Food and drug law journal最新文献

Facing a tension between the increasing use of genetically engineered or modified food and consumer concerns over the risks associated with GMOs, China has established a GM food labeling regime through regulations-known as Agro-GMO regulations-to protect consumers' right to know. However, the design and enforcement of this GM food labeling regime is problematic. As a result, the labeling regime is ineffective and inconsistent, leaving consumers' rights unprotected. As the recently amended Food Safety Law in China requires GM food labeling for the first time, this article argues that China should replace the current Agro-GMO food labeling scheme with a special regulatory scheme. A comparative analysis of the GM food labeling systems in the European Union and United States, coupled with a rigorous examination of the problems and barriers of GM food labeling in China, sets a solid foundation by which to propose changes to incorporate into a special regulatory scheme. To this end, this article engages in such an analysis and recommends practical steps to guide the enactment of a special regulatory scheme. The recommendations comport with China's unique legal and political culture, but also could be used by other national regulatory regimes who permit use of GM food while also being committed to improving consumers' right to know.

The regulation of food, drugs, and controlled substances in this country is exceedingly complex. Local, state, and federal regulation coexist, and common law remedies supplement positive law. Strata of regulation are necessary because patterns of production and consumption vary by region and demographic, while federal regulation provides regulatory uniformity across the United States. As localities struggle to sustain autonomy in response to local preference while working within a centralized system, and federal agencies struggle to maintain regulatory uniformity to foster a national marketplace, we see interaction and friction between regulatory spheres. While this friction usually becomes apparent through a lens of adversity, it is also a space of foment for policy change and democratic engagement. In this Paper I explore this productive space by looking at several recent instances of action by states in food, dietary supplements, and controlled substances regulation that highlight this friction. An analysis of these actions and the challenges to them provides an opportunity to view the interaction between different levels of regulatory authority and to discuss implications of the judicial review of these enactments. We see complex and shifting alliances working to change policy, and we see benefits in the push and pull caused by these actions.

Government-mandated labeling requirements have a long history, and are used extensively by FDA in regulating the industries under its jurisdiction. All such requirements can be characterized as a form of “compelled speech,” opening the door to First Amendment challenges. And some of these challenges, depending on the nature of the labeling requirement, have even been successful. Under Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, regulations that compel disclosure of information will, in many cases, merit only very limited First Amendment scrutiny—less, even, than most other regulations of commercial speech, which receive a type of “intermediate scrutiny.” The labeling requirement that can best avoid or overcome a First Amendment challenge, therefore, will follow the example of the regulation described in Zauderer. For example, Zauderer applied its lower scrutiny by noting that the compelled speech at issue was a disclosure of “purely factual and uncontroversial information.” Conversely, a successful First Amendment challenge to a labeling requirement will often involve an argument that the labeling requirement is outside the scope of what the Zauderer Court contemplated: so, for example, one may argue that a compelled disclosure is either “not factual” or else “controversial,” putting it beyond Zauderer’s reach. After briefly reviewing the major Supreme Court cases that establish the levels of scrutiny for commercial speech and compelled disclosures, the paper will discuss how the various elements of Zauderer have been analyzed by several lower courts, and how some courts have distinguished Zauderer in the context of labeling and other mandatory disclosure laws. In particular, the paper will focus on cases involving First Amendment challenges to food, tobacco, and drug labeling requirements—some successful, some not, and some ongoing—including cases challenging FDA, USDA, and state-level labeling requirements. The decided cases do not all agree on how to understand the elements of Zauderer—for example, must a disclosure be factually controversial to fall outside of Zauderer’s limited review, or may it be factually unquestionable but relating to a controversial topic? What role, if any, should public acceptance, knowledge, and history play? What sorts of interests may the government invoke to justify a labeling requirement? Although some courts have taken (or at least hinted at) strict limits on the meaning of Zauderer, most courts have read Zauderer as applying somewhat more expansively to circumstances beyond its facts. The paper concludes that generally, courts have read Zauderer more expansively in part because such a reading is consistent with existing, familiar labeling requirements, and a narrow reading of Zauderer limited to its facts would rest on a slippery slope to abolishing many accepted and historically unquestioned labeling requirements. Any future attempts to expand judicial review of labeling requirem

This article is a history of the policy positions and legal interpretations adopted by the Public Health Service (PHS) under the 1902 Biologics Control Act. PHS generally interpreted the scope of the Act narrowly because it lacked authority to deny marketing licenses for ineffective biologics and wanted to minimize the number of worthless drugs with the imprimatur of a governmental license. In addition, PHS implemented important regulatory strategies not expressly authorized by the Act.

Finding the intent to defraud or mislead for the conviction of felony fraud could be very tricky in the context of food regulation. As compared to the split among the US federal circuit courts on the interpretation of intent, Taiwan courts looked into the extent of harm to the victim to determine whether the defendant should be convicted of felony fraud. In order to limit the scope of felony liability, Taiwanese law requires an additional showing of the extent of harm to the victim. Recently, courts in Taiwan further expanded the scope of the statutory language, “harmful to human health,” to include potential harm as demonstrated by animal studies. This approach provides courts in other jurisdiction with an alternative aggravating factor to assess criminal liability in nondisclosure cases arising out of non-compliance with food law.

This article addresses the problem of restricted access to industry-sponsored clinical trial data. In particular, it analyzes the intersection of the competing claims that mandatory disclosure of pharmaceutical test data impedes drug sponsors’ innovation incentives and that access facilitates new drug development. These claims are characterized in terms of public-good and common-resource dilemmas. The analysis finds confidentiality protection of primary research data plays an ambiguous role. While secrecy, as such, does not solve the public-good problem in pharmaceutical innovation (in the presence of regulatory instruments that protect the originator drug against generic competition), it is likely to exacerbate the common-resource problem, in view of data as a source of scientific knowledge. It is argued that the claim by the research-based industry that disclosure of clinical data impedes innovation incentives is misplaced and should not be leveraged against pro-access policies. While much attention has been paid to the problem of appropriability of drug R&D investment, this analysis highlights another consequence resulting from the private provision of clinical trials, i.e., factual confidentiality and possession of data by drug sponsors. The associated social costs are qualified in terms of internalized knowledge externalities. Since, in a competitive environment, companies are unlikely to change the strategy of non-sharing of primary data, the resulting economic inefficiencies at the sector level call for regulatory intervention. To reconcile the competing policy objectives, it is proposed that the rules of access should be designed in such a way that third-party use of primary data does not interfere with protection against generic competition. At the same time, the long-term collective benefit can be maximized when the “cooperative choice” (i.e., when everyone shares data) becomes the “dominant strategy.” This can be achieved only when access is not subject to the authorization of the initial trial sponsors, and when primary data is aggregated, refined, and managed on the collective basis.

The pharmaceutical industry may be losing the battle of public opinion, but it has won important victories in the war over First Amendment commercial speech. In December 2012, the Second Circuit held in United States v. Caronia that the misbranding provisions of the Food, Drug, and Cosmetic Act could not prohibit a sales representative’s truthful statements promoting off-label uses of his company’s products. At the same time, a parallel area of pharmaceutical litigation has curiously remained almost untouched: Civil False Claims Act (FCA) settlements based on allegations that manufacturers caused false claims to be submitted by promoting their drugs off-label. Yet logic suggests that if manufacturers have a First Amendment right to discuss off-label drug uses, claims submitted when drugs are prescribed for those uses should not be considered false. This inconsistency is problematic and likely unsustainable. If manufacturers are emboldened by Caronia to challenge off-label FCA suits, the focus likely will be on the truth of the company’s statements. Despite its name, however, FCA is unsuited to addressing disputes over medical and scientific data. To maintain the integrity of this key anti-fraud enforcement tool, it is crucial to separate the truth of the claims for payment from the truth of the manufacturer’s underlying scientific statements. Because Medicare and Medicaid coverage determinations rely heavily on FDA approval, however, those issues are inextricably intertwined. This article explores why off-label promotion has been treated inconsistently in these contexts, and how this trend highlights the limitations of the FCA as a panacea for health care fraud.