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Articles 1 - 10 of 10
Full-Text Articles in Law
Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Michael A. Carrier
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 …
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 …
Does Misery Love Company - Evidence From Pharmaceutical Markets Before And After The Orphan Drug Act, Frank R. Lichtenberg, Joel Waldfogel
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
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
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
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
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
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
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 …
Eatin' Good? Not In This Neighborhood: A Legal Analysis Of Disparities In Food Availability And Quality At Chain Supermarkets In Poverty-Stricken Areas, Nareissa Smith
Michigan Journal of Race and Law
Many Americans-especially the poor-face severe hurdles in their attempts to secure the most basic of human needs-food. One reason for this struggle is the tendency of chain supermarkets to provide a limited selection of goods and a lower quality of goods to patrons in less affluent neighborhoods. Healthier items such as soy milks, fresh fish, and lean meats are not present in these stores, and the produce that is present is typically well past the peak of freshness. Yet, if the same patron were to go to another supermarket owned by the same chain--but located in a wealthier neighborhood-she would …