Human Rights Advocacy under Attack

One of the world’s most important human rights law firms is now under attack from a government whose leader has, to put it mildly, a mixed record on human rights.  The firm is the Lawyer’s Collective, which has done some of the most important work within India on HIV, LGBT and gender issues.  The firm’s lawyers have also made great contributions internationally. Indira Jaising has served as a member of the UN Committee on the Elimination of Discrimination Against Women. Anand Grover was the UN Special Rapporteur on Right to Health from 2008 to 2014, during which service he issues several fearless reports that helped move the world forward towards an enabling environment for HIV among the most legally marginalized people.

On June 1, the Indian Union Ministry for Home Affairs suspended the firm’s license to receive foreign funding, contending that the Lawyer’s Collective had violated the Foreign Contribution Regulation Act. The Lawyer’s Collective faces the prospect of having their license cancelled permanently, which would seriously impact their work. Both the suspension order and the Lawyer’s Collective’s response have been widely reported in the Indian media. Continue reading

Are The FDA’s New Definitions And Labeling Requirements Good For Us, Or Just Empty Calories?

By Diana R. H. Winters

[Crossposted from the Health Affairs Blog]

The Food and Drug Administration (FDA) has recently taken three steps toward providing consumers with more and better information about food products that the agency regulates. First, in response to several citizen petitions, the agency requested comments on the use of the term “natural” on food labeling. Second, the agency issued a statement in early May indicating that “in the near future” it planned to solicit comments reevaluating how nutrient content claims are regulated — including the term “healthy.” And third, the agency issued a final rule on an updated Nutrition Facts label, with which large companies must comply by July 2018.

With each of these actions the FDA is attempting to ensure that information provided to consumers by food manufacturers comports with the latest scientific understanding about food components. Indeed, the updated nutrition facts label will provide important information and potentially allow consumers to make more informed choices about what they eat. The agency, however, has set itself a far trickier task in defining words such as “natural” and “healthy.”

Act Naturally

In the past, the FDA has repeatedly declined to define the term “natural.” The Nutrition Labeling and Education Act (NLEA) of 1990 required the FDA to standardize definitions for nutrient content claims, like “fat free” or “high in fiber,” and to limit the use of health claims, like “heart healthy” (21 U.S.C. §§ 343(r)(1)(A), (B)). The word “natural,” however, does not fit into either of these categories.

Continue reading

New Resource: BPCIA Legislative History Documents

The Petrie-Flom Center is pleased to announce the availability of a new resource on its website: the legislative history of the Biologics Price Competition and Innovation Act (BPCIA).  The BPCIA, passed as part of the Affordable Care Act (ACA), created a pathway for the approval of biosimilar products and awarded innovator biologic companies twelve years of exclusivity for their products.  Modeled after the Hatch-Waxman Act of 1984, which established our system of generic small-molecule drug approvals while simultaneously creating a five-year period of exclusivity for new drugs, consideration of the BPCIA’s history is often lost in the discussion over the ACA’s history as a whole.  This resource selects only those documents relating to the BPCIA and may thus prove particularly useful for scholars of FDA law.

This new resource comes at an opportune time, as the courts and Congress have both turned their focus to the provisions of the BPCIA.  In 2015, the Federal Circuit issued a divided opinion interpreting the BPCIA’s instructions to biosimilar and innovator drug sponsors, and that opinion has now been appealed to the Supreme Court.  Just last month, the Justices called for the views of the Solicitor General on this question, a step which may significantly increase the likelihood of an eventual cert grant.  At the same time, several members of Congress have introduced a bill that would decrease the BPCIA’s grant of exclusivity from twelve years to seven years, bringing it more in line with the five-year period in the Hatch-Waxman Act or seven-year period in the Orphan Drug Act.  The twelve-year period of exclusivity may have been the most contentious aspect of the BPCIA as passed, with even the FTC arguing strongly against such a lengthy period at the time.

Members of the public may also be interested in an article written by Professor Erika Lietzan and colleagues providing an excellent analysis of the BPCIA’s legislative history.

National Academies Report Recommends Withdrawing the NPRM and Calls for a New Belmont Report

[Crossposted from Ampersand – The PRIM&R Blog]

By Elisa A. Hurley

On June 29, the National Academies of Science, Medicine, and Engineering released Part 2 of their report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. The report, written by the Committee on Federal Research Regulations and Reporting Requirements in response to a Congressional request, examines the impact of regulations and policies governing federally funded academic research in the United States. Part 1, released in September 2015, concluded that the continued expansion of federal regulations is “diminishing the effectiveness of the U.S. research enterprise, and lowering the return on federal investment in basic and applied research by diverting investigators’ time and institutional resources away from research and toward administrative and compliance matters” (xii). It made specific recommendations to reduce regulatory burden, and also recommended the creation of a “public-private Research Policy Board to streamline research policies.”

Part 2 concludes the analysis of regulations governing federally funded research and includes, in Chapter 9, a critical examination of the ethical, legal, and regulatory framework for human subjects research. The chapter begins by acknowledging that the research landscape has changed dramatically since the publication nearly 40 years ago of the Belmont Report, which established the three basic principles that provide the ethical foundation for the conduct of human subjects research in the United States. Changes in research methodologies and technologies, including comparative effectiveness research, research on de-identified biospecimens, observational studies of large datasets, cluster randomized trials, and research in emergency settings—as well as longstanding questions about the applicability to social and behavioral research of rules written for the biomedical research context—raise challenging questions about how to apply and balance the Belmont principles of respect for persons, beneficence, and justice across much of today’s research enterprise. Continue reading

Tort Reform in Oregon: Constitutional, After All?

By Alex Stein

Three years ago, Oregon’s Supreme Court voided the state’s $500,000 cap on noneconomic damages for medical malpractice for violating the constitutional guarantee that “In all civil cases the right of Trial by Jury shall remain inviolate” (Or. Const., Art. I, § 17, as interpreted in Lakin v. Senco Products, Inc., 987 P.2d 463, modified, 987 P.2d 476 (Or. 1999)). Klutschkowski v. Oregon Medical Group, 311 P.3d 461 (Or. 2013). This cap also clashed with “every man’s” right to “remedy by due course of law for injury done him in his person, property, or reputation” (Or. Const., Art. I, § 10, as interpreted in Smothers v. Gresham Transfer, Inc., 23 P.3d 333 (Or. 2001), and in Hughes v. PeaceHealth, 178 P.3d 225 (Or. 2008)). The Court reasoned that a person’s right to recover full jury-assessed compensation for injuries recognized as actionable in 1857, when Oregon adopted its constitution, cannot be abolished or abridged by statute or common law. For my discussion of the Klutschowski decision, see here. For my discussion of a similar entrenchment principle adopted by the Utah Supreme Court in Smith v. United States, 356 P.3d 1249 (Utah 2015), see here.

The Oregon Supreme Court has now changed this course in a long precedential decision, Horton v. Oregon Health and Science University, — P.3d —- 359 Or. 168 (Or. 2016). Continue reading

Mehrsa Baradaran on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Listen here!

Our guest this week is Mehrsa Baradaran, J. Alton Hosch Associate Professor of Law at the University of Georgia. Author of the acclaimed book How the Other Half Banks, Baradaran described the increasingly difficult financial landscape for poorer Americans. We discussed the impact of inequality and financial exclusion on many aspects of health care finance, including providers’ collections policies, hospital-as-lender models, and high-deductible health plans. Baradaran offers many important insights on how new financial realities affect both monetary flows and consumer protection in health care.

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 Radio, Tunein 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