Law Commons^™

Equitable Prescription Drug Coverage: Preventing Sex Discrimination In Employer-Provided Health Plans, Stephen F. Befort, Elizabeth C. Borer

Louisiana Law Review

No abstract provided.

Punishing Pharmaceutical Companies For Unlawful Promotion Of Approved Drugs: Why The False Claims Act Is The Wrong Rx, Vicki W. Girard

Georgetown Law Faculty Publications and Other Works

This article criticizes the shift in focus from correction and compliance to punishment of pharmaceutical companies allegedly violating the Food, Drug, & Cosmetic Act (FD&C Act) prohibitions on unlawful drug promotion. Traditionally, the Food and Drug Administration (FDA) has addressed unlawful promotional activities under the misbranding and new drug provisions of the FD&C Act. Recently though, the Justice Department (DOJ) has expanded the purview of the False Claims Act to include the same allegedly unlawful behavior on the theory that unlawful promotion “induces” physicians to prescribe drugs that result in the filing of false claims for reimbursement. Unchecked and unchallenged, …

Fixing A Hole: Will Generic Biologics Find A Niche Within The Hatch-Waxman Act?, Elysa B. Goldberg

Fordham Intellectual Property, Media and Entertainment Law Journal

No abstract provided.

Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Michael A. Carrier

Michigan Law Review

A tidal wave of high drug prices has recently crashed across the U.S. economy. One of the primary culprits has been the increase in agreements by which brand-name drug manufacturers and generic firms have settled patent litigation. The framework for such agreements has been the Hatch-Waxman Act, which Congress enacted in 1984. One of the Act's goals was to provide incentives for generics to challenge brand-name patents. But brand firms have recently paid generics millions of dollars to drop their lawsuits and refrain from entering the market. These reverse-payment settlements threaten significant harm. Courts nonetheless have recently blessed them, explaining …

Pushing Drugs Or Pushing The Envelope: The Prosecution Of Doctors In Connection With Over-Prescribing Of Opium-Based Drugs, Deborah Hellman

Deborah Hellman

No abstract provided.

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 …

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 …

The Physician Payments Sunshine Act And The Problem Of Pharmaceutical Companies' Influence Over Prescribing Physicians, Andrew L. Younkins

Andrew L Younkins

Recently, concerns over physicians' conflict of interest have increased as the details of some doctors' consulting relationships with pharmaceutical companies surface. In an effort to cleanse medicine of egregiously conflicted doctors, Senator Grassley proposed of the Physician Payments Sunshine Act ("PPSA") in the Senate last year. The Act mandates reporting of uncommonly large payments by drug companies to doctors, but does not confront the panoply of more subtle yet more powerful methods the drug industry uses to influence prescriber behavior. This paper argues that industry-sponsored CME, small gifts, drug samples and drug detailers unconsciously influence physician prescribing behavior, and that …

Race In The War On Drugs: The Social Consequences Of Presidential Rhetoric, Jeff L. Yates, Andrew Whitford

Jeff L Yates

One of the president’s main leadership tools for influencing the direction of American legal policy is public rhetoric. Numerous studies have examined the president’s use of the “bully pulpit” to lead policy by influencing Congress or public opinion, or by changing the behavior of public agencies. We argue that the president can use rhetoric to change the behavior of public agencies and that this can have important social consequences. We focus on the disproportionate impact of presidential rhetoric on different “target populations” in the context of the War on Drugs. Specifically, we observe that presidential rhetoric had a greater impact …

Does Misery Love Company - Evidence From Pharmaceutical Markets Before And After The Orphan Drug Act, Frank R. Lichtenberg, Joel Waldfogel

Michigan Telecommunications & Technology Law Review

The possibility that small populations would see few medications developed for their conditions has [...] led the U.S. Congress to pass the 1983 Orphan Drug Act ("ODA"), giving firms special incentives to develop drugs for diseases afflicting fewer than 200,000 persons per year.[...][U]under the Act, drug makers receive seven years of exclusive marketing upon FDA approval of newly-developed drugs qualifying as "orphan drugs"--i.e., drugs for disorders affecting fewer than 200,000 persons.[...]Together, [the] provisions (a) increase the effective market size; and (b) reduce fixed (sunk) costs. In doing so, the Act provides a natural experiment for measuring the impact of increased …

Pdufa And Initial U.S. Drug Launches, Mary K. Olson

Michigan Telecommunications & Technology Law Review

In the 1970s and 1980s, many pharmaceutical firms launched new drugs abroad prior to gaining U.S. approval. Consequently, U.S. patients often faced delays in accessing important new medicines. High regulatory barriers to entry, such as a stringent regulation and a lengthy drug review process, contributed to this problem. This Article examines the impact of the Prescription Drug User Fee Act (PDUFA), and subsequent increases in the speed of FDA review, on the likelihood of initial U.S. drug launches. These factors are hypothesized to lower regulatory barriers to entry in the U.S. pharmaceutical market. The results show that increased drug review …

Why Fdca Section 505(U) Should Not Concern Us Greatly, Kyle Faget

Michigan Telecommunications & Technology Law Review

Among the many amendments found in the Food and Drug Administration Amendment Act of 2007 (FDAAA) is a provision at the end of the act, Section 505(u), which grants chiral switches five years of market exclusivity under certain circumstances. Prior to Congressional enactment of the FDAAA, the Food and Drug Administration (FDA) refused to award new chemical entity (NCE) status to enantiomers of previously approved racemic mixtures. The FDA defines a new chemical entity ("NCE") as a drug that contains no active moiety that has been approved by the FDA in any other application submitted under Section 505(b) of the …

Generic Preemption: Applying Conflict Preemption After Wyeth V. Levine, Hannah B. Murray

Michigan Telecommunications & Technology Law Review

If a generic manufacturer does not have control over its safety warnings, can it comply with the obligations posed by state tort liability? State failure-to-warn actions evaluate whether a product manufacturer has met its obligation to warn consumers about known dangers associated with its product. In essence, if a manufacturer knows about a potentially dangerous outcome, it has a duty to warn its consumers. If the generic manufacturer can comply with a state duty to warn only by changing a label that the FDA will not allow it to change, it becomes impossible for the corporation to meet both requirements. …

The Chinese Regulatory Licensing Regime For Pharmaceutical Products: A Law And Economics Analysis, Qing Zhang

Michigan Telecommunications & Technology Law Review

China's pharmaceutical market has expanded dramatically in the past twenty years and is expected to become the largest in the world by the year 2050. However, entry to the market remains difficult for many international pharmaceutical manufacturers due to the country's costly and complicated regulatory licensing requirements. This Article provides an overview of the regulatory licensing regime for pharmaceutical products in China. Then, the Article evaluates three key features of the regulatory licensing regime through a law and economics approach. These features include the use of licensing, as contrasted with alternative regulatory and non-regulatory mechanisms; the standards to be met …

Platitudes About Product Stewardship In Torts: Continuing Drug Research And Education, Lars Noah

Michigan Telecommunications & Technology Law Review

This Article focuses on one emerging aspect of tort litigation against pharmaceutical manufacturers that, if it gained traction, portends a dramatic (and potentially counterproductive) expansion in the prescription drug industry's exposure to liability. The traditional theories of products liability--mismanufacture, defective design, and inadequate warnings--no longer exhaust the potential obligations of sellers. In addition to increasingly popular claims of misrepresentation and negligent marketing, which seem more like extensions of the three defect categories than entirely novel theories, a growing chorus of commentators would impose on pharmaceutical manufacturers a broader duty to test and educate (aspects of what they call an obligation …

When And How To Defer To The Fda: Learning From Michigan's Regulatory Compliance Defense, Jason C. Miller

Michigan Telecommunications & Technology Law Review

Michigan's regulatory compliance defense properly recognizes that an FDA-approved drug carrying an FDA-approved label should not be considered defective. However, the statute's absolute immunity provides no compensation for injured parties in any circumstance, including situations where the FDA process has failed. Nevertheless, it is possible to treat the FDA's approval as significant without eliminating the possibility of all state actions against drug makers by providing a litigation back-up through state attorneys general ("AGs"). This Note examines the question of FDA approval in state tort actions in Part I, discusses Michigan's answer to that question in Part II, and offers a …

Vindicating The Matriarch: A Fair Housing Act Challenge To Federal No-Fault Evictions From Public Housing, Melissa A. Cohen

Michigan Journal of Gender & Law

Pearlie Rucker, sixty-three years old, had been living in public housing in Oakland, California for thirteen years. Ms. Rucker lived with her mentally disabled adult daughter, Gelinda, as well as two grandchildren and one great-grandchild. Ms. Rucker regularly searched Gelinda's room for signs of drugs, and had warned Gelinda that any drug activity on the premises could result in eviction. Nevertheless, Gelinda was caught with drugs three blocks from the apartment. Despite the fact that Ms. Rucker had no knowledge of Gelinda's drug activity, and in fact had been carefully monitoring what happened in her apartment, the Oakland Housing Authority …

Pursuing The Perfect Mother: Why America's Criminalization Of Maternal Substance Abuse Is Not The Answer- A Compartive Legal Analysis, Linda C. Fentiman

Michigan Journal of Gender & Law

In this Article the author will examine not only the substantive legal differences between the United States, Canada, and France, but will also explore how these legal rules fit within a broader social, political, and religious setting. This Article will pursue four lines of inquiry. First, it will briefly chronicle the history of criminal prosecution of pregnant women in America and show how these prosecutions have become markedly more aggressive over the last twenty years. Second, it will situate these prosecutions in the full context of American law and culture, demonstrating how the fetus has received increasing legal recognition in …

No Rational Basis: The Pragmatic Case For Marijuana Law Reform, Eric Blumenson

Eric Blumenson

This article presents a critique of marijuana prohibition and suggests some alternative regulatory approaches that would be more productive and consonant with justice. Part I relies on a forty-year empirical record to demonstrate that (1) reliance on a law enforcement approach has aggravated rather than mitigated the risks involved with marijuana use, and (2) criminalization, which results in the arrest of more than 700,000 Americans annually for possession of any amount of marijuana, is an inhumane and destructive response to an act that almost 100 million Americans have committed. Part II assesses the relative merits of several alternative reform policies, …

In The Name Of Fetal Protection: Why American Prosecutors Pursue Pregnant Drug Users (And Other Countries Don't), Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

For more than three decades, American prosecutors have been bringing criminal prosecutions against pregnant women based on their use of drugs while pregnant, with charges ranging from child abuse or neglect to murder. Almost all of these women are poor, and the vast majority are also women of color--many with histories of childhood sexual or physical abuse and mental disability. In all but three states-Alabama, Kentucky, and South Carolina--such prosecutions have been declared unconstitutional or the resulting convictions have been overturned. Nonetheless, prosecutions continue to be brought, in what can only be described as a crusade against pregnant women in …

Where Is The Privacy In Wada's "Whereabouts" Rule? , James Halt

Marquette Sports Law Review

No abstract provided.

The Implications Of Post-Phase 1 And "Off-Label" Treatment Use Of Experimental Drugs: How Expansive Should Expanded Access Be?, Patricia J. Zettler

Faculty Publications By Year

No abstract provided.