Law Commons^™

Will Courts Allow States To Regulate Drug Prices?, Christopher Robertson

Faculty Scholarship

Pharmaceuticals are consuming increasingly large portions of U.S. state budgets, and high prices are preventing patients from getting, and adhering to, essential medicines. In mid-May 2018, President Donald Trump announced a heavily hyped but relatively modest federal plan to bring down drug prices. Meanwhile, several states are moving forward with their own solutions, and Maryland’s approach is particularly ambitious. In 2017, responding to notorious cases such as the 5000% increase in the cost of Daraprim (pyrimethamine) and the 10-fold increase in the cost of EpiPens (epinephrine auto-injectors), Maryland enacted a statute that prohibits manufacturers from “price gouging” on any “essential …

On Drugs: Preemption, Presumption, And Remedy, Elizabeth Mccuskey

Faculty Scholarship

This essay explores the role of litigation in drug safety regulation and the role of drug safety regulation in litigation, exemplified by the 2017 National Health Law Moot Court Problem. Using the example of failure-to-update claims against generic drug manufacturers, this essay argues that pharmaceutical preemption doctrine would benefit from a tailored application of the presumption against preemption. It proposes a presumption that Congress does not intend to displace historic state remedies for injury without clearly saying so, focusing on the role of remedy to account for the evolving overlap in federal and state police powers over health and to …

Progress In The Fight Against Multidrug Resistant Bacteria?: A Review Of Fda-Approved Antibiotics 2010-2015, Kevin Outterson

Faculty Scholarship

A weak antibiotic pipeline and the increase in drug-resistant pathogens have led to calls for more new antibiotics. Eight new antibiotics were approved by the U.S. Food and Drug Administration (FDA) between January 2010 and December 2015: ceftaroline, fidaxomicin, bedaquiline, dalbavancin, tedizolid, oritavancin, ceftolozane-tazobactam, and ceftazidime-avibactam. This study evaluates the development course and pivotal trials of these antibiotics for their innovativeness, development process, documented patient outcomes, and cost. Data sources were FDA approval packages and databases (January 2010 to December 2015); the Red Book (Truven Health Analytics); Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (FDA); and supplementary information …

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.

With Child, Without Rights?: Restoring A Pregnant Woman's Right To Refuse Medical Treatment Through The Hiv Lens, Michael Ulrich

Faculty Scholarship

In Doe v. Division of Youth & Family Services , a hospital employee sought state intervention when an HIV-positive woman refused to comply with treatment recommendations during her pregnancy to drastically reduce the chances of mother-to-child-transmission (MTCT), eventually triggering a lawsuit against the hospital. With an increase in the number of HIV-positive women becoming pregnant and the court avoiding constitutional analysis of the woman’s right to refuse medical treatment, there is a clear void where legal analysis is surely needed. This Article fills this void for the inevitable case where an HIV-positive pregnant woman’s right to refuse medical treatment is …

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.

Enhancing The Fighting Force: Medical Research On American Soldiers, Catherine L. Annas, George J. Annas

Faculty Scholarship

During President Barack Obama's first primetime press conference, reporters asked primarily about the state of the economy and terrorism. Wedged between questions on these two vital issues was a query from the Washington Post's Michael Fletcher:

Question: What is your reaction to Alex Rodriguez's admission that he used steroids as a member of the Texas Rangers?

Obama: You know, I think it's depressing news.... And if you're a fan of Major League Baseball, I think it - it tarnishes an entire era, to some degree. And it's unfortunate, because I think there are a lot of ballplayers who played it …

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 …

Fair Followers: Expanding Access To Generic Pharmaceuticals For Low- And Medium-Income Populations, Kevin Outterson

Faculty Scholarship

U.S. trade offi cials frequently employ the rhetoric of free riding and piracy when discussing intellectual property (IP) rights for medicines (Drahos with Braithwaite 2002; Benson 2005). The gentler term free rider is applied when developed country governments (OECD) use monopsony power to negotiate price discounts on patented pharmaceuticals (Outterson 2004, 2005b; U.S. Department of Commerce 2004; PhRMA 2005). Poorer governments usually lack suffi cient market power as a purchaser to negotiate discounts for their low- and middle-income populations. In these cases, governments and patients may resort to unlicensed generic drugs and compulsory licensing. In response, U.S. trade offi cials …

Forcible Medication For Courtroom Competence: The Case Of Charles Sell, George J. Annas

Faculty Scholarship

The right to refuse treatment is firmly recognized in U.S. law. Competent persons have the legal right to refuse treatment, even life-sustaining treatment, and incompetent patients can also refuse treatment through an advance directive, by naming a health care agent to make decisions for them or by having a person who knows their wishes express them.

Death By Prescription, George J. Annas

Faculty Scholarship

Society and physicians in the United States remain unable to accept death and thus unable to deal with the physical, psychological, and spiritual approach of death. The hour of death itself “is commonly tranquil,” but “the serenity is usually bought at a fearful price -- and the price is the process by which we reach that point” -- a process that has been described as “a purgatory that may last for weeks.” Suicide has been seen as a rational way to avoid that purgatory, especially as a response to end-stage cancer and AIDS, and proposals to “legalize” physician-assisted suicide in …