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Volume 66, Issue 2
Citizen Petitions: Long, Late-Filed, and At-Last Denied

By Michael A. Carrier and Carl Minniti 66 Am. U. L. Rev. 305 (2016)

The 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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The Perils and Possibilities of Refugee Federalism

By Stella Burch Elias 66 Am. U. L. Rev. 353 (2016)

The international community is experiencing a refugee crisis.  The worldwide number of displaced persons has reached an all-time high.  Refugees and asylum seekers, however, now face unprecedented levels of hostility and opposition to their resettlement in the United States.  During the last three years, some states have been at the forefront of a movement to block the resettlement of refugees from the Middle East and asylum seekers from Central America in their jurisdictions.  Other states have been in the vanguard of an initiative to welcome those fleeing persecution on humanitarian grounds.  This Article explores this new phenomenon of “Refugee Federalism.”  The Article examines recent state responses to the resettlement of certain groups of refugees and asylees, in particular Middle Eastern refugees and Central American asylees.  The piece discusses some states’ attempts, through gubernatorial decrees, legislation, and litigation, to curtail the settlement of such refugees and asylees, as well as the countervailing movement by other states to support them.  The Article analyzes the perils and possibilities of state engagement with refugee and asylee resettlement.  It argues that, in accordance with the Supreme Court’s longstanding immigration federalism doctrine, states may not exclude refugees from their territories.  But, it also proposes that states may nonetheless benefit from playing a more active role in refugee selection, admission, and integration.

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Patents v. Antitrust: Preempting Conflict

By Matthew G. Sipe66 Am. U. L. Rev. 415 (2016)

The dissonance between patent law and antitrust law has persisted despite a century of attempts at harmonization.  This Article suggests an elegant, novel solution:  preemption doctrine.  Recognizing the limits of and costs associated with antitrust law, the U.S. Supreme Court has already held that where an alternative regulatory authority exists—and overlapping application of antitrust regulation would lead to conflict—antitrust law may be implicitly preempted.  But this doctrine remains almost entirely unexplored.  This Article applies preemption doctrine precedent to the patent-antitrust context, analyzing where patent regulatory authority exists and where simultaneous antitrust regulation is likely to generate conflicting guidance and requirements.  Under the Court’s precedent, this combination of overlap and conflict should be enough to support preemption, at least within certain categories of patent cases.  Moreover, this Article explores how the unique nature of patents and the interplay—and tension—that patent law alone has with antitrust law supports an even broader interpretation of existing preemption doctrine in this context.

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COMMENT: Fair for Whom? Why Debt-Collection Lawsuits in St. Louis Violate the Procedural Due Process Rights of Low-Income Communities

By Aimee Constantineau66 Am. U. L. Rev. 479 (2016)

Debt collection has burgeoned into a thriving industry over the past decade, and it is estimated to be a $13 billion dollar business today.  Yet, most of the 35% of American adults who owe an average debt of $5000 do not even know that a creditor is trying to collect the debt.  In St. Louis, Missouri, over 100,000 judgments were handed down in debt collection lawsuits from 2008 to 2012, and the overwhelming majority of those lawsuits were against low-income debtors.  Collectively, these debtors lost over $50 million in wages through garnishments, which often forced households into the unthinkable position of allocating what few resources remained.  And, more often than not, such financial strain drives families even further into debt because they seek out new loans to repay those debts.

The debt-collection process in Missouri, from the initial complaint to the garnishment of wages, is governed by a blend of federal and state law, both of which are antiquated and non-comprehensive.  This combination of laws fails to provide low-income residents of St. Louis with constitutionally adequate notice or an opportunity to be heard, thereby violating debtors’ procedural due process rights.  These violations lead to serious social and economic ramifications for the low-income residents of St. Louis. To remedy these constitutional shortcomings, lawmakers should provide for specially tailored notice requirements, access to legal counsel or advice, and additional financial protections to safeguard communities from the overly harsh practices of debt collectors.

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COMMENT: The New FISA Court Amicus Should Be Able to Ignore Its Congressionally Imposed Duty

By Ben Cook66 Am. U. L. Rev. 539 (2016)

After the Edward Snowden disclosures regarding the National Security Agency’s surveillance activities under the Foreign Intelligence Surveillance Act (FISA), Congress reformed both the substantive FISA surveillance laws and the procedural rules of the FISA Court (FISC)—the court Congress established in FISA to adjudicate government surveillance requests—to better protect privacy interests and increase the representation of privacy interests before the court.  Previously, the court very rarely heard opposition to the government’s arguments supporting surveillance requests.  The reform legislation—the USA FREEDOM Act—requires the court to hear from one of five pooled amici when it is presented with novel or significant interpretations of law.  The statute also requires those pooled amici to support arguments that advance individual privacy and civil liberties.

The statute, however, risks violating separation of powers principles if the amicus and FISC interpret the statute narrowly as preventing an amicus from advancing arguments that support intelligence collection or conflict with individual privacy interests.  While Congress retains total authority to control the jurisdiction and procedures of the FISC, the judicial power inherent in any court includes the authority to decide the law, administer justice, and control the amicus process.  By interfering with the court’s ability to consider which arguments it hears from an amicus that the court has appointed to materially assist in deciding the law, the statute would violate the separation of powers doctrine.  So, even if such a broad reading would render the amicus duty superfluous and insignificant, the court should interpret the amicus duty broadly to allow virtually any legal argument that the court deems helpful and appropriate.  A broad interpretation would allow the court to fulfill its constitutional obligations while avoiding the need to declare the statute in violation of the separation of powers. 

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COMMENT: Building Bridges: Why Expanding Optional Practical Training Is a Valid Exercise of Agency Authority and How It Helps F-1 Students Transition to H-1B Worker Status

By Pia Nitzschke66 Am. U. L. Rev. 593 (2016)

Should foreign students educated in the United States be encouraged to stay and join the workforce, thereby further driving the country’s economy?  It is this question that prompted this Comment.  Over centuries, there has been an ongoing debate over whether migrants take natives’ jobs and depreciate wages or whether they boost the economy.  This debate shaped the issue in Washington Alliance of Technology Workers v. United States Department of Homeland Security before the D.C. Circuit in 2016.  A technology worker’s union challenged a Department of Homeland Security (DHS) regulation allowing certain foreign students educated in the United States to remain in nonimmigrant student status for twenty-four months after completing their studies and to gain practical experience in the workplace.  The union argued that enacting the regulation was outside the agency’s powers and expressed the desire to remove the program established under this regulation.  The court ultimately ruled the case moot when DHS proposed—and, in March 2016, finalized—a new regulation allowing new graduates to remain for Optional Practical Training (OPT) for an even longer time.  Considering Chevron and analyzing the validity of and authority with which DHS enacted the 2016 regulation, this Comment finds that the regulation is a valid exercise of agency authority and a necessary bridge to incorporate foreign students into the U.S. workforce.  The U.S. immigration system leaves a gap where laws and regulations should assist U.S.-educated and highly trained migrants to establish a life in the United States.  This Comment argues, inter alia, that DHS’s regulation, discussed above, is a legally valid gap-filling measure and is crucial to continued American success and growth.

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