1/20/16: Register Now! A Conversation with Margaret Hamburg, FDA Commissioner 2009-2015

A Conversation with Margaret A. Hamburg, FDA Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), speaks during an interview in Washington, D.C., U.S., on Wednesday, May 28, 2014. A new program that lets drugmakers move more quickly through the approval process for breakthrough products may help lower the cost of life-saving treatments, Hamburg, the nation's chief drug regulator, said today. Photographer: Andrew Harrer/Bloomberg via Getty ImagesCommissioner 2009-2015
January 20, 2016 12:30 PM
Wasserstein Hall, Milstein East ABC (2nd floor)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the Petrie-Flom Center for a conversation with former FDA Commissioner (and former New York City Health Commissioner), Dr. Margaret A. Hamburg, led by Peter Barton Hutt, former Chief Counsel to FDA and current Senior Counsel at Covington & Burling LLP and Lecturer on Law at HLS. Topics discussed will include FDA’s role and the changing scientific, legal, political, and economic landscape; the overlap of science, innovation, and cost regarding biomedical products; food safety and nutrition; challenges of globalization, and more.

Speakers:

  • Margaret A. Hamburg, Commissioner of the U. S. Food and Drug Administration, 2009-2015
  • Peter Barton Hutt, Covington & Burling and Harvard Law School

This event is free and open to the public, but seating is limited and registration is required. Register now!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.

‘The Week in Health Law’ Podcast

By Nicolas Terry

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This week we talked to Professor Mary Crossley of the University of Pittsburgh School of Law. Professor Crossley’s research has focused on issues of inequality in the financing and delivery of health care, encompassing topics ranging from an exploration of potential legal remedies for physician bias in medical treatment, to an examination of how recent trends in health insurance coverage function to discriminate against unhealthy people.

We focused on the “community benefit standard” for federal nonprofit status for hospitals. The ACA has imposed new requirements in this domain, including a Community Health Needs Assessment (CHNA). CHNA’s might spur hospitals to do more to address health disparities and improve quality. But what? And how?

In our lightning round, we discussed four recent developments in health law, including a  final rule issued by HHS with respect to HIPAA law enforcement exceptions related to reporting of “mental health prohibitors” for gun ownership to background check database; Changes to meaningful use in legislation introduced by Rob Portman; Charles Ornstein’s great work at ProPublica on HIPAA violations, and how massive health care bills still dog even insured patients;

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Juvenile crime is down and high school graduation is up: Good news or distraction?

By Robert Kinscherff

At first glance it seems like unequivocal good news: Juvenile crime rates are at approximately the same levels as the early 1970’s and high school graduation rates have risen from 65 percent four years ago to 82 percent in 2013-2014.  But, a closer look suggests a different picture under the surface of this aggregate national data.

Overall rates of juvenile crime have diminished considerably since the high-water mark in the late 1980’s and early 1990’s but “hot spots” of violent crime by juveniles and young adults—especially gun violence—persistently burn in neighborhoods of large cities like Detroit, Chicago, Oakland, Cleveland, and Baltimore as well as in smaller cities like Flint (MI), New Haven (CT), Rockford (IL), Odessa (TX), and Springfield (MA), and in many rural areas with intractable high poverty rates and which have seen gang infiltration in recent years. Read More

Products Liability or Medical Malpractice? The Definition of a “Healthcare Provider”

By Alex Stein

Every defendant in a suit for medically inflicted injuries wants to be a “healthcare provider.” This status entitles the defendant to categorize the suit as “medical malpractice” and become eligible to special litigation advantages, which include shortened limitations and repose periods, dismissal of suits not verified by experts, and statutory caps on damages.

In Verticor, Ltd. v. Wood, — S.W.3d —- 2015 WL 7166024 (Tex.App.–Austin 2015), the manufacturer of Eclipse Shield – a spinal implant for fusion – claimed to be a “healthcare provider” for purposes of the Texas Medical Liability Act (TMLA). The purpose of this claim was to recharacterize the products liability action filed against Verticor into a “healthcare liability claim” that can proceed to court only upon showing of medical malpractice verified by an expert. To establish this claim, Verticor argued that it provides the Eclipse Shield “for, to, or on behalf of a patient during the patient’s medical care, treatment, or confinement” under its “device manufacturer” license. This service, explained Verticor, makes it a “healthcare provider.” Read More