Monday, 4/11, HLS Health Law Workshop with Nathan Cortez

HLS Health Law Workshop: Nathan Cortez

April 11, 2016, 5-7 PM
Hauser Hall 105
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA 02138

Download the Presentation: “Regulation by Database”

Nathan Cortez is Associate Dean for Research and Associate Professor in Dedman School of Law at Southern Methodist University. He teaches and writes in the areas of health law, administrative law, and FDA law.  His research focuses on emerging markets in health care and biotechnology. He has become one of the world’s leading legal scholars on medical tourism, patient mobility, and cross-border health insurance.

His research also addresses mobile health technologies, how to regulate innovations that disrupt static regulatory regimes, the First Amendment restraints on FDA regulation (including FDA’s graphic tobacco warnings), immigration federalism, and alternative modes of regulation.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of March. The selections feature topics ranging from the characteristics and follow-up of post-marketing studies or conditionally authorized medicines in the European Union; to changes in prescription drug, over the counter drug, and dietary supplement use among older adults in the United States; to an assessment of the logic of Amarin’s off-label promotion of Vascepa. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Hey SP, Kesselheim AS. An Uninformative Truth: The Logic of Amarin’s Off-Label Promotion. PLoS Med. 2016 Mar 15;13(3):e1001978.
  2. Hoekman J, Klamer TT, Mantel-Teeuwisse AK, Leufkens HG, De Bruin ML. Characteristics and follow-up of post-marketing studies of conditionally authorised medicines in the EU. Br J Clin Pharmacol. 2016 Mar 18. [Epub ahead of print].
  3. Kapczynski A. Free Speech and Pharmaceutical Regulation-Fishy Business. JAMA Intern Med. 2016 Mar 1;176(3):295-6.
  4. Massey PR, Wang R, Prasad V, Bates SE, Fojo T. Assessing the Eventual Publication of Clinical Trial Abstracts Submitted to a Large Annual Oncology Meeting. 2016 Mar;21(3):261-8.
  5. Qato DM, Wilder J, Schumm LP, Gillet V, Alexander GC. Changes in Prescription and Over-the-Counter Medication and Dietary Supplement Use Among Older Adults in the United States, 2005 vs 2011. JAMA Intern Med. 2016 Mar 21. [Epub ahead of print]
  6. Yeh JS, Sarpatwari A, Kesselheim AS. Ethical and Practical Considerations in Removing Black Box Warnings from Drug Labels. Drug Saf. 2016 Mar 21. [Epub ahead of print]

Treasury Targets Corporate Inversion, Pfizer-Allergan Deal Falls Through

By Dalia Deak

The Treasury Department published regulations on Monday that took aim at corporate inversions – and, they hit their mark. Two days later, the merger of pharmaceutical giants Pfizer and Allergan, the largest planned inversion in history of the pharmaceutical industry, fell through.

The temporary and proposed regulations put forth on Monday make it more difficult for U.S.-parented multinational groups to change their tax residence to a low-tax country. This practice, the Treasury noted, is typically not to grow the underlying business or pursue other commercial benefits that may arise, but primarily to reduce their taxes. Companies will often follow up corporate inversions with another tactic—earnings stripping. This is where the company will seek to further minimize U.S. taxes by paying deductible interest to the new foreign parent or its affiliates in the low-tax country.

Specifically, the regulations attempt to curb inversions and earnings stripping by doing the following:

  • Limiting inversions by disregarding foreign parent stock attributable to certain prior inversions or acquisitions of US companies (under section 7874);
  • Targeting transactions that increase related-party debt that does not finance new investment in the US (under section 385); and
  • Allowing the IRS on audit to divide a purported debt instrument into part debt and part stock (under section 385).

Read More

Academic Immersion

Editor’s Note: The Petrie-Flom Center is now accepting applications for Student Fellowships for the 2017-2018 academic year. See our website for more information about applying! 

Last week, the New England Journal of Medicine published a Perspectives article describing the “Immersion Day” it holds for its board members. On the Immersion Day, participants don scrubs and shadow front line employees across various parts of the hospital – this might include attending ICU rounds or observing a surgery. The day gives board members the opportunity to meet and engage with staff in a meaningful way as they go about their jobs, painting a vivid picture of the issues and concerns that arise on paper in the board room. In its third year, the program is a resounding success, garnering rave reviews from the trustees. In fact, the hospital has now created an Immersion Day for state policymakers.

Having worked as a clinician before moving into policy and research, this piece resonated deeply with me. I have found my clinical experience to be essential and formative for how I view policy questions. In addition, as I approach the end of my year as a student fellow, I realized that this piece and the concept of immersion describes my experience with the Petrie-Flom Center. Read More

From Chance to Choice to Court

[Cross-posted from the Huffington Post Blog]

By Dov Fox

It used to be that whether you got the child you wanted — or one you hadn’t planned on — was left to cosmic fate or the randomness of reproductive biology. Now, new powers of reproductive medicine and technology promise to deliver us from the vagaries of the natural lottery.

The likes of voluntary sterilization and embryo screening give people who can afford them greater measures of control over procreation. Except, that is, when reproductive professionals make mistakes that frustrate efforts to pursue or avoid pregnancy or parenthood.

When, for example — just a few recent cases — a pharmacist fills a woman’s birth control prescription with prenatal vitamins. Or when a fertility clinic implants embryos carrying the hereditary disease that a couple underwent in vitro fertilization (IVF) to screen out. Just this week comes another report of losing IVF embryos.

Read More

Additional Troubles for Theranos

By Katherine Kwong

The onslaught of bad news for Theranos, the start-up laboratory services company plagued with troubles since last October, continued this week with a new round of reports and press coverage. First, on March 28, the Journal of Clinical Investigation published an article that found that Theranos’ tests tended to produce more irregular results than those of two other laboratory services companies. Then, on March 31, an inspection report by the Centers for Medicare and Medicaid Services was released, revealing numerous problems at Theranos that led to quality control problems, possibly leading to inaccurate test results for patients. The article and report both raise additional questions about Theranos’ claims and long-term viability – a steep letdown from early hype about the company, which promised to revolutionize the laboratory testing industry. The story of Theranos’ troubles highlights how scientific flaws and regulatory mishaps can lead to serious problems for companies seeking to innovate in the health sciences space.

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Monday, 4/4, HLS Health Law Workshop with Nicolas Terry

HLS Health Law Workshop: Nicolas Terry

April 4, 2016 5:00 – 7:00 PM
Hauser Hall 105
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA 02138

Download the Presentation: “Regulatory Disruption and Arbitrage in Healthcare Data Protection”

Nicolas P. Terry is the Hall Render Professor of Law at the Indiana University Robert H. McKinney School of Law. He serves as Executive Director of the Hall Center for Law and Health. Professor Terry teaches Torts, Products Liability, Health Information Technology, Law & Science, and Health Care Quality.

Educated at Kingston University and the University of Cambridge, Professor Terry began his academic career as a member of the law faculty of the University of Exeter in England. He has served as a Senior Fellow at Melbourne Law School and held visiting faculty positions at the law schools of Santa Clara University, the University of Missouri-Columbia, Washington University, and the University of Iowa. From 2000-08, Professor Terry served as co-director of Saint Louis University’s Center for Health Law Studies. From 2008-10, Terry served as the School of Law’s Senior Associate Dean.

Professor Terry’s research interests lie primarily at the intersection of medicine, law, and information technology. He is a permanent blogger at the HealthLawProf Blog and at Harvard Law School’s Bill of Health.  Professor Terry is also is the co-presenter of the “The Week in Health Law” podcast.