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Articles 1 - 9 of 9
Full-Text Articles in Health Law and Policy
Biosimilar Bias: A Barrier To Addressing American Drug Costs, Cynthia M. Ho
Biosimilar Bias: A Barrier To Addressing American Drug Costs, Cynthia M. Ho
Faculty Publications & Other Works
Forty percent of spiraling US drug costs are based on a mere two percent of all drugs –biologic drugs (biologics) made from living cells that are administered by injection or infusion. These costs will continue to balloon as new biologics are approved; the recently approved Alzheimer’s drug is expected to result in a 50% increase in Medicare spending and cost individuals 40% of their annual income. These drugs are expensive because they cannot be mass-produced, and their cost places important treatments for conditions such as arthritis (Humira) and cancer (Herceptin) out of reach for many Americans. Fortunately, just as there …
Open Source: The Enewsletter Of Rwu Law 09-22-2017, Roger Williams University School Of Law
Open Source: The Enewsletter Of Rwu Law 09-22-2017, Roger Williams University School Of Law
Life of the Law School (1993- )
No abstract provided.
Newsroom: Logan Quoted In Bloomberg News On Opiod Litigation 08-16-2017, Jef Feeley, Jared S. Hopkins
Newsroom: Logan Quoted In Bloomberg News On Opiod Litigation 08-16-2017, Jef Feeley, Jared S. Hopkins
Life of the Law School (1993- )
No abstract provided.
A Randomized Study Of How Physicians Interpret Research Funding Disclosures, Christopher Robertson
A Randomized Study Of How Physicians Interpret Research Funding Disclosures, Christopher Robertson
Faculty Scholarship
The effects of clinical-trial funding on the interpretation of trial results are poorly understood. We examined how such support affects physicians’ reactions to trials with a high, medium, or low level of methodologic rigor.
Regulating Compounding Pharmacies After Necc, Kevin Outterson
Regulating Compounding Pharmacies After Necc, Kevin Outterson
Faculty Scholarship
Food and Drug Administration (FDA) rules are often forged in crisis. After the 1937 sulfanilamide disaster that killed more than 100 people, Congress passed the Food, Drug, and Cosmetic Act (FDCA),requiring drugs to be safe and properly labeled. In 1962, a requirement was introduced for proof of drug efficacy through “adequate and well-controlled investigations,” partly in response to the thalidomide tragedy. Rules protecting human-research subjects owe a debt to Tuskegee and Nuremberg.
Reverse Settlements As Patent Invalidity Signals, Gregory Dolin
Reverse Settlements As Patent Invalidity Signals, Gregory Dolin
All Faculty Scholarship
Over the last decade a new type of settlements, commonly referred to as “reversed payment settlements” or simply “reverse settlements,” emerged in litigation over patents covering pharmaceutical products. What differentiates these new settlements from their traditional counterparts is that whereas traditionally, the alleged trespasser on someone else's rights pays the rights-holder to settle the litigation, in these new settlements it is the rights holder that pays the alleged trespasser. These settlements are a direct consequence of the various incentives provided by the Hatch-Waxman Act - an Act designed to increase competition between brand name and generic manufactures of pharmaceutical products. …
Higher First Amendment Hurdles For Public Health Regulation, Kevin Outterson
Higher First Amendment Hurdles For Public Health Regulation, Kevin Outterson
Faculty Scholarship
In 2007, Vermont enacted the Prescription Confidentiality Law, prohibiting pharmacies from selling “prescriber-identifiable” prescription information to data-mining companies such as IMS Health and Verispan. These companies aggregate such data and sell them to many groups, including drug companies, so when drug sales representatives visit a physician, they can know exactly what prescriptions the physician has written.
Cancer And The Constitution: Choice At Life's End, George J. Annas
Cancer And The Constitution: Choice At Life's End, George J. Annas
Faculty Scholarship
J. M. Coetzee's violent, anti-apartheid Age of Iron, a novel the Wall Street Journal termed “a fierce pageant of modern South Africa,” is written as a letter by a retired classics professor, Mrs. Curren, to her daughter, who lives in the United States. Mrs. Curren is dying of cancer, and her daughter advises her to come to the United States for treatment. She replies, “I can't afford to die in America. . . . No one can, except Americans.” Dying of cancer has been considered a “hard death” for at least a century, unproven and even quack remedies have been …
Thalidomide And The Titanic: Reconstructing The Technology Tragedies Of The Twentieth Century, George J. Annas
Thalidomide And The Titanic: Reconstructing The Technology Tragedies Of The Twentieth Century, George J. Annas
Faculty Scholarship
The Titanic has become a metaphor for the disastrous consequences of an unqualified belief in the safety and invincibility of new technology. Similarly, the thalidomide tragedy stands for all of the "monsters" that can be inadvertently or negligently created by modern medicine. Thalidomide, once banned, has returned to the center of controversy with the Food and Drug Administration's (FDA's) announcement that thalidomide will be placed on the market for the treatment of erythema nodosum leprosum, a severe dermatological complication of Hansen's disease. Although this indication is very restricted, thalidomide will be available for off-label uses once it is on the …