Generic drug competition: The pharmaceutical industry “gaming” controversy

Among American adults 20 years and older, 59 percent take at least one prescription drug on a regular basis. Unlike most branded drugs, which are generally drugs that have a trade name and are protected by a patent, off‐patent generic drugs make up approximately 90 percent of prescriptions annually filled in the United States; yet in 2017, generic drugs made up only 23 percent of total drug costs in the U.S. The U.S. Food and Drug Administration has taken the lead in encouraging increased competition in the nation’s prescription drug marketplace, most recently with its release of the agency’s Drug Competition Action Plan, but also with its regulatory guidance and enforcement efforts to eliminate “gaming” of the regulatory process by both branded and generic pharmaceutical manufacturers. Such “gaming” activities include “pay‐for‐delay” agreements involving financial compensation between branded and generic pharmaceutical manufacturers to forestall the emergence into the market of generic pharmaceuticals to compete against a formerly patent‐protected branded drug. A combination of new enabling legislation, federal judicial guidance, and agency regulatory activities show promise in encouraging increased competition in the prescription drug marketplace, with the American consumer the ultimate beneficiary of lower health care costs and improved overall personal health.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/152498/1/basr12186_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/152498/2/basr12186.pd

Global Environmental Law: Food Safety & China

This article makes the case for food security law and policy as a component of global environmental law in recognition of the global economy, trade liberalization, and concerns for food safety and environmental harm. It further describes rule of law as a significant force in mitigating food safety concerns and pollution in China. Part II explores global food safety concerns in the context of United States-China relations, while Part III discusses the U.S. Food & Drug Administration\u27s on-the-ground presence in China as an example of the emergence of cooperative agreements in global environmental governance. Part IV shows how increased rule of law may mitigate environmental harm and food safety concerns in China. The article concludes by arguing that increased international cooperation on traditionally domestic issues is both likely and desirable, and it illustrates the need for increased rule of law efforts in the developing world

Food Law & Policy: The Fertile Field's Origins and First Decade

Legal knowledge, learning, and scholarship pertaining to the production and regulation of food historically centered around two distinct fields of law: Food & Drug Law and Agricultural Law. The former focuses on the regulation of food by the Food and Drug Administration under the Food, Drug, and Cosmetic Act, while the latter examines the impacts of law on the agricultural sector’s production of food and fiber. Neither field—alone or in tandem—focuses in whole or in part on many of the most pressing legal issues that currently impact our food system. Consequently, elements of these two fields converged roughly one decade ago to create a significant and distinct new field of legal study: “Food Law & Policy.” This field explores legal and policy issues well outside the scope of Food & Drug Law and of Agricultural Law to address important questions about food that had never been explored fully within the legal academy. Food Law & Policy embraces a broader study of laws and regulations at all levels of government that impact the food system—covering everything from local regulations pertaining to farmers’ markets or food trucks to federal policies pertaining to obesity or hunger. Food Law & Policy now enjoys a strong and growing presence throughout the legal academy. This Article introduces ten categories of original empirical data to document the field’s vitality—including figures on law school courses, legal scholarship, clinical legal programs, and student societies at U.S. law schools. It details the past and present of Food & Drug Law and Agricultural Law alongside that of Food Law & Policy. The Article demonstrates that Food Law & Policy has proven to be a timely and vibrant addition to the legal academy and suggests next steps in the ongoing development of the field

Undue Process at the FDA

For over 40 years, the Food and Drug Administration has been collecting evidence that the routine administration of antibiotics to animals destined for the food supply contributes to the development of antibiotic-resistant infections in the human population. For all these years, the FDA has put off acting with any force on this health risk. The agency’s explanation has been that the Food, Drug and Cosmetic Act requires it to hold time- and resource-intensive formal hearings before it can withdraw approvals for antibiotics used for the purposes of promoting growth and preventing infection in food animals. In so arguing, the FDA has ignored decades of developments in administrative law and has misread its own statute. The FDA has the discretion under the law to act on antibiotics in animal feed without going through the years-long process of formal hearings. At the least, the agency owes the public an explanation of why it has insisted on pursuing the longest possible path to protecting human health. The FDA’s legal error is, in principle, simple enough to correct. Far less remediable are the habits of mind that entrench agency inaction, including institutional memory that privileges stasis over change and systematic acceptance of absurdly long timelines for addressing social problems. Equally immobilizing are statutory grants of epistemic authority to particular individuals within large bureaucratic institutions, which allow these institutions officially to deny certain facts about the world even while they report them as the truth

Peranan Penyidik Pegawai Negeri Sipil Balai Besar Pengawas Obat dan Makanan dalam Menertibkan Peredaran Mie Kuning Basah yang Mengandung Zat Berbahaya Berdasarkan Undang-undang Nomor 18 Tahun 2012 Tentang Pangan di Wilayah Hukum Kota Pekanbaru

Currently, many food products are not suitable for consumption because it contains substances that are harmful to the human body are still free beredar.Zat-harmful substances are not only found on the product label but also on traditional foods, one yellow noodles basah.Produsen fraudulent use of hazardous substances in the processing of wet yellow noodles so the noodles remain resistant and the colors that attract consumers, but this is very detrimental to consumers in terms of health because it can endanger the health of consumers.As for the purpose of this thesis is how the role, barriers, and efforts Civil Servant Investigators Great Hall of the Food and Drug Administration to regulate the circulation of yellow noodles soggy containing hazardous substances based on Law No. 18 Year 2012 on Food in the jurisdiction of the city of Pekanbaru ,The conclusion that can be derived from this study is the first, the role of Civil Servant Investigators Great Hall of the Food and Drug Administration Pekanbaru not the maximum, due to very maze of cases handled by the investigator until today. Second, barriers faced by Civil Servant Investigators Great Hall of the Food and Drug Administration Pekanbaru is influenced by several factors such as law, law enforcement officers factors, factors and factors humans. infrastructure, efforts in overcoming the barriers that do Servant Investigators civil Hall of the Food and Drug Administration Pekanbaru is to add members investigator, enhance the effectiveness of HR in the organization, increasing cooperation with the police, increase the budget for the purpose of investigation and to disseminate to the public. Suggestions author of the issues examined are the First, that Civil Servant Investigators Great Hall of the Food and Drug Administration Pekanbaru can play its role to the fullest. Secondly, in order that Civil Servant Investigators Great Hall Pekanbaru Food and Drug Administration to coordinate with the police, businesses and people in the discipline circulation wet yellow noodles containing berbahaya. Thirdsubstances, are not expected to increase the number of personnel investigator and increase the budget for the purpose of investigation

PENTINGNYA PENCANTUMAN LABEL HALAL PADA OBAT BAGI KONSUMEN MUSLIM DITINJAU DARI PASAL 4 HURUF (C) UNDANG-UNDANG NOMOR 8 TAHUN 1999 TENTANG PERLINDUNGAN KONSUMEN

The importance of inclusion of lawful label on the drug circulating in Indonesia is a right and a means for Muslim consumers to get the right information, clear and honest. Inclusion is being lawful label of freedom and security for the fulfillment of basic rights which every citizen the right to embrace a religion and perform according to his religious beliefs worship as free - free. lawful labeling on is one form of attention or consumption of a product selection by the Islamic religion, in this case Moslems consumers in order to carry out worship according to his faith. Religion Islam provides relevant rules and limits of a lawful or illegitimate goods as a product of absolute mandatory requirement to be followed and obeyed by Moslems consumers.\ud \ud Based on the above reasons, the author suggests two problems namely, how the form of legal protection for Moslems consumers in fulfilling the right to get the drug and the second is how the importance of inclusion of lawful label on the drug as a form of obligation to the consumer business lawful under article 4 letter (c) Law - Law number 8 of 1999. Both these problems are to be discussed more deeply by the author as study materials and information about the form of legal protection and benefits to the drug labeling for lawful Moslems consumers as Indonesia citizen. \ud \ud In writing this law, the author uses the technique of literary study, and then further processed by the method of juridical normative view of law as a norm that is alive and growing within the community. collecting legislation related lawful labeling and analyzing relevant provisions of which is the Law - consumer protection law number 8 of 1999 Article 8 letter (h), Law - food law number 7 of 1996 Article 34 paragraph 1, and on government regulations number 69 in 1999, Article 10. \ud \ud There are several things that can be expressed succinctly in the writing of this law, consumer rights related to Moslems Indonesia to obtain information on the form of permissible drug labeling. Laws - laws in Indonesia have not been able to accommodate and provide legal protection for Muslim consumers related business duties to include lawful label on goods production. The absence of liability provision of correct information, clear and honest about the condition of the products with lawful label on the drug seem more legitimate to protect the interests and convenience and profit for the business alone. \ud \ud The results of this writing found that lawful labeling obligation arises when business first initiative to provide lawful labeling on the goods or products included in the drug product. And lawful labeling on drugs is a very important and urgent in Indonesia since the majority of citizens of Indonesia Islamic religion. Besides the inclusion of the label is a form of lawful obligation to businessmen acting in good faith in conducting their business activities, as well as to provide correct information, clear and honest about the condition and guarantee of a good. Besides the inclusion of collateral in the form of lawful label on the medicine aims to treat and serve customers in particular Moslems properly and honestly and not discriminatory

An Examination of Strict Criminal Liability Under the Food, Drug and Cosmetic Act of 1938: Is It Time For Change?

Food and drug violations have been largely governed by a strict liability standard since the nineteenth century. Use of this standard in connection with criminal sanctions has generally been defended on the grounds that the health and welfare of the public are of such importance that it is necessary to provide members of the food and drug industry with an extra impetus to abide by the applicable food and drug regulations. Nonetheless, strict criminal liability has not been wholly successful in averting violations of food and drug regulations, as evidenced by the presence of a number of criminal cases involving food and drug industry participants. It, therefore, might be time to question the goals of the Food, Drug and Cosmetic Act of 1938, enforcement policy, and whether the use of strict criminal liability is a necessary method of achieving those goals in the current setting. This paper attempts to analyze these questions by tracing the history of strict liability in the area of food and drug law violations, discussing the common arguments in favor and against the imposition of strict liability in that context, and exploring alternative regimes given the current state of affairs