The Federalist Society - Southwestern Law School

This is an EXCELLENT discussion of Magna Carta and its relationship to the U.S. Constitution

Justice Scalia's Opening Remarks at 2014 National Lawyers Convention United States Supreme Court Justice Antonin Scalia opened the 2014 National Lawyers Convention on November 13 at the Mayflower Hotel in Washington, DC. Justi...

The true meaning of Justice Scalia By Lee Liberman Otis // When Justice Antonin Scalia joined the Supreme Court in 1986, I was in his first group of law clerks...

Nino - Ricochet It’s rare for the discussion in the faculty lounge to stay on one topic for an entire hour, but how could it not when the subject is the late, great Antonin Scalia? In this episode, Professors Epstein and Yoo recall their personal memories of the departed Supreme Court justice, explain his place in…

In preparation for next weeks discussion panel. . .

Religious Liberty after Hobby Lobby - Event Video The Federalist Society's Religious Liberties Practice Groups presented this panel on "Religious Liberty after Hobby Lobby" on Thursday, November 13, during the 2014 National Lawyers Convention.

Today Judge Sandra Ikuta, Ninth Circuit Court of Appeals spoke to students about what its like to be a federal appellate judge, her most memorable case, and the reputation of the Ninth Circuit!! Thanks to everyone who attended!

The Federalist Society invited U.S. Court of Appeals Judge Sandra S. Ikuta to campus today to share what it's like to be a Ninth Circuit Judge.

The Federalist Society hosted an evening with Hon. Alex Kozinski, Chief Judge of the 9th Circuit Court of Appeals, yesterday evening. Professor Joerg Knipprath gave an introduction and Federalist Society President Alexis Fragosa moderated the discussion with the Chief Judge, where they talked about some of his most noteworthy cases, his controversial opinions, and what you'll find when you Google him. Judge Kozinski also gave advice on when to stay silent in the courtroom and how to become a judge by age 35.

Hey Southwestern Law School friends! Today Professor Ramachandran will be debating with Yaron Brook from the The Ayn Rand Institute!

Come to the Louis Room on the second floor of the Bullocks Wilshire building to catch the action!

Missed our panel discussion?

Find the link below!

http://videolibrary.swlaw.edu/federalist/federalist_03-19-14.mp4

This afternoon, the Federalist Society hosted a public interest panel discussion featuring John Eastman, Founding Director, Center for Constitutional Jurisprudence, Claremont Institute; Jeanne Hoffman, Director of Talent Research, Institute for Humane Studies, George Mason University; Elan Journo, Fellow and Director of Policy Research, Ayn Rand Institute; and Melissa Palmer, Director of Development, Reason Magazine. Moderated by Professor Byron Stier, the panelists discussed working in the public interest realm and the importance of networking, among other topics.

MISSED ONE OF OUR EVENTS??

Find links to recordings of our events at FED-SOC.ORG!

FDA Involvement in Off-Label Drug Use - Event Video » Publications » The Federalist Society On January 13, 2014 the Southwestern Law School Federalist Society student chapter hosted a debate about the FDA's role in regulating off-label drug use featuring Professor Richard Epstein, the Laurence A. Tisch Professor of Law at NYU and the Kirsten Bedford Senior Fellow at the Hoover Institution,...

On January 13, 2014 the Southwestern Law School Federalist Society student chapter hosted a debate about the FDA's role in regulating off-label drug use featuring Professor Richard Epstein, the Laurence A. Tisch Professor of Law at NYU and the Kirsten Bedford Senior Fellow at the Hoover Institution, and Ryan Abbott, Associate Professor of Law at Southwestern Law School and Visiting Assistant Professor of Medicine at the David Geffen School of Medicine at UCLA.

Before a drug can be sold legally in the United States, the Food and Drug Administration (FDA) must approve it as safe and effective for a particular indication or use — the use then appears on the drug's label. Federal law, however, allows doctors to prescribe drugs that the FDA has approved for one indication for any other indication, even though the FDA never evaluated the safety or efficacy of the drug for that use.

Off-label prescribing is an integral part of modern-day medicine. Patients may benefit when they receive drugs or devices in contexts not approved by the FDA. In fact, in some instances an off-label use may be the standard of care for a particular health problem. However, off-label prescribing can also harm patients, especially when an off-label use lacks a solid evidentiary basis.

For this reason, the FDA forbids drug companies from promoting their own products for off-label use, except for certain activities such as disseminating research literature and sponsoring educational programs. In recent years, civil and criminal actions against drug companies for illegal promotion for off-label use have proliferated, leading to many large settlements. For example, in July 2012, GlaxoSmithKline pled guilty and paid $3 billion to resolve criminal and civil liability arising from the company's unlawful prescription drug promotion, failure to report safety data, and false price reporting practices.

As a result of this recent litigation, many have questioned the FDA's current role in regulation of off-label use and whether more or less intervention is needed. This debate sought to address these very issues.


Both Professors have written about FDA regulations. For example, Professor Epstein in his book, Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation, and in an article in the Minnesota Law Review, "Against Permititis: Why Voluntary Organizations Should Regulate the Use of Cancer Drugs." Professor Abbott has written about FDA regulations in the Iowa Law Review, Big Data and Pharmacovigilance: Using Health Information Exchanges to Revolutionize Drug Safety, and he has an article forthcoming with Ian Ayres at Yale Law School on Mechanisms for Regulating Off-Label Drug Use.

FDA Involvement in Off-Label Drug Use: Debate between Richard Epstein and Ryan Abbott On January 13, 2014 the Southwestern Law School Federalist Society student chapter hosted a debate about the FDA's role in regulating off-label drug use feat...