Thursday, August 18, 2011
At the request of the Petrie-Flom Center, I am posting this announcement:
"The Petrie-Flom Center is an interdisciplinary research program at Harvard Law School dedicated to scholarly research at the intersection of law and health policy, including issues of health care financing and market regulation, biomedical research and bioethics. The Academic Fellowship is a postdoctoral program specifically designed to identify, cultivate and promote promising scholars early in their careers. Fellows are selected from among recent graduates, young academics and mid-career practitioners who are committed to spending two years at the Center pursuing publishable research that is likely to make a significant contribution to the field of health law policy, medical innovation policy or bioethics. Our prior fellows have found employment as law professors at Harvard, UC Berkeley, BU, UCLA, Cornell and the University of Arizona. More information on the Center can be found here."
"Petrie-Flom fellowships are full-time, two-year residential appointments offering a $60K annual stipend and other research support. Fellows devote their full time to scholarly activities in furtherance of their individual research agendas. The Center does not impose teaching obligations on fellows, though in appropriate cases voluntary teaching opportunities may be made available. For further information on the program and eligibility requirements, please see the full Call for Applications here. Completed applications must be received by 9:00 a.m. on November 14, 2011." (FP)
Nathan Cortez, Can Speech by FDA-Regulated Firms Ever be Noncommercial? SSRN/AJLM
Tim Vogus et al, Doing No Harm: Enabling, Enacting, and Elaborating a Culture of Safety in Health Care, SSRN
Anupam B. Jena et al, Malpractice Risk According to Physician Specialty, NEJM
Amanda C. Pustilnik, Pain as Fact and Heuristic: How Pain Neuroimaging Illuminates Moral Dimensions of Law, SSRN/Cornell L.Rev.
Wednesday, August 17, 2011
Not surprisingly, especially after the Supreme Court's decision in Sorrell v. IMS Health, major tobacco companies have challenged the FDA's new graphic warnings for cigarette packs. But even with the Court's heightened scrutiny for regulations of commercial speech, the FDA should prevail. The Court has clearly distinguished between restrictions of speech and mandatory disclosures that are designed to ensure that the public is not misled. Indeed, just last year, in Milavetz, the Court upheld required disclosures for professionals providing consumer assistance with bankruptcy proceedings. Pharmaceutical manufacturers still must disclose side effects of their drugs after Sorrell, and tobacco companies will have to provide adequate warnings about the risks of cigarette smoking.
Tuesday, August 16, 2011
Many health and environmental groups are urging the Environmental Protection Agency to regulate perchlorate in drinking water. According to the Environmental Working Group report, perchlorate, the main ingredient of rocket and missile fuel, contaminates drinking water supplies, groundwater or soil in hundreds of locations in at least 43 states. EWG estimates that the drinking water of 20 million Americans is affected. The Environmental Protection Agency has not yet set a standard for this chemical under the Safe Drinking Water Act.
On October 10, 2008, the EPA published a preliminary determination not to regulate perchlorate, but after receiving comments, has been reconsidering whether to regulate ever since. In 2009 EPA requested more comments in a supplemental request. In July, EPA Deputy Administrator Robert Perciasepe was encouraged to move forward with the regulation during a Senate Environment and Public Works Committee hearing. According to the environmental news reporting service Greenwire, industry opposes regulation by claiming exposure to low levels of the chemical are not harmful, and that reports of widespread contamination are due to improvements in perchlorate detection that can find even trace -- and safe -- amounts of the chemical in water. However, a number of studies suggest otherwise, including those used by the California Department of Public Health to justify regulating the chemical in its state program.
Perchlorate is a specific example of one of EPA’s failure to identify and regulate contaminants under the SDWA, a failure documented by the General Accounting Office in a report entitled EPA Health Risk Assessments issued in July. Like so many of the regulatory efforts I have mentioned here this year, the costs of protecting the public health are again pitted against raising the costs of doing business. Not surprisingly, the next step in the process is for EPA to scrutinize how regulating perchlorate will affect business. EPA is required now to form a small business advocacy review (SBAR), consisting of obtaining comments from “small entity representatives” (SERs) when drafting a rule that could have a "significant economic impact." SERs are selected from government, nonprofits and businesses. Bigger businesses and other entities will continue to provide input during the formal notice and comment periods, but this step will reinforce EPA’s mandate to focus more closely on the economic impacts of decisions purported to be for the benefit of public health.
Monday, August 15, 2011
For some time the FDA has been working on guidelines relating to the "Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools." Along the way there have been public hearings, here, and missed deadlines, here. In the meantime pharmaceutical companies have been able to promote their wares online in relative safety thanks to a safe harbor provided by Facebook. Specifically, Facebook allowed pharmaceutical product pages to have comments turned off. Starting today that privilege has been revoked and the drug pages must have "open" Walls. The issues that arise are comprehensively explored by Christian Torres in the Washington Post, here. In brief, allowing others to inject praise on a drug's page could upset the FDA's requirement that marketing be balanced and, potentially, open the door to users posting about off-label uses, and impacting the manufacturer's duty to report adverse events (presumably by requiring proactive monitoring of critical posts). Given that there is something of a regulatory vacuum, product pages are disappearing faster than you can click "like." There is even a "Deathwatch" site, here, that is keeping track of the pages that the pharmaceutical companies have taken down. [NPT]
Sunday, August 14, 2011
El 6 de Agosto
Greetings from Indianapolis (alas not Puerto Vallarta)!!
This is my last blog on health care in Mexico and North America. In this blog, I want to talk about the implications of free trade agreements for the health care sectors of the three countries of North America – The United States, Canada and Mexico.
In 1947, twenty-three countries agreed to the General Agreement on Tariffs and Trade (GATT) to promote free trade in the world. Initially, GATT only addressed trade in goods. However, since the Uruguay Round in 1994, the General Agreement on Trade and Services (GATS) also addresses trade in services, capital, and intellectual property. The trade agreements in the Uruguay round also established the World Trade Organization. (World Trade Organization, Legal Texts).
The basic theory of free trade agreements is that free trade among private persons and enterprises is to be promoted and, as a corollary, public monopolies providing goods and services are to be discouraged. This theory is at odds with the state of affairs in almost every national health care sector in the world. In these health care sectors, private actors have demonstrated that they are not able to provide affordable and high quality health care services for all in need. In almost every country of the world, states have had had to subsidize health coverage for certain segments of the population – namely, the elderly, disabled and poor. Often this subsidy is accomplished through a public health insurance program.
The impact of free trade agreements on the accessibility and affordability of health care services is a concern in the three countries of North America with their varied health care systems. As discussed in prior blogs, the three health care sectors of North America are quite different and independent. Canada has an established public universal health insurance program. The US health care sector is undergoing reform to address major gaps in health coverage. Mexico too is expanding coverage in its less modern but advancing health care sector.
Guest Blogger J. Janewa OseiTutu: Public Health and Intellectual Property - Seizure of Generic Drugs in Transit
In May 2010, Brazil and India filed complaints against the European Union (“EU”) and the Netherlands at the World Trade Organization (“WTO”) over the confiscation of generic drugs in transit. A settlement of the dispute between India and the EU was announced at the end of July 2011.
The EU border seizures were part of its intellectual property enforcement program. The drugs in question were not patent protected in either the point of origin or the final destination. Brazil and India cited a number of provisions under the WTO Agreement on Trade-Related Intellectual Property Rights (“TRIPS”) and the General Agreement on Tariffs and Trade (“GATT”) in support of their complaints. In its WTO request for consultations, pursuant to the WTO Understanding on Rules and Procedures Governing the Settlement of Disputes (“DSU”), Brazil complained about the confiscation by Dutch authorities of a shipment of a generic drugs from India that were destined for Brazil. The shipment was seized in Amsterdam and returned to India. Brazil complained that many similar shipments had been seized while in transit through the Netherlands and alleged inconsistency with TRIPS and GATT. Similarly, India complained about the Dutch seizures of generic drugs originating from India and destined for developing countries like Nigeria and Peru.