Category: Public Health

Petrie-Flom Intern’s Weekly Round-Up: 12/1-12/8

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By Chloe Reichel

1) Following orders from FDA, 23andMe will no longer market genetic tests using health analyses. The company will, however, continue to sell genetic tests related to ancestry.

2) Families with children who have seizure disorders are flocking to Colorado. There, these children can legally receive medications containing extracts from marijuana, which are believed to reduce the occurrence of seizures.

3) A bill is being debated in the New York City Council that would ban the use of electronic cigarettes in public spaces. Supporters of the ban say that electronic cigarettes pose a public health risk, while opponents say that they are harmless.

4) Chemotherapy will not be forced on an Amish girl with lymphoblastic lymphoma. The family decided to stop treatment because of the side effects, and the court-appointed guardian of the girl has decided to drop the case against her parents because they are not locatable.

5) Error rates for those who filled out enrollment forms on the Healthcare.gov online insurance marketplace were at 25 percent for October, although representatives say that these error rates have since declined.

6) Legislators who are opposed to the Affordable Care Act are planning to utilize funds allocated by the federal government for Medicaid expansion to instead purchase private health insurance plans for people who are of low socioeconomic status. This Friday, Tom Corbett, governor of Pennsylvania announced this plan, and Arkansas legislators have already enacted an analogous plan.

Challenges to Third-Party Food Safety Audits and Certification

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By Ching-Fu Lin

About a month ago, Jensen Farms pleaded guilty to federal criminal charges for introducing adulterated food into the nation’s food supply via interstate commerce.  In 2011, cantaloupes produced by Jensen Farms resulted in a listeria outbreak that spread across 28 states, killed 33 people, and sickened hundreds.  The now bankrupt and out of business owners—brothers Eric and Ryan Jensen—are to be sentenced in January 2014.

The Jensens took responsibility for one of the deadliest food safety outbreaks in the United States, but they also turned around to sue Primus Labs, a food safety audit firm.  The brothers allege that Primus Labs acted negligently, breached its contractual obligations, and engaged in deceptive trade practices in performing third-party audits on the farmlands and packing house.  Merely weeks before the outbreak, Primus Labs sent one of its subcontractors (Bio Food Safety) to Jensen Farms to perform a third-party audit.  After the audit, Bio Food Safety gave Jensen Farms a “superior” rating with an almost impeccable score of 96 out of 100, which was later found by the Food and Drug Administration (FDA) to be “seriously deficient in its inspection and findings.”  As claimed by the Jensens, Bio Food Safety failed to observe several practices that were in violation of Primus Labs’ standards and relevant FDA guidelines or to inform them of any microbiological risk.  Despite these deficiencies, Jensen Farms cantaloupes were “Primus Certified” and entered into the retail market.

The Jensen Farms case raises questions on the credibility of third-party audits and certifications in the area of food safety.

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A “Torrent of Studies” on Direct-to-Consumer Advertising: Is FDA Shoring Up Its Defenses?

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By Kate Greenwood

Cross-Posted at Health Reform Watch

At Regulatory Focus earlier this week, Alexander Gaffney wrote about what he characterized as “a torrent of studies” that FDA is conducting or has proposed conducting on prescription drug promotion, and, in particular, on direct-to-consumer advertisements.  The studies include, among others, a survey study aimed at sussing out “the influence of DTC advertising in the examination room and on the relationships between healthcare professionals and patients”, a study exploring similarities and differences in the responses of adolescents and their parents to web-based prescription drug advertising, and a study that will use eye tracking technology to collect data on the effect of distracting audio and visuals on participants’ attention to risk information. 

Gaffney speculates that “the proposed studies could indicate coming changes in FDA’s regulatory approach toward advertising[.]”  Another possibility is that the studies are part of an effort by FDA to build up the evidence base supporting its current regulatory approach.  In a Tweet commenting on Gaffney’s article, Patricia Zettler–a  Fellow at Stanford Law School’s Center for Law and the Biosciences who was formerly an Associate Chief Counsel for Drugs at FDA’s Office of Chief Counsel–asks whether the data generated by the studies could help insulate FDA from First Amendment challenges. Read More

DUE MONDAY: Call for Abstracts for Petrie-Flom Center 2014 Annual Conference

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The Petrie-Flom Center invites abstracts for its 2014 Annual Conference: “Behavioral Economics, Law, and Health Policy.” The conference will be held at Harvard Law School on May 2 and 3, 2014, and seeks to address the following questions:

  • Are there features unique to health and health care that prevent individuals, groups, and policymakers from making the best decisions?  What is a “best” decision, i.e., whose perspective should be paramount?
  • What types of barriers exist to rational decision making in the health care context, and what does rational decision making look like here?
  • Is exploitation of framing effects, default rules, nudges, and other elements of choice architecture appropriate when it comes to human health, or is this an area where pure autonomy should reign – or perhaps strong paternalism is needed? Is health policy special?
  • What should policymakers do when there is conflict between outcomes that might be good for individuals but not society more generally, and vice versa?  Where should the nudges push?
  • Which areas of health law, bioethics, and biotechnology policy are most amenable or resistant to manipulation of choice architecture?  When nudges are not plausible, what is the best way to overcome bounded rationality?
  • When might behavioral economics lead to the wrong results for health law, bioethics, and biotechnology policy?
  • How can manipulations of choice architecture be best evaluated empirically, and what ethical concerns might such research raise?
  • What are the most interesting or compelling health law, bioethics, and biotechnology policy nudges we should be thinking about today in the realms of obesity, organ donation, end-of-life care, biospecimen ownership and research, human subjects research, HIV testing, vaccination, health insurance, and other areas?

Please note that this list is not meant to be at all exhaustive; we hope to receive papers related to the conference’s general theme but not specifically listed here.

Calls for abstracts are due by December 2, 2013.

For a full conference description, including the call for abstracts and registration information, please visit our website.

Only a Right to Health

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By Nathaniel Counts

Human rights disaggregates otherwise related issues into separate rights.  We discuss rights to health, education, housing, association, etc., and, in countries where these rights are codified, we litigate each one separately in the courts.  We also know that each of these issues for which there is a corresponding right is, to some extent, a symptom of poverty.  In some cases it might not be possible to treat the symptoms without addressing the root cause.  For example, in 1966, the Coleman study on equality in education found that “[s]chools bring little influence to bear on a child’s achievement that is independent of his [or her] background and general social context.”  These findings have been contested, but it is likely that socioeconomic factors are a determinant of a child’s academic success, along with the educational experience itself.  If the socioeconomic background is the greater determinant, it may not make sense to use scarce government resources to fund school improvement rather than addressing poverty itself.  In a country with a right to education, school improvement could be litigated and potentially derail national efforts to address root causes.

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DUE IN ONE WEEK: Call for Abstracts for Petrie-Flom Center 2014 Annual Conference

The Petrie-Flom Center Staff Leave a comment

The Petrie-Flom Center invites abstracts for its 2014 Annual Conference: “Behavioral Economics, Law, and Health Policy.” The conference will be held at Harvard Law School on May 2 and 3, 2014, and seeks to address the following questions:

  • Are there features unique to health and health care that prevent individuals, groups, and policymakers from making the best decisions?  What is a “best” decision, i.e., whose perspective should be paramount?
  • What types of barriers exist to rational decision making in the health care context, and what does rational decision making look like here?
  • Is exploitation of framing effects, default rules, nudges, and other elements of choice architecture appropriate when it comes to human health, or is this an area where pure autonomy should reign – or perhaps strong paternalism is needed? Is health policy special?
  • What should policymakers do when there is conflict between outcomes that might be good for individuals but not society more generally, and vice versa?  Where should the nudges push?
  • Which areas of health law, bioethics, and biotechnology policy are most amenable or resistant to manipulation of choice architecture?  When nudges are not plausible, what is the best way to overcome bounded rationality?
  • When might behavioral economics lead to the wrong results for health law, bioethics, and biotechnology policy?
  • How can manipulations of choice architecture be best evaluated empirically, and what ethical concerns might such research raise?
  • What are the most interesting or compelling health law, bioethics, and biotechnology policy nudges we should be thinking about today in the realms of obesity, organ donation, end-of-life care, biospecimen ownership and research, human subjects research, HIV testing, vaccination, health insurance, and other areas?

Please note that this list is not meant to be at all exhaustive; we hope to receive papers related to the conference’s general theme but not specifically listed here.

Abstracts are due by December 2, 2013.

For a full conference description, including the call for abstracts and registration information, please visit our website.

New Data on Drug Overdose Law

Temple University Center for Public Health Law Research Leave a comment

By Scott Burris

Working with Corey Davis of the Network for Public Health Law, PHLR has completed and posted updated longitudinal datasets of state laws authorizing naloxone distribution and creating “Good Samaritan” immunity for callers reporting a drug overdose to 911. Take a look at www.lawatlas.org.

On the theory that an image beats a few hundred words, here’s a report on the state of the law:

FSMA Proposed Rule on Accreditation of Third-Party Auditors

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By Ching-Fu Lin

Earlier this year, the Food and Drug Administration (FDA) published for public comment the proposed rule to implement §307 of the FDA Food Safety Modernization Act (FSMA).  The proposed rule is to establish a program for accreditation of third-party auditors to provide the FDA with a more efficient tool to regulate food products.  Particularly, it assists the FDA in regulating food entering the United States via international trade, as it is recognized by the FSMA that the FDA is administratively and financially unable to ensure the safety of imported foods solely on its current system of border inspection.  Under the new program, the FDA would recognize accreditation bodies, which would in turn accredit third-party auditors.  These third-party auditors would then conduct onsite food safety audits in foreign jurisdictions and issue certifications for foreign food producers.  According to the FSMA and the proposed rule, an accreditation body can be a foreign government/agency or a private third party, and a third-party auditor can be a foreign government, foreign cooperative, or a private third party.  Both are required by the proposed rule to meet standards for legal authority, competency and capacity, impartiality/objectivity, quality assurance, and records procedures.

Will such a multilayer delegation structure result in dilution of accountability and effectiveness?

Congress -> FDA -> Accreditation Body -> Third-Party Auditor -> Producer

The FSMA seems to have created a regulatory dilemma for the FDA in terms of addressing imported food safety.  The dilemma results from a structural mismatch between the broad scope of power granted to the FDA and the long chain of delegation to foreign/private actors as primary “regulators.”  The FSMA instructs the FDA to delegate its regulatory authority to foreign governments and/or private third parties, aiming to largely increase the effectiveness of regulation along the global supply chain. However, the FSMA does not give the FDA adequate capacity to closely oversee such foreign/private regulatory agents along the delegation chain.  Thus, the FSMA cannot hold foreign/private regulatory agents fully accountable for their failures in ensuring food safety.

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Video now available of panel on “Reproductive Rights around the Globe”

The Petrie-Flom Center Staff Leave a comment

Video of the panel discussion “Reproductive Rights around the Globe,” held at Harvard Law School on November 7, is now available via the Petrie-Flom Center’s website. The panel — cosponsored by the Petrie-Flom Center; the Human Rights Program; and the Child Advocacy Program at Harvard Law School; and the Harvard Global Health Institute — included legal experts on a variety of topics:

  • International trends in gamete donor identifiability v. anonymity – I. Glenn Cohen, Professor of Law, Harvard Law School; Faculty co-Director, Petrie-Flom Center
  • The politics of evidence and expertise in domestic and international abortion litigation – Aziza Ahmed, Associate Professor of Law, Northeastern University School of Law; Visiting Scholar, Petrie-Flom Center (Spring 2014)
  • Use of international fora, including courts and treaty bodies, to advance reproductive rights – Mindy Jane Roseman, Lecturer on Law, Harvard Law School; Academic Director, Human Rights Program
Link to the video here.