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Articles 1 - 30 of 30
Full-Text Articles in Law
Researching Marijuana Law, Seth Quidachay-Swan
Researching Marijuana Law, Seth Quidachay-Swan
Law Librarian Scholarship
This article provides a brief overview of the current legal framework governing the regulation of marijuana at the federal and state levels in the United States. It also provides an overview of the state of Michigan’s current regulatory framework and resources for attorneys interested in learning more about marijuana regulation.
Importing Prescription Drugs From Canada — Legal And Practical Problems With The Trump Administration's Proposal, Rachel E. Sachs, Nicholas Bagley
Importing Prescription Drugs From Canada — Legal And Practical Problems With The Trump Administration's Proposal, Rachel E. Sachs, Nicholas Bagley
Articles
As Americans report ever-growing difficulty affording their prescription drugs, President Donald Trump has come under increasing pressure to act. To date, the Trump administration has attempted to advance a number of policy initiatives by means of executive action, but it has not yet adopted a program that would meaningfully assist patients. Most recently, the administration proposed a rule that, if finalized, would allow states to develop programs to import lower-priced prescription drugs from Canada, with the intent of reducing spending on drugs by U.S. patients and states and increasing access for patients.
'Of Sound Mind And Body': A Call For Universal Drug Screening For All Newborns, Frank Vandervort, Vincent J. Palusci
'Of Sound Mind And Body': A Call For Universal Drug Screening For All Newborns, Frank Vandervort, Vincent J. Palusci
Book Chapters
Substance abuse is a major medical and social problem. Estimates suggest that each year some 15 percent of the 4 million babies born in the United States are exposed to drugs or alcohol. Research demonstrates that exposure to these substances is harmful to the children in both the short term and across their developmental trajectory. This chapter summarizes the harms that might result from such prenatal exposure and considers the ways that both federal and state law respond to this. The chapter argues for universal drug testing of newborns in an effort to ascertain whether they have been prenatally exposed …
Prenatal Drug Exposure As Aggravated Circumstances, Frank E. Vandervort
Prenatal Drug Exposure As Aggravated Circumstances, Frank E. Vandervort
Articles
In Michigan, "a child has a legal right to begin life with sound mind and body." Yet the family court may not assert Juvenile Code jurisdiction until after birth. In re Baby X addressed the question of whether a parent's prenatal conduct may form the basis for jurisdiction upon birth. It held that a mother's drug use during pregnancy is neglect, allowing the court to assert jurisdiction immediately upon the child's birth. In deciding Baby X, the Court specifically reserved the question of whether parental drug use during pregnancy might be sufficient to permanently deprive a parent of custody. …
Response To 'Reverse Al Capone-Ism' And The Tax Treatment Of Marijuana Businesses, Douglas A. Kahn, Howard J. Bromberg
Response To 'Reverse Al Capone-Ism' And The Tax Treatment Of Marijuana Businesses, Douglas A. Kahn, Howard J. Bromberg
Other Publications
Mr. Silverberg’s comment stresses that the proponents of the legalization of marijuana have not been able to convince Congress to legalize it, and so it is appropriate for Congress to penalize trafficking in that drug. Apparently, he sees our contention that the penalty adopted in I.R.C. § 280E is irrational and contravenes established punitive jurisprudence as a backdoor attempt to accomplish indirectly, by weakening the penalties on the marijuana businesses, what has not been able to be accomplished by those seeking its federal legalization. That was not the motive for our proposal and is not a fair reading of our …
Response To Dude, Where's My Deduction?, Douglas A. Kahn, Howard J. Bromberg
Response To Dude, Where's My Deduction?, Douglas A. Kahn, Howard J. Bromberg
Other Publications
Mr. Pullin’s thesis is that marijuana should be excluded from § 280E when it is operated legally under state law. However, his preferred solution is that the federal government remove marijuana from Schedules I and II of the Controlled Substances Act of 1970 (CSA), thereby legalizing it for federal law purposes. Either action would exclude the marijuana business from § 280E.
Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs
Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs
Articles
Throughout the United States, escalating drug prices are putting immense pressure on state budgets. Several states are looking for ways to push back. Last year, Massachusetts asked the Trump administration for a waiver that would, among other things, allow its Medicaid program to decline to cover costly drugs for which there is limited or inadequate evidence of clinical efficacy. By credibly threatening to exclude such drugs from coverage, Massachusetts hoped to extract price concessions and constrain the fastest-growing part of its Medicaid budget.
Drug Approval In A Learning Health System, W. Nicholson Price
Drug Approval In A Learning Health System, W. Nicholson Price
Articles
The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …
Innovative Contracting For Pharmaceuticals And Medicaid’S Best-Price Rule, Nicholas Bagley
Innovative Contracting For Pharmaceuticals And Medicaid’S Best-Price Rule, Nicholas Bagley
Articles
In recent years, drug manufacturers and private payers have expressed interest in novel pricing models that more closely link a drug’s price to its value. Indication-based pricing, outcome-based pricing, drug licenses, and drug mortgages have all been discussed as alternatives to paying strictly for volume. Manufacturers and payers have complained, however, that Medicaid’s “best-price rule” inhibits their ability to enter into these newpricing arrangements. This article examines the best-price rule and assesses to what extent, if any, it might frustrate the goal of paying for value. We conclude that the best-price rule is not as serious a problem as it …
Tax Treatment Of A Marijuana Business, Douglas A. Kahn, Howard Bromberg
Tax Treatment Of A Marijuana Business, Douglas A. Kahn, Howard Bromberg
Articles
Currently, twenty-eight states and the District of Columbia allow the use of marijuana for medical purposes and permit the conduct of a business marketing of marijuana for that purpose. Eight of those states and the District of Columbia permit the recreational use of marijuana. There is reason to believe that more states will decriminalize the marketing of marijuana. However, marijuana is listed in Schedule 1 of the federal Controlled Substances Act of 1970 (CSA) which makes it illegal under federal law to manufacture or distribute marijuana even when it is legal to do so under local state law. In a …
A Liberal Dilemma: Respecting Autonomy While Also Protecting Inchoate Children From Prenatal Substance Abuse., Andrew J. Weisberg, Frank E. Vandervort
A Liberal Dilemma: Respecting Autonomy While Also Protecting Inchoate Children From Prenatal Substance Abuse., Andrew J. Weisberg, Frank E. Vandervort
Articles
Substance abuse is a significant social problem in America. It is estimated that some eighteen million Americans have an alcohol abuse problem and that almost five million have a drug abuse problem. According to the National Institute on Drug Abuse, substance abuse costs some $700 billion per year Substance abuse is a major contributor to child maltreatment. It is estimated that between one- and two-thirds of cases in which children enter foster care are linked to parental substance abuse. Unfortunately, this may be an underestimate as recent research suggests that many cases, particularly cases in which children have been exposed …
Introducing Marijuana Law Into The Legal Writing Curriculum, Howard Bromberg, Mark K. Osbeck
Introducing Marijuana Law Into The Legal Writing Curriculum, Howard Bromberg, Mark K. Osbeck
Articles
Interest in marijuana law continues to grow, due in large part to the complicated and rapidly evolving landscape of marijuana laws in the United States. Nearly every day, newspapers report on new or proposed legislation and the legal controversies that have arisen with regard to this evolving landscape. There are now several marijuana-law blogs on the Internet, Congress is considering sweeping legislation that would essentially grant significant deference to the individual states, and public opinion continues to move in favor of increased legalization. For the last two years, Newsweek magazine has published special editions devoted exclusively to marijuana law and …
Actavis, The Reverse Payment Fallacy, And The Continuing Need For Regulatory Solutions, Daniel A. Crane
Actavis, The Reverse Payment Fallacy, And The Continuing Need For Regulatory Solutions, Daniel A. Crane
Articles
The Actavis decision punted more than it decided. Although narrowing the range of possible outcomes by rejecting the legal rules at the extremes and opting for a rule of reason middle ground, the opinion failed to grapple with the most challenging issues of regulatory policy raised by pharmaceutical patent settlements. In particular, it failed to clearly delineate the social costs of permitting and disallowing patent settlements, avoided grappling with the crucial issues of patent validity and infringement, and erroneously focused on “reverse payments” as a distinctive antitrust problem when equally or more anticompetitive settlements can be crafted without reverse payments. …
Prometheus Rebound: Diagnostics, Nature, And Mathematical Algorithms, Rebecca S. Eisenberg
Prometheus Rebound: Diagnostics, Nature, And Mathematical Algorithms, Rebecca S. Eisenberg
Articles
The Supreme Court’s decision last Term in Mayo v. Prometheus left considerable uncertainty as to the boundaries of patentable subject matter for molecular diagnostic inventions. First, the Court took an expansive approach to what counts as an unpatentable natural law by applying that term to the relationship set forth in the challenged patent between a patient’s levels of a drug metabolite and the indication of a need to adjust the patient’s drug dosage. And second, in evaluating whether the patent claims add enough to this unpatentable natural law to be patent eligible, the Court did not consult precedents concerning the …
Patents And Regulatory Exclusivity, Rebecca S. Eisenberg
Patents And Regulatory Exclusivity, Rebecca S. Eisenberg
Book Chapters
This article reexamines the sources of exclusivity for drugs, considers their limitations, and evaluates exclusivity under the new biologics legislation in light of these limitations. The current overlapping legal protections for exclusivity in the pharmaceutical marketplace reflect a series of political compromises, repeatedly renegotiated to correct for unintended consequences in the previous version of the rules. Patents and patent challenges play a central role in this system of protection, and many of the patents at stake are ultimately held invalid in litigation. It is not easy to untangle a complex legal regime that allocates billions of dollars of profits. But …
"Per Se Illegality For Reverse Payment Settlements?" Review Of "Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Daniel A. Crane
"Per Se Illegality For Reverse Payment Settlements?" Review Of "Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Daniel A. Crane
Reviews
Congratulations to Mike on a very fine book. I will confine my comments to Mike's chapter on patent settlements (Chapter 15), which I understand will also be coming out as an article in the Michigan Law Review. Patent settlements involving "reverse payments" are a huge topic on which I and many others have spilled much ink already. Representative Bobby Rush (President Obama's erstwhile nemesis from Chicago's South Side) has just introduced legislation that would ban reverse payments.' I will not regurgitate my entire spiel on patent settlements here, but instead just try to highlight my essential disagreement with Mike …
Two Masters, Carl E. Schneider
Two Masters, Carl E. Schneider
Articles
American government rests on the principle of distrust of government. Not only is power within the federal government checked and balanced. Power is divided between the federal government and the state governments. So what if a state law conflicts with a federal law? The Constitution says that the "Constitution, and the Laws of the United States ... shall be the supreme Law of the Land; ... any Thing in the ... Laws of any State to the Contrary notwithstanding." Sometimes the conflict between federal and state law is obvious and the Supremacy Clause is easily applied. But sometimes ...
Constitutional Flaw?, Carl E. Schneider
Constitutional Flaw?, Carl E. Schneider
Articles
Do terminally ill patients have a constitutional right "to decide, without FDA interference, whether to assume the risks of using potentially life-saving investigational drugs that the FDA has yet to approve for commercial marketing, but that the FDA has determined, after Phase I clinical human trials, are safe enough for further testing"? In Abigail Alliance for Better Access to Developmental Drugs v. McClellan, the United States District Court for the District of Columbia said "no." In Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, a panel (three judges) of the United States Court of Appeals …
Jesting Pilate, Carl E. Schneider
Jesting Pilate, Carl E. Schneider
Articles
I have two goals this month. First, to examine a case that's in the news. Second, to counsel skepticism in reading news accounts of cases. Recently, I was talking with an admirable scholar. He said that transplant surgeons sometimes kill potential donors to obtain their organs efficiently. He added, "This isn't just an urban legend - there's a real case in California." A little research turned up California v. Roozrokh. A little Googling found stories from several reputable news sources. Their headlines indeed intimated that a transplant surgeon had tried to kill a patient to get transplantable organs. CNN.com: …
Pharma's Nonobvious Problem, Rebecca S. Eisenberg
Pharma's Nonobvious Problem, Rebecca S. Eisenberg
Articles
This Article considers the effect of the recent decision of the U.S. Supreme Court in KSR International Co. v. Teleflex, Inc. on the nonobviousness standard for patentability as applied to pharmaceutical patents. By calling for an expansive and flexible analysis and disapproving of the use of rigid formulas in evaluating an invention for obviousness, KSR may appear to make it easier for generic competitors to challenge the validity of drug patents. But an examination of the Federal Circuit's nonobviousness jurisprudence in the context of such challenges reveals that the Federal Circuit has been employing all along the sort of flexible …
Drugged, Carl E. Schneider
Drugged, Carl E. Schneider
Articles
The Supreme Court's recent decision in Gonzales v. Oregon, like its decision last year in Gonzales v. Raich (the "medical marijuana" case), again raises questions about the bioethical consequences of the Controlled Substances Act. When, in 1970, Congress passed that act, it placed problematic drugs in one of five "schedules," and it authorized the U.S. attorney general to add or subtract drugs from the schedules. Drugs in schedule II have both a medical use and a high potential for abuse. Doctors may prescribe such drugs if they "obtain from the Attorney General a registration issued in accordance with the …
The (Legal) Pains Of Vioxx: Why Product Liability Can Make Products More Dangerous, Omri Ben-Shahar
The (Legal) Pains Of Vioxx: Why Product Liability Can Make Products More Dangerous, Omri Ben-Shahar
Articles
Comparing the experience of Vioxx and Celebrex leads Omri Ben-Shahar to think that stiff product liability has the perverse effect of inducing manufacturers of defective products to leave these products on the market, rather than withdraw them.
A Government Of Limited Powers, Carl E. Schneider
A Government Of Limited Powers, Carl E. Schneider
Articles
Roscoe C. Filburn owned a small farm in Ohio where he raised poultry, dairy cows, and a modest acreage of winter wheat. Some wheat he fed his animals, some he sold, and some he kept for his family's daily bread. The Agricultural Adjustment Act of 1938 limited the wheat Mr. Filburn could grow without incurring penalties, but his 1941 crop exceeded those limits. Mr. Filburn sued. He said Claude Wickard, the Secretary of Agriculture, could not enforce the AAI's limits because Congress lacked authority to regulate wheat grown for one's own use. He reasoned: In our federal system, the states …
Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg
Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg
Articles
Controversy over recent revelations concerning the adverse cardiovascular effects of selective cyclooxygenase- 2 (COX-2) inhibitors has generally been framed as a story of regulatory failure, in which the Food and Drug Administration (FDA) has failed in its mission to protect the public from unsafe products. But this simplistic understanding of the mission of the FDA seems to make failure all but inevitable, if the reliable observation of the risks and benefits of a drug requires rigorous long-term studies. Perhaps in an earlier era the goal of drug regulation was simply to protect the public from poisons. Today, drug regulation guides …
The Problem Of New Uses, Rebecca S. Eisenberg
The Problem Of New Uses, Rebecca S. Eisenberg
Articles
Discovering new uses for drugs that are already on the market seems like it ought to be the low-lying fruit of biopharmaceutical research and development (R&D). Firms have already made significant investments in developing these drugs and bringing them to market, including testing them in clinical trials, shepherding them through the FDA regulatory approval process, building production facilities, and training sales staff to market them to physicians. By this point, the drugs have begun to enjoy goodwill among patients and physicians and casual observations in the course of clinical experience may point to potential new uses. One might expect that …
Border Patrol, Carl E. Schneider
Border Patrol, Carl E. Schneider
Articles
Recently, the Supreme Court has encountered cases that concern perhaps our weightiest bioethical issue-how medical care is to be rationed. But this does not mean that the Court must therefore assess the justice of rationing, as many people incited by many journalists now fondly and firmly believe. In explaining why, we begin with a story about how Learned Hand remembered saying one day to Justice Holmes, "Well, sir, goodbye. Do justice!" Holmes turned quite sharply and said: "That is not my job. My job is to play the game according to the rules." If the Court doesn't do justice, what …
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Other Publications
It's a great honor for me to be invited to deliver the Levine Distinguished Lecture at Fordham, and a great opportunity to try out some new ideas before this audience. As some of you know, I've been studying the role of patents in biomedical research and product development ("R&D") for close to twenty years now, with a particular focus on how patents work in "upstream" research in universities and biotechnology companies that are working on research problems that arise prior to "downstream" product development. But, of course, the patent strategies of these institutions are designed around the profits that everyone …
Going To Pot, Carl E. Schneider
Going To Pot, Carl E. Schneider
Articles
In several earlier columns, I suggested that judges are usually poorly placed to make good biomedical policy, not least because the law so rarely offers them direct and cogent guidance. Recently, the U.S. Court of Appeals for the Ninth Circuit proffered a new example of this old problem. In 1996, California's voters approved Proposition 215. Its "Compassionate Use Act of 1996" provided -that a patient "who possesses or cultivates marijuana for the personal medical purposes of the patient upon the written or oral recommendation or approval of a physician" committed no crime.
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Articles
Advances in fundamental biomedical research play an important and growing role in the development of new therapeutic and diagnostic products. Although the development of pharmaceutical end products has long been a proprietary enterprise, biomedical research comes from a very different tradition of open science. Within this tradition, long-standing norms call for relatively unfettered access to fundamental knowledge developed by prior researchers. The tradition of open science has eroded considerably over the past quarter century as proprietary claims have reached farther upstream from end products to cover fundamental discoveries that provide the knowledge base for future product development.
Road Work: Racial Profiling And Drug Interdiction On The Highway, Samuel R. Gross, Katherine Y. Bames
Road Work: Racial Profiling And Drug Interdiction On The Highway, Samuel R. Gross, Katherine Y. Bames
Articles
Hypocrisy about race is hardly new in America, but the content changes. Recently the spotlight has been on racial profiling. The story of Colonel Carl Williams of the New Jersey State Police is a wellknown example. On Sunday, February 28, 1999, the Newark Star Ledger published a lengthy interview with Williams in which he talked about race and drugs: "Today... the drug problem is cocaine or marijuana. It is most likely a minority group that's involved with that."4 Williams condemned racial profiling - "As far as racial profiling is concerned, that is absolutely not right. It never has been con-doned …