994 Impact Factor 0.154
1993 Impact Factor 0.106
1992 Impact Factor 0.083

Impact factor over time

Impact factor
Year

Additional details

5-year impact 0.39
Cited half-life 7.60
Immediacy index 0.05
Eigenfactor 0.00
Article influence 0.13
Website Food and Drug Law Journal website
Other titles Food and drug law journal
ISSN 1064-590X
OCLC 26135015
Material type Periodical, Internet resource
Document type Journal / Magazine / Newspaper, Internet Resource

Publications in this journal

  • [Show abstract] [Hide abstract]
    ABSTRACT: Social media marketing is the next frontier for direct-to-consumer advertising of pharmaceutical products, but represents an unchartered territory for regulatory action. With explosive growth in the use of social media, along with pharmaceutical companies' increasing adeptness at taking advantage of opportunities for social media marketing, the Food and Drug Administration (FDA) faces an urgent need to develop its own capacities to monitor and engage with social media marketing. In response to potential FDA action, pharmaceutical companies' marketing, regulatory compliance and legal staffs must work closely to design initiatives that are sensitive to FDA concerns. This article will address the current status of FDA regulations on social media advertising, their historical origins, challenges to implementation, and their likely future direction.
    Food and drug law journal 01/2014; 69(1):39-51, ii.
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    ABSTRACT: Regulatory bodies weighing market approval for novel medical devices must balance the benefits and potential hazards carefully. We performed a legal and policy review of appraoches in the US, EU, Japan, and China to device regulation with a focus on postmarket surveillance. These markets share broad features such as a heavy reliance on passive adverse event collection, reflected by growing enthusiasm for more active and dynamic mechanisms such as unique device identification. More immediately, US and EU systems might benefit from scheduled, compulsory, and consequential re-examination of select devices, as is done in Japan and China, in order to strengthen post-market protection of patients and bolster public health.
    Food and drug law journal 01/2014; 69(1):1-23, i.
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    ABSTRACT: The Affordable Care Act requires certain restaurants to provide nutritional information on their menus and menu boards, which is referred to as menu labeling. Menu labeling presupposes that providing consumers with the nutritional information about their food will cause them to reconsider their food choices by picking healthier food options over less healthy options, thereby reducing the nation's high obesity rate. However, several studies have shown that consumers do not make healthier food choices even when armed with menu labeling. The issue then becomes whether menu labeling provides a correlative benefit to consumers or whether there are unintended consequences that ultimately harm consumers.
    Food and drug law journal 01/2014; 69(4):531-54, i.
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    ABSTRACT: The safety of FDA-approved drugs remains a significant concern for patients and medical practitioners. This paper argues that pharmacogenomics can complement pharmacologic class effects in drug-safety management, and their use can be implemented without excessive costs or other impracticalities. Section I of this paper introduces key data, concepts and terms; Section II discusses the phenomenon of pharmacologic class effect as well as the relationship between this phenomenon and the use of pharmacogenomics in both FDA regulation and medical practice; and Section III proposes a means by which simultaneous consideration of pharmacologic class effect and pharmacogenomics can improve the quality of selective risk management.
    Food and drug law journal 01/2014; 69(4):603-23, ii.
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    ABSTRACT: In the United States, genetically modified (GM) foods are labeled no differently from their natural counterparts, leaving consumers with no mechanism for deciphering genetically modified food content. The Food and Drug Administration (FDA) has not formally defined the term "natural," which is frequently used on food labels despite consumer confusion as to what it means. The FDA should initiate a notice and comment rulemaking addressing the narrow issue of whether use of the word "natural" should be permitted oil GM food labels. Prohibition of the use of"natural" on genetically modified foods would mitigate consumer deception regarding genetically modified food content without significantly disadvantaging genetically modified food producers.
    Food and drug law journal 01/2014; 69(4):575-601, ii.
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    ABSTRACT: A number of states have enacted statutes that provide protection to drug manufacturers in product liability actions. Additionally, several of these states have enacted "fraud-on-the-FDA" statutory provisions, which remove statutory protection afforded to drug manufacturers in product liability actions if plaintiffs can provide evidence that the drug manufacturer made misrepresentations to the FDA during the process of obtaining marketing approval for the drug. Currently, the federal circuits are in disagreement over whether these state "fraud-on-the-FDA" statutes should be federally preempted. This issue warrants resolution for drug manufacturers, private citizens, and state legislatures. This Comment will discuss the history and role of the FDA's authority in drug and medical device regulation; federal preemption generally and the Supreme Court's decisions that considered whether state law failure to warn claims are federally preempted in the context of drugs and medical devices; the Supreme Court's decision in Buckman v. Plaintiffs' Legal Committee, where the Court held that claims that a medical device manufacturer made fraudulent representations to the FDA were federally preempted because such claims interfered with the relationship between the FDA and the entities it regulated, state fraud-on-the-FDA statutory provisions, and the existing circuit split regarding whether those statutes should be federally preempted; the potential resolutions to the circuit split; and will conclude and advocate that the Supreme Court's Buckman holding be applied to federally preempt state fraud-on-the-FDA statutes because such statutes involve the relationship between a federal agency and the entity it regulates and thus undermine the FDA's authority.
    Food and drug law journal 01/2014; 69(1):113-36, iii.
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    ABSTRACT: As obesity rates continue to rise in the United States, both physicians and patients have demanded more safe and effective drug treatment options. However, following the fen-phen/Redux and sibutramine failures, the FDA has been hesitant to approve any anti-obesity drugs, despite the magnitude of the epidemic. Some have argued that these public embarrassments have led the FDA to overestimate the risks and underestimate the benefits when deciding whether to approve new anti-obesity drugs. On June 27, 2012, the FDA approved Belviq for chronic weight management, making it the first anti-obesity drug approved by the FDA in thirteen years. Less than one month later, the FDA approved Qsymia for the treatment of obesity. Both drugs had been denied FDA approval less than two years earlier. In this paper, I will first review the obesity crisis and discuss the high-profile market withdrawals of fenfluramine, dexfenfluramine, and sibutramine. Second, I will explain the FDA's drug approval process with a focus on the FDA's risk/benefit calculus. Third, I will compare the FDA's risk/benefit analysis for Qsymia and Belviq in 2010 with the agency's risk/benefit analysis in 2012 to determine what caused the agency to grant approval in 2012 while denying it in 2010. Finally, I will analyze what these drug approvals may mean for the future of other anti-obesity drugs.
    Food and drug law journal 01/2014; 69(1):87-111, ii-iii.
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    ABSTRACT: In 2012, American Broadcasting Companies, Inc. (ABC) broadcast a segment on its evening news show regarding the manufacture of "lean finely textured beef" by Beef Products, Inc. (BPI). The broadcast, as well as follow-up reports and social media communications, repeatedly referred to the product as "pink slime," a term originated by a United States Department of Agriculture (USDA) employee for the processed meat. The market backlash against the product was immediate and intense. Ultimately, BPI closed three processing plants, cut hundreds of jobs, and filed for bankruptcy. BPI sued ABC and others for food libel, defamation, and tortious interference. This research analyzes those claims and defenses and discusses the future of such cases.
    Food and drug law journal 01/2014; 69(4):625-47, iii.
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    ABSTRACT: In 2010, the Institute of Medicine (IOM) recommended that the Food and Drug Administration modify the generally recognized as safe status of sodium by setting gradually decreasing limits on sodium amounts allowed in processed and prepared foods. Establishing limits on sodium uses would lead to a decrease in sodium intake, which, on average, far exceeds dietary recommendations. This article discusses the historical and regulatory context surrounding the IOM's recommendation, analyzes its potential, offers various strategies for implementing it, and concludes that the IOM's recommendation is likely the best tool currently available to achieve widespread sodium reductions in the food supply.
    Food and drug law journal 01/2014; 69(1):53-85, ii.
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    ABSTRACT: A Drug Enforcement Administration ("DEA") registration is not only a necessity, but also an invaluable commodity for doctors, pharmacists, hospitals and drug wholesalers who prescribe, stock, and distribute controlled substances. While the DEA may only suspend a registration by issuing an immediate suspension order ("ISO) after an ex parte finding of "imminent danger to the public health or safety," the law fails to explicitly protect the registrant by way of a post-suspension hearing on the ISO, despite the registrant's constitutionally protected property interest in the registration. A registrant has only two procedural options--which are often unsuccessful--to challenge the ISO: endure a long and arduous administrative review proceeding or petition the court for a "not-so-easily proven" injunction, all the while the suspension remains in effect and the controlled substance business operations cease. Accordingly, a suspension of the registration may be certain death to doctors and pharmacists without the financial means to operate the business in the absence of the registration. Because the DEA registration is a constitutionally-protected interest, there is a better way to challenge the suspension. The Supreme Court has held that once a license is issued, the continued possession of it is essential to the registrant's livelihood. Therefore suspension or revocation of such a protected interest requires due process. Due-process hearings, while varied, will provide the necessary avenues of review to provide a fair review of the justification of the suspension and its continuance, i.e., whether there truly is imminent danger to public health or safety and whether the suspension is overbroad and should be limited. To date, this thesis remains to be tested and awaits a petitioner with a justiciable claim and the financial resources to challenge the DEA in court. But in the field of DEA ISO challenges, it is time for a new tact!
    Food and drug law journal 01/2014; 69(1):25-38, i.
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    ABSTRACT: The United States' medical device color additive regulations are unknown to some, and confusing to many. This article reviews statutory language on color additives in the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended, including the Delaney Clause on carcinogenicity; color additive regulatory language as it relates to medical devices in Title 21 of the Code of Federal Regulations (C.F.R.), Parts 70-82; reports on the Food and Drug Administration's (FDA's) likely current and historical practices in dealing with color additives in medical devices; and speculates on what may have given rise to decades of seemingly ad hoc color additives practices, which may now be difficult to reconstruct and satisfactorily modify. Also addressed is the Center for Devices and Radiological Health's (CDRH's) recent publicly-vetted approach to color additives in Section 7 of its April 2013 draft guidance, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," which the author concludes is a change in the right direction, but which, at least in its current draft form, is not a fix to the CDRH's color additives dilemma. Lastly, the article suggests what the CDRH might consider in further developing a new approach to color additives. Such an approach would treat color additives as if they were any other potentially toxic group of chemicals, and could be fashioned in such a way that the CDRH could still satisfy the broad aspects of Congressional color additives mandates, and.yet be consistent with ISO 10993. In doing this, the CDRH would need to recommend a more directed use of its Quality System Regulation, 21 C.F.R. Part 820, for material and vendor qualification and validation in general; approach Congress for needed statutory changes; or make administrative changes. In order for any approach to be successful, whether it is a new twist on past practices, or an entirely new path forward, the FDA must, to the best of its ability, better understand its past medical device color additive practices (as well as the variations that have developed within the last twenty or so years), and engage in a dialogue with stakeholders on how it and the medical device industry should consider unlisted color additives currently used in marketed devices in the United States.
    Food and drug law journal 01/2014; 69(4):491-529, i.
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    ABSTRACT: Therapies born out of the Hygiene Hypothesis--such as helminthic therapy and fecal bacteriotherapy--provide a compelling example of the FDA's institutional blindness. Unlike the traditional pharmaceutical model of treatment, therapies based in the Hygiene Hypothesis purport to resolve or alleviate conditions by reintroducing organisms once thought to be wholly negative. While questions of negative effects and safety remain in the former, they are largely absent in the latter. Nonetheless, the FDA has chosen to regulate the use of both helminthic therapy and fecal bacteriotherapy. Such restriction of doctor-patient autonomy in the name of efficacy is costly and unethical.
    Food and drug law journal 01/2014; 69(4):555-74, ii.
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    ABSTRACT: FDA transparency effort continued, including the Secretary's adopting eight measures to improve access to Agency information and activities. A continuing problem was shortages of prescription drugs, which probably was enhanced by increased manufacturing recalls. FDA issued more device Guidances for regulatory clarity. Enforcement involving drugs and devices increased, including GMP and GLP enforcement and surveillance of internet claims. The Supreme Court decided generic drug manufacturers may cause the FDA to revise incorrectly listed use codes, and pharmaceutical detailers may not receive overtime payments. FDA initiated implementation of the Food Safety and Modernization Act, including two pilot tracking systems for supply chain tracing and to determine how quickly data can be gathered. The Agency issued guidance for new dietary supplements. FDA failed to impose graphic labeling requirements on the tobacco industry, but established it can regulate electronic cigarettes as tobacco. The Agency issued guidelines for the use of nanomaterials in cosmetics, and reviewed the effectiveness of sunscreen products. FDA is being given more authority over larger areas of the U.S. economy, but its resources are not increased proportionately. The pharmaceutical industry made major payments for alleged violations of the Drug Rebate Statute, Anti-Kickback Statute, Wholesale Price and Off-Label Use prohibitions. The government continues using the Responsible Corporate Officer doctrine to make company managers responsible for corporate conduct about which they had no knowledge. Companies should have a robust compliance program in effect. The FTC and the SEC continue their oversight activities, including SEC's enforcement of the Foreign Corrupt Practices Act. The defense of product liability litigation continues grappling with federal preemption of state laws.
    Food and drug law journal 01/2013; 68(1):1-51, i.
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    ABSTRACT: FDA's proposed graphic warning labels for cigarette packages have been scrutinized for potentially violating the First Amendment's free speech clause. This article addresses the distinction between the commercial speech and compelled speech doctrines and their applicability in analyzing the constitutionality of the labels. The government's position is that the labels evoke an emotional response and educate consumers, while tobacco companies argue that the labels forcibly promote the government's message. Two federal appellate courts, applying different legal standards, have arrived at different conclusions. This article advocates that the Supreme Court, if faced with review of the labels, should apply strict scrutiny and declare the labels unconstitutional.
    Food and drug law journal 01/2013; 68(4):329-56, i.
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    ABSTRACT: The FDA approved Depo-Provera, an injectable contraceptive, in 1992 on the condition that its manufacturer conduct a post-approval study on the risk ofosteoporosis. Then in 2004, the agency revised the drug's labeling to include a boxed (i.e. Black Box) Warning on the risk ofosteoporosis. This article will analyze the FDA's Depo-Provera approval and label revision process: the agency's acceptance of Upjohn's New Drug Application, its Fertility and Maternal Health Advisory Committee's review of the human clinical studies and approval recommendation, its marketing approval of Depo-Provera, and its 2004 drug labeling revision. Then the article will analyze the post-2004 products liability litigation by women who claimed to have been injured by their use of the drug. None of the cases have survived the manufacturer's summary judgment motions, because the women have been unable to establish by expert and physician evidence that the FDA-approved labeling was inadequate to inform their physicians of the risk of osteoporosis, that the inadequate warnings caused their osteoporosis or osteopenia, and that these are compensable injuries. As a result, the manufacturer has been able to use the FDA labeling, state products liability law, and the learned intermediary doctrine to avoid liability. The conclusion will consider the lessons of these products liability cases for other women who have received Depo-Provera and suffered bone mineral density loss.
    Food and drug law journal 01/2013; 68(2):115-35, i.
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    ABSTRACT: China has significant gaps and weaknesses in its regulatory oversight of the off-label use of drugs. As in the United States, the off-label prescribing of drugs is not prohibited in China if there is a sound scientific basis. Physicians are allowed to prescribe off-label drugs based on their medical judgment if they follow certain requirements. There is some constraint on the right to prescribe by the imposition of malpractice liability if patients are harmed from improper off-label prescribing. However, damages awarded to successful plaintiffs are usually insignificant compared to malpractice damage awards in the U.S. Advertisement of off-label use is prohibited in China. All drug advertisements in China are subject to pre-approval, and must be based on information included in the approved package insert. However, the term "advertisement" is poorly defined. As a result, non-advertisement promotion of drugs for on-label or off-label use exist in a unregulated gray area. To better address the problem of inappropriate off-label promotion and use, China should (i) regulate both drug advertisements and non-advertisement promotion under a standard requiring off-label use to have a sound scientific basis, (ii) introduce harsher regulatory penalties, and (iii) increase compensation available for victims of medical malpractice. Such reform would not only discourage improper off-label use by introducing penalties (or increasing existing penalties) for improper promotion, but would also provide reasonable compensation for victims harmed by off-label use.
    Food and drug law journal 01/2013; 68(2):189-200, ii.
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    ABSTRACT: Breakthrough medical tools and technologies are rapidly becoming available in countries across the world, but cannot be purchased in the United States, where these innovative products still await FDA approval. The artificial pancreas is a prime example of such medical technologies, as one of these device systems has been available in over 40 countries outside of the United States for more than 3 years. The term "artificial pancreas" refers to any one of a group of closed-loop device systems designed to protect type 1 diabetics against dangerous diabetes episodes, while also reducing the risk of diabetes-related complications by enabling tighter glycemic control. The following paper will provide an overview of diabetes, a brief history of diabetes management, the technological challenges of creating a fully functional closed-loop diabetes management system, and the role of FDA in the development of the artificial pancreas.
    Food and drug law journal 01/2013; 68(1):53-76, i.
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    ABSTRACT: Since 2004, 25 states have passed Commonsense Consumption Acts (CCAs) to shield the food industry from civil liability for claims arising from obesity-related health harms. These laws continue to be introduced. CCAs have generally been discussed in terms of "tort reform." For this article, we conducted a systematic analysis of the content of all 25 state laws and found that the potential impact of CCAs goes well beyond obesity-related tort reform to limits on state Attorney General (AGs) authority and significant reforms to future statutory consumer protection claims by AGs, individuals and classes of consumers. Moreover, every CCA state had pre-existing legal protections against frivolous litigation-greatly undercutting arguments made by CCA proponents.
    Food and drug law journal 01/2013; 68(3):229-39, i.
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    ABSTRACT: Biotechnology has evolved beyond the realm of child's guess-and-check to a precise science, and now promises to help solve some of the globe's most pressing challenges, including food insecurity and environmental degradation. Beyond this, biotechnology also represents an important part of the American intellectual property landscape. Unlike transgenic plants, no transgenic animals have yet to reach the American dinner table, despite the fact that transgenic animals offer cheap, healthy, and an environmentally friendly source of protein. AquaBounty's AquAdvantage Salmon, which counts itself among the most heavily regulated product in the Food and Drug Administration's history, suffers greatly from negative stigma from special interest groups and the media. This article will examine the important role of biotechnology in America's intellectual property market, the regulation of the AquAdvantage Salmon, and transgenic animal products more generally, before FDA, as well as some of misinformation about AquAdvantage that has been presented to the American public. This article additionally advocates for FDA to adopt a more proactive public outreach role in explaining to the American public, in terms accessible to the layperson, what a transgenic animal product is, how FDA regulates transgenic animal products, and why FDA feels these products are safe for human consumption. In doing so, this article hopes to establish that FDA is best suited to provide the American public with objective facts surrounding this highly stigmatized product.
    Food and drug law journal 01/2013; 68(3):281-307, ii.