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The New Food Safety, Margot J. Pollans, Emily M. Broad Leib
The New Food Safety, Margot J. Pollans, Emily M. Broad Leib
Elisabeth Haub School of Law Faculty Publications
A safe food supply is essential for a healthy society. Our food system is replete with different types of risk, yet food safety is often narrowly understood as encompassing only foodborne illness and other risks related directly to food ingestion. This Article argues for a more comprehensive definition of food safety, one that includes not just acute, ingestion-related risks, but also whole-diet cumulative ingestion risks, and cradle-to-grave risks of food production and disposal. This broader definition, which we call “Food System Safety,” draws under the header of food safety a variety of historically siloed, and under-regulated, food system issues including …
Access Before Evidence And The Price Of The Fda's New Drug Authorities, Erika Lietzan
Access Before Evidence And The Price Of The Fda's New Drug Authorities, Erika Lietzan
Faculty Publications
Sometimes drug innovation seems to happen in reverse. Patients enjoy a treatment for years even though the treatment has not been approved by the FDA or proven safe and effective to the FDA's standards. (Sometimes this happens because the FDA has declined to take enforcement action.) The agency encourages companies to perform the work necessary to satisfy the United States "gold standard" for new drug approval, however, by promising exclusivity in the marketplace. When a company does this work, at considerable expense, the results are predictable. The new drug is expensive, and patients and payers (and sometimes policymakers) are outraged. …
The Surprising Reach Of Fda Regulation Of Cannabis, Even After Descheduling, Erika Lietzan, Sean M. O'Connor
The Surprising Reach Of Fda Regulation Of Cannabis, Even After Descheduling, Erika Lietzan, Sean M. O'Connor
Faculty Publications
As more states legalize cannabis, the push to "deschedule" it from the Controlled Substances Act is gaining momentum. At the same time, the Food and Drug Administration (FDA) recently approved the first conventional drug containing a cannabinoid derived from cannabis - cannabidiol (CBD) for two rare seizure disorders. This would all seem to bode well for proponents of full federal legalization of medical cannabis. But some traditional providers are wary of drug companies pulling medical cannabis into the regular small molecule drug development system. The FDA's focus on precise analytical characterization and on individual active and inactive ingredients may be …
Direct-To-Consumer Ads Are Misleading: Concise Statements Of Effectiveness Should Be Required, Robert A. Bohrer
Direct-To-Consumer Ads Are Misleading: Concise Statements Of Effectiveness Should Be Required, Robert A. Bohrer
Faculty Scholarship
Direct-to-consumer (DTC) advertising of prescription pharmaceuticals has been the subject of much criticism and the issue has become even more pressing with the Trump administration’s proposal to require the disclosure of prices in DTC ads. In this article I argue that a more powerful approach to the problem of DTC ads would require the disclosure of the effectiveness of the advertised drugs, at least as found in the clinical trials submitted for FDA approval. To support the need for an effectiveness disclosure, I describe the problem of DTC ads and examine representative ads to illustrate the potential of such ads …
Drug Prices, Dying Patients, And The Pharmaceutical Marketplace: A New Conditional Approval Pathway For Critical Unmet Medical Needs, Robert A. Bohrer
Drug Prices, Dying Patients, And The Pharmaceutical Marketplace: A New Conditional Approval Pathway For Critical Unmet Medical Needs, Robert A. Bohrer
Faculty Scholarship
Prescription drugs have been a major topic in the news for much of the past year. There are two issues which appear often: first, the very high prices of new drugs, particularly the "specialty" drugs developed for serious diseases; and second, the time required for FDA approval in relation to the perceived need for earlier access to new therapies for critically ill patients. Much less in the news, but lurking behind both issues, is the need for better information for physicians and patients to use in making decisions about prescribing and taking drugs, and for insurance companies and the government …
The "Evergreening" Metaphor In Intellectual Property Scholarship, Erika Lietzan
The "Evergreening" Metaphor In Intellectual Property Scholarship, Erika Lietzan
Faculty Publications
This article is a plea for changes in the scholarly dialogue about "evergreening" by drug companies. Allegations that drug companies engage in "evergreening" are pervasive in legal scholarship, economic scholarship, medical and health policy scholarship, and policy writing, and they have prompted significant policymaking proposals. This Article was motivated by concern that the metaphor has not been fully explained and that policymaking in response might therefore be premature. It canvasses and assesses the scholarly literature-more than 300 articles discussing or mentioning "evergreening." It catalogues the definitions, the examples, and the empirical studies. Scholars use the term when describing certain actions …
Drugs' Other Side Effects, Craig J. Konnoth
Drugs' Other Side Effects, Craig J. Konnoth
Publications
Drugs often induce unintended, adverse physiological reactions in those that take them—what we commonly refer to as “side-effects.” However, drugs can produce other, broader, unintended, even non-physiological harms. For example, some argue that taking Truvada, a drug that prevents HIV transmission, increases promiscuity and decreases condom use. Expensive Hepatitis C treatments threaten to bankrupt state Medicaid programs. BiDil, which purported to treat heart conditions for self-identified African-Americans, has been criticized for reifying racial categories. Although the Food & Drug Administration (“FDA”) has broad discretion under the Food, Drugs, and Cosmetics Act (“FDCA”) to regulate drugs, it generally considers only traditional …
Life, Liberty, [And The Pursuit Of Happiness]: Medical Marijuana Regulation In Historical Context, Lewis Grossman
Life, Liberty, [And The Pursuit Of Happiness]: Medical Marijuana Regulation In Historical Context, Lewis Grossman
Articles in Law Reviews & Other Academic Journals
The struggle for access to medical marijuana differs from most other battles for therapeutic freedom in American history because marijuana also has a popular, though controversial, nontherapeutic use—delivery of a recreational high. After considering struggles over the medical use of alcohol during prohibition as a precedent, this chapter relates the history of medical marijuana use and regulation in the United States. The bulk of the chapter focuses on the medical marijuana movement from the 1970s to present. This campaign has been one of the prime examples of a successful extrajudicial social movement for freedom of therapeutic choice. With the exception …