Filed under: Compliance, Health Law, Seton Hall Law
At Seton Hall Law’s website, Victoria Dorum reports that Seton Hall Law students Lindsey Borgeson, Joyce Crawford, and Phillip DeFedele (pictured above, from left), along with alternate Cynthia Frumanek, recently came in first at the University of Maryland Francis King Carey School of Law’s Health Law Regulatory and Compliance Competition.
Not only did the team members distinguish themselves among other top schools, they also made a profound impression on the judges. Virginia Rowthorn, Managing Director of the Law & Health Care Program at the University of Maryland School of Law, wrote a note to [Seton Hall Law Professor Tara Adams Ragone] to commend the team and their teachers for the team’s excellent presentation. She wrote, “One of the judges who heard them told me they knocked it out of the ballpark with their knowledge, and also with the professional way they presented their ‘case’.”
This has been a great academic year for Seton Hall Law, which also won the National Health Law Moot Court Competition in November. Dorum covered that victory as well, here.
Seton Hall Law’s John Jacobi Named One of New Jersey’s Top 10 Healthcare Policy Analysts and Experts
NJ Spotlight has named Seton Hall Law Professor John Jacobi one of New Jersey’s top ten healthcare policy experts.
Reporter Andrew Kitchenman writes:
Jacobi is the state’s foremost expert on the intersection of health law and policy, and he knows state government from the inside and out, having served in Gov. Jon Corzine’s counsel’s office. Jacobi’s research outlined many of the challenges and opportunities of having a state-based health insurance exchange. While Gov. Chris Christie opted against it, Jacobi remains a top voice on health law and policy.
The complete list is here.
HEALTH LAW STUDENT SCHOLARSHIPS
This award recognizes promising health law students with an aptitude for and commitment to a career in health law with a focus on the legal and compliance issues facing bio/pharmaceutical and/or medical technology industries.
Each nominee must qualify under the following criteria:
- The nominee shall be a second or part-time third year law student currently enrolled in an accredited North American law school* on a full or part-time basis who through his/her law school academic and clinical work and other related activities demonstrates his/her aptitude for and commitment to a legal career in health care law within the bio/pharmaceutical and/or medical technology industries.
- The nominee must be available to attend the June Healthcare Compliance Certification Program.
- Multiple nominations per law school may be made.
- The following materials must be submitted by the nominee (the submission of additional material is discouraged):
- A signed letter from the Dean, clinical program director, or law school professor teaching in a related area nominating the candidate and setting forth the basis for the nomination, including a description of the purposes and content of the class or clinical program in which the student is enrolled (PDF copy acceptable).
- The nominee’s current resume including most recent GPA (electronic copy required).
- A brief personal statement (maximum two (2) typewritten pages) highlighting the nominee’s background, experience, and other relevant information that qualifies him/her for the scholarship (electronic copy required).
All applications will be judged by members of the Seton Hall Law School Faculty. All decisions are final. Applications will be judged on the strength of the eligibility criteria, letter of nomination and personal statement. No scholarship will be awarded if the faculty members determine that no application meets the scholarship standards.
A maximum of two full scholarships shall be awarded each year. Scholarship recipients will attend the June Healthcare Compliance Certification Program. The scholarship covers program tuition, educational materials, meals during the program, and parking. Please note that transportation and hotel costs are not included.
SUBMISSION DEADLINE: February 7, 2014.
Entries must be submitted:
- Via email to HealthLaw@shu.edu; or
- Mailed to:
Center for Health & Pharmaceutical Law
Attn: Catherine Finizio
Seton Hall Law School
One Newark Center
Newark, NJ 07102
Please contact Catherine Finizio at firstname.lastname@example.org or 973-642-8871.
Filed under: Drug Pricing, Drugs & Devices, Health Law, Seton Hall Law
Here at Seton Hall Law, the halls are filled with the sounds of students again, which means our summer-long blog hiatus has come to an end. We’re excited to get back to blogging at Health Reform Watch!
As always, the blog will feature analysis and commentary from Seton Hall’s health law faculty and Recommended Reading posts highlighting the health law scholarship we’ve been reading and enjoying. It will also include contributions from the students in our health law program as well as announcements of program activities.
Guest posts on health and pharmaceutical law and policy topics are welcome, so please contact me, Kate Greenwood, at email@example.com if there’s something you’d like to share.
. . .
From the beginning, the content of Health Reform Watch has been driven by the diverse interests and expertise of Seton Hall’s health law faculty. In my case, that’s maternal and child health, drug and device law and policy, and, most especially, the intersection of the two. In recent months, I have focused on the regulation of orphan drugs (a video of me opining about the same can be found here), and so yesterday’s news that the Australian government has decided to pay the $110,000 per-course-of-treatment price for Bristol-Myers Squibb’s melanoma drug Yervoy caught my attention. What’s newsworthy is not Australia’s decision to pay – other countries are, too – but rather its plan for making sure it is getting its money’s worth. As reporter Wendy Carlisle explains, Australia’s Pharmaceutical Benefits Advisory Committee will for the first time be conducting its own epidemiological study.
As is the case with many orphan drugs, Yervoy was approved on the basis of clinical trials that were relatively small. A 2011 review conducted by Aaron Kesselheim, Jessica Meyers, and Jerry Avorn of all new oncology drug approvals from 2004 through 2010 in oncology revealed that “the FDA ha[d] approved alternative trial designs that allowed most orphan cancer drugs to be approved on the basis of single-group, nonrandomized trials that enrolled comparatively small numbers of patients.” EvaluatePharma recently estimated that regulators require a median phase III trial size of 528 patients, at an estimated average cost of $85 million, for orphan drugs, as compared to 2,234 patients, at an estimated average cost of $186 million, for non-orphan drugs.
When it comes to clinical trials, smaller is not better. As the chair of Australia’s Pharmaceutical Benefits Advisory Committee, Dr. Suzanne Hill, explains, “[i]f we are going to look at new products and try to judge them on the basis of smaller clinical trials – which is what is happening – then we are going to be less confident about the clinical trial data when we see them for making recommendations[.]“ To shore up the Committee’s confidence in Yervoy, it will be tracking “who gets prescribed it, what happens to them, how long do they get treatment for, how is the treatment … put in the context of other treatments that they have and what happens to the outcome?” The Committee’s ultimate goal is to determine whether “we get the survival benefit in the community that we saw in the trials[.]”
The number of orphan drugs, many of which cost in excess of $100,000, is climbing and is expected to continue to do so. EvaluatePharma estimates that “the worldwide orphan drug market is set to grow to $127 [billion], a compound annual growth rate of +7.4% per year between 2012 and 2018[,]” which “is double that of the overall prescription drug market, excluding generics, which is set to grow at +3.7% per year.” Given these expected trends, there is no doubt that regulators and payers will increasingly look to post-marketing studies to supplement the available clinical trial data about orphan drugs, whether they conduct the studies themselves, as Australia is doing, or require manufacturers to shoulder the burden. Care must be taken to ensure that manufacturers remain incentivized to develop treatments for rare diseases, but there is evidence to suggest that regulators have room to maneuver. EvaluatePharma reports that “[t]he current stock of Phase III/Filed orphan products is expected to yield a return on investment of x10.3,” while the current stock of non-orphan products is only expected to yield a return on investment of x6.0.
Filed under: Accountable Care Organizations, Health Law, Seton Hall Law
Just a quick note to commend this issue to readers of HRW. As I note in an introduction to the volume, the articles are uniformly insightful contributions to very topical issues in health law and policy.
Volume 42, Issue 4 (2012) Symposium
Implementing the Affordable Care Act: What Role for Accountable Care Organizations?
Accountable Care Organizations in the Affordable Care Act
Accountable Care Organizations: Can We Have Our Cake and Eat It Too?
Jessica L. Mantel
Adopting Accountable Care Through the Medicare Framework
Baraba J. Zabawa, Louise G. Trubek, and Felice F. Borisy-Rudin
Reopening the Loophole: Avoiding Securities Fraud Debt Through Bankruptcy
Andrew L. Van Houter
Volume Forty-Two E-Board
- Temi Kolarova
- Executive Editor
- Daniel E. Bonilla
- Managing Editor
- Desiree L. Grace
- Symposium Editor
- Gianna Cricco-Lizza
- Business Editor
- Michael C. Smith
- Senior Articles Editor
- Jason S. Cetel
- Articles Editors
- Christopher Fox
- Meghan McSkimming
- Elizabeth C. Ralston
- Lauren Winchester
- Comments Editors
- Eric M. Dante
- Melissa M. Ferrara
- Brandon M. Fierro
- Rebecca Garibotto
- Terrance Romasco Gallogly
- Joseph K. Jakas
- Submissions Editors
- Robert S. Garrison Jr.
- Ryan P. Montefusco
- Andrew L. Van Houter