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Articles 1 - 9 of 9
Full-Text Articles in Law
State 'Right To Try' Acts: A Good Start, But A Federal Act Is Necessary, Ellen A. Black
State 'Right To Try' Acts: A Good Start, But A Federal Act Is Necessary, Ellen A. Black
Law Faculty Scholarship
In an effort to help terminally ill patients bypass the FDA's arduous, time-consuming approval process and have quicker access to potentially life-saving drugs, states across the country have passed "right to try" acts. These state acts allow a terminally ill patient the right to access an investigational drug that has completed initial safety testing, known as Phase I, but that has not been approved by the FDA. The reasoning behind these acts is that terminally ill patients, with the guidance and counsel of their physicians, should have the choice whether to pursue an unapproved drug, rather than placing their fate …
Keep Out Fda: Food Manufacturers' Ability To Effectively Self-Regulate Front-Of-Package Food Labeling, Ellen A. Black
Keep Out Fda: Food Manufacturers' Ability To Effectively Self-Regulate Front-Of-Package Food Labeling, Ellen A. Black
Law Faculty Scholarship
The headlines on any given day claim that the American "obesity epidemic" continues to worsen.' According to these headlines, Americans, both adults and children, are increasingly becoming more obese, are more likely to be diagnosed with diabetes, and will likely prematurely die due to this preventable disease. Numerous private industries, as well as the government, seek to rescue Americans from this crisis. As the obesity epidemic debate intensifies, the call for more government regulation correspondingly grows. There are critics, however, who question the legitimacy of this epidemic and the need for more regulation. For example, some well-known scholars opine that …
Dietary Supplement Labeling: Cognitive Biases, Market Manipulation & Consumer Choice, Michael Mccann
Dietary Supplement Labeling: Cognitive Biases, Market Manipulation & Consumer Choice, Michael Mccann
Law Faculty Scholarship
There exists increasing concern that the Dietary Supplements Health and Education Act (DSHEA) has proven ineffective. Much of the concern regards the disparity in legislative treatment between dietary supplements, foods, and pharmaceutical drugs. Namely, while pharmaceutical drugs must undergo years of costly pre-market testing, most supplements, like foods, can immediately enter the market, and only after repeated instances of adverse reactions can the Food and Drug Administration (FDA) remove them. Such a framework appears to belie both consumer expectations and marketing strategies, as supplements tend to be most perceived for their apparent medicinal qualities. This philosophy of waiting for a …
Nudging The Fda, W. Nicholson Price Ii, I. Glenn Cohen
Nudging The Fda, W. Nicholson Price Ii, I. Glenn Cohen
Law Faculty Scholarship
[Excerpt] "The FDA’s regulation of drugs is frequently the subject of policy debate, with arguments falling into two camps. On the one hand, a libertarian view of patients and the health care system holds high the value of consumer choice. Patients should get all the information and the drugs they want; the FDA should do what it can to enforce some basic standards but should otherwise get out of the way. On the other hand, a paternalist view values the FDA’s role as an expert agency standing between patients and a set of potentially dangerous drugs and potentially unscrupulous or …
Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii
Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii
Law Faculty Scholarship
Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …
Superweeds And Suspect Seeds: Does The Genetically-Engineered Crop Deregulation Process Put American Agriculture At Risk, Margaret Sova Mccabe
Superweeds And Suspect Seeds: Does The Genetically-Engineered Crop Deregulation Process Put American Agriculture At Risk, Margaret Sova Mccabe
Law Faculty Scholarship
The federal government’s regulatory approach to genetically engineered (GE) crops, known as “The Framework”, is now twenty-five years old. Despite two and half decades of a consistent regulatory regime, GE crop and food regulation remains controversial. This article suggests that regulatory science and its tenets of independence, transparency, and public science should guide reforms of The Framework so that it is an efficient and reliable regulatory system. The article has four parts: 1) it provides a brief overview of the history of GE crop regulation; 2)it describes the key attributes of The Framework and related regulatory documents, with particular focus …
Balancing Consumer Protection And Scientific Integrity In The Face Of Uncertainty: The Example Of Gluten-Free Foods, Margaret Sova Mccabe
Balancing Consumer Protection And Scientific Integrity In The Face Of Uncertainty: The Example Of Gluten-Free Foods, Margaret Sova Mccabe
Law Faculty Scholarship
In 2009, gluten-free foods were not only "hot" in the marketplace, several countries, including the United States, continued efforts to define gluten-free and appropriate labeling parameters. The regulatory process illuminates how difficult regulations based on safe scientific thresholds can be for regulators, manufacturers and consumers. This article analyzes the gluten-free regulatory landscape, challenges to defining a safe gluten threshold, and how consumers might need more label information beyond the term "gluten-free." The article includes an overview of international gluten-free regulations, the Food and Drug Administration (FDA) rulemaking process, and issues for consumers.
Got Controversy - Milk Does, Margaret Sova Mccabe
Got Controversy - Milk Does, Margaret Sova Mccabe
Law Faculty Scholarship
This article analyzes ongoing controversy over how to best label rBST-free milk. Recombinant bovine somatotropin is a genetically engineered drug administered by some farmers to their dairy herds to increase milk production. FDA first approved its use in 1994, despite great controversy. The FDA also issued labeling guidelines that allowed voluntary disclosure of rBST-free milk, so long as it carried the disclaimer that no difference could be detected between milk produced with rBST and rBST-free. The controversy continues today as consumers express a preference for rBST-free milk and many rBST-free producers label their milk this way. "Conventional" milk (with rBST) …
Informed Consent And The Investigational Use Of Medical Devices: A Comparison Of Common Law Duties With Those Imposed On Researchers Under Section 520(G) Of The Medical Device Amendments Of 1976, Thomas G. Field Jr., Dominic Piacenza
Informed Consent And The Investigational Use Of Medical Devices: A Comparison Of Common Law Duties With Those Imposed On Researchers Under Section 520(G) Of The Medical Device Amendments Of 1976, Thomas G. Field Jr., Dominic Piacenza
Law Faculty Scholarship
This paper will deal with with exemption granted [under the Medical Device Amendments Act of 1976] for the investigational use of devices subject to premarket testing, and more particularly, with the obligation of an investigator seeking such exemption to secure an informed consent agreement from human subjects (or their representatives) under § 520(g)(3)(D) of the Act. It will also consider the relationship between the statutory obligation and that which might be imposed by the common law of negligence.