35,137 research outputs found
Wayne N. Curtis Oral History Interview, 2008
No full textThis interview of Wayne Curtis was conducted as part of the William and Mary GALA Stephens Oral History Project by Michael Rawlings. Wayne N. Curtis graduated from the College of William and Mary in 1982 with a AB in History. He joined William and Mary GALA in 1987, served as a board member in the 1990s, and has served as president from 2003 to the present (2008). This interview is part of the University Archives Oral History Collection (http://scrc.swem.wm.edu/index.php?p=collections/controlcard&id=6613) in the Special Collections Research Center, Swem Library, College of William and Mary.William and Mary Gay and Lesbian Alumni, Inc
Michael Rodriguez interviews fiction writer Michael Kimball
No full textAuthor Michael Kimball talks about moving away from Michigan to become a successful writer, his education, the fiction reading series he has started in Baltimore, the life-story-on-postcard project, and his book "Dear everybody." Kimball is interviewed by Michigan State University Librarian Michael Rodriguez for the Michigan State University Libraries' Michigan Writers Series
Michael Rodriguez interviews author Gary Gildner
No full textAuthor Gary Gildner explains why he left his tenured teaching position to move to Idaho to became a full-time writer of poetry. Gildner talks about donating his personal papers to Michigan State University Libraries' Special Collections, his writing style and how he approaches writing. Gildner is interviewed by MSU Librarian Michael Rodriguez for the MSU Libraries' Michigan Writer Series. Held at the MSU Main Library
Dr. Michael Janis, Morehouse College, August 2011, August 2011
No full textThis video is a conversation with Dr. Michael Janis. Dr. Janis talks about his book, "Africa After Modernism: Transitions in Literature, Media and Philosophy". Yolanda Gilmore-Bivins, AUC Woodruff Library, is the interviewer
Why A "Large and Unjustified" Payment Threshold is Not Consistent with Actavis
No full textFTC v. Actavis was a landmark antitrust decision. In rejecting the “scope of the patent” test that had immunized settlements by which brand-name drug firms pay generic companies to delay entering the market (“exclusion payment settlements”), the Supreme Court made clear that such agreements “tend to have significant adverse effects on competition” and could violate the antitrust laws.
Some lower courts and defendants have sought to sow ambiguity in the post-Actavis caselaw by creating new thresholds and frameworks not articulated or envisioned by the Court. In particular, they have latched onto the discussion in Actavis of a “large and unjustified” payment. The district court in In re Loestrin 24 FE Antitrust Litigation, for example, imposed a framework that required analysis of (1) whether “there [is] a reverse payment” and (2) whether “that reverse payment is large and unjustified” before addressing (3) the rule of reason. The Loestrin court borrowed this framework from the district court in In re Lamictal Direct Purchaser Antitrust Litigation. And defendants have contended, for example, that “Actavis requires a plaintiff challenging a reverse-payment settlement . . . to prove, as a threshold matter, that the . . . payment was both large and unjustified” and that “under Actavis, [plaintiffs] have to prove that [a] payment was ‘large’ (as well as unexplained).”
This article offers three reasons why a requirement that a plaintiff demonstrate a large and unjustified payment before reaching the Rule of Reason is not consistent with Actavis. First, nearly all of the Court’s discussion of large and unjustified payments occurred in contexts having little to do with the antitrust analysis that future courts were to apply. Second, the Court instructed lower courts to apply the Rule of Reason, not a new framework with a threshold it never mentioned. And third, such a threshold is inconsistent with the Court’s (1) allowance of shortcuts for plaintiffs to show anticompetitive effects and market power and (2) imposition of the burden on defendants to show justifications for a payment
Product Hopping: A New Framework
No full textOne of the most misunderstood and anticompetitive business behaviors in today’s economy is “product hopping,” which occurs when a brand-name pharmaceutical company switches from one version of a drug to another. These switches, benign in appearance but not necessarily in effect, can significantly decrease consumer welfare, impairing competition from generic drugs to an extent that greatly exceeds any gains from the “improved” branded product. The antitrust analysis of product hopping is nuanced. It implicates the intersection of antitrust law, patent law, the Hatch-Waxman Act, and state drug product selection laws. In fact, the behavior is even more complex because it occurs in uniquely complicated markets characterized by doctors who choose the product but don’t pay for it, and consumers who buy the product but don’t choose it. It is thus unsurprising that courts have offered inconsistent approaches to product hopping. They have paid varying levels of attention to the regulatory structure, offered a simplistic analysis of consumer choice, adopted an underinclusive antitrust standard based on coercion, and focused on whether the brand firm removed the original drug from the market. Entering this morass, we offer a new framework that courts, government enforcers, plaintiffs, and manufacturers can employ to analyze product hopping. This rigorous and balanced framework is the first to incorporate the economic characteristics of the pharmaceutical industry. For starters, it defines a “product hop” to include only those instances in which the brand manufacturer (1) reformulates the product in a way that makes the generic non-substitutable and (2) encourages doctors to write prescriptions for the reformulated product rather than the original. The test also offers two safe harbors, which are more deferential than current caselaw, to ensure that the vast majority of reformulations will not be subject to antitrust scrutiny. The analysis then examines whether a brand’s product hop passes the “no-economic-sense” test. In other words, would the reformulation make economic sense for the brand if it did not have the effect of impairing generic competition? Merely introducing new products would pass the test. Encouraging doctors to write prescriptions for the reformulated rather than the original product—“cannibalizing” the brand’s own sales—might not. Imposing antitrust liability on behavior that does not make business sense other than through its impairment of generic competition offers a conservative approach and minimizes “false positives” in which courts erroneously find liability. Showing just how far the courts have veered from justified economic analysis, the test would recommend a different analysis than that used in each of the five product-hopping cases that have been litigated to date, and a different outcome in two of them. By carefully considering the regulatory environment, practicalities of prescription drug markets, manufacturers’ desire for clear-cut rules, and consumers’ needs for a rule that promotes price competition without deterring valued innovations, the framework promises to improve and standardize the antitrust analysis of product hopping
Square Dancing with the Stars to Enhance Dynamic Hirschman Linkages?
No full textIn this Presidential Address, the author takes the reader on a reconnaissance of his life and time as a regional scientist. He points out scenery he found scintillating along the way, hoping that some may pick up the banner and chew on a few of the ideas for a while. He suggests a revisit to Albert O. Hirschman’s notion of key sectors and more empirical analysis related to Marcus Berliant’s and Masahisa Fujita’s notion of knowledge creation and transfer.Presidential Address, San Antonio, Texas, March 29, 2014 (53rd Meetings of the Southern Regional Science Association
Author Response to the Review of Earning a Life by Michael Bourdillon
No full textAuthor Response to the Review of Earning a Life by Michael Bourdillo
Citizen Petitions: Long, Late-Filed, and At-Last Denied
No full textThe pharmaceutical industry is ground zero for many of the most challenging issues at the intersection of antitrust and intellectual property law. It also presents a complex regulatory regime that is ripe for anticompetitive behavior. It thus should not be a surprise that the industry has been subject to rigorous antitrust scrutiny in recent years.
While settlements between brand and generic firms and “product hopping” from one version of a drug to another have received attention, one behavior has avoided serious scrutiny. Brand firms’ filing of citizen petitions with the U.S. Food and Drug Administration (FDA) has almost entirely slipped beneath the radar. While citizen petitions in theory could raise concerns that a drug is unsafe, in practice they bear a dangerous potential to extend brand monopolies by delaying approval of generics at a potential cost of millions of dollars per day.
This Article offers an empirical study of “505(q)” citizen petitions, which ask the FDA to take specific action against a pending generic application. It analyzes every 505(q) petition filed with the FDA between 2011 and 2015, documenting (1) the number of petitions each year, (2) who filed the petitions, (3) the success rate of the petitions, (4) the petitions’ length, (5) whether petitions were filed in close proximity to the expiration of a patent or data exclusivity, and (6) occasions in which the FDA approved generics on the same day it decided petitions.
The study finds that brand firms filed 92% of 505(q) petitions. And it concludes that the FDA granted an astonishingly low 8% of petitions, rejecting a full 92%. Why is the grant rate so low? We consider several reasons. First, in the past 5 years, the average length of petitions has more than doubled, and the FDA almost never grants petitions with a length above the mean. Second, 39% of petitions are filed within 6 months of the expiration of a patent or FDA exclusivity, with almost all of these petitions denied. Third, the FDA resolved a number of petitions on the same day it approved the generic, suggesting that the Agency delayed generic approval until it resolved the petition. These three settings resulted in grants of only 3%, 2%, and 0%, respectively.
The Article concludes by offering examples of serial petitions, late-filed petitions, and a combination of petitions with other behavior, such as product hopping and settlements. In short, citizen petitions represent a hidden tool in a brand firm’s toolkit of entry-delaying activity that can lead to consumers paying high drug prices while providing no offsetting safety benefit
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