Food and Drug Law Journal

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...

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...

Harm reduction is an internationally recognized tobacco control strategy. E-cigarettes, being a less harmful alternative to smoking, have the potential to achieve harm reduction. Within this context, this article critiques Hong Kong’s legal regime governing e-cigarettes and the proposed prohibition of the product. It is argued that the current law is uncertain and inadequate. Although a reform of laws relating to e-cigarettes is needed, it is argued that banning the product altogether as a means to reducing the harm of tobacco use is unsupported by evidence...

Scientists have repurposed an adaptive immune system of single cell organisms to create a new type of gene-editing tool: CRISPR (clustered regularly interspaced short palindromic repeats)-Cas technology. Scientists in China have reported its use in the genome modification of non-viable human embryos. This has ignited a spirited debate about the moral, ethical, scientific, and social implications of human germline genome engineering. There have also been calls for regulations; however, FDA has yet to formally announce its oversight of clinical applications of CRISPR-Cas systems...

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.

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...

No abstract text is available yet for this article.

On May 27, 2016, the Food and Drug Administration (FDA) announced that it was adopting a new rule that requires food manufacturers to list—on the already mandated Nutrition Facts label—how many grams of sugar have been added to a food product. Many opponents have criticized this “added sugars” rule on First Amendment grounds, arguing that the rule violates the commercial speech rights of food manufacturers. Whether the rule would survive constitutional scrutiny or not is an open question because the compelled commercial speech doctrine is anything but clear...

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...

No abstract text is available yet for this article.

No abstract text is available yet for this article.

No abstract text is available yet for this article.

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...

Evolving First Amendment principles are forcing FDA and other federal regulators of medical products to rethink traditional regulatory approaches to off-label product communications. State regulators, which have actively sought injunctions restricting manufacturer communications to the four-corners of the FDA-approved product label, must additionally abide by federal preemption principles. This article reviews the application of preemption principles to off-label communications and concludes that most, if not all, state-law restraints on off-label communications are preempted by federal law...

No abstract text is available yet for this article.

No abstract text is available yet for this article.

No abstract text is available yet for this article.

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...

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...

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"...