Category: FDA

The Impact of FSMA Import Rules on Domestic Suppliers

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By Ching-Fu Lin

The Food and Drug Administration’s (FDA) proposed rule on Accreditation of Third Party Auditors to implement the Food Safety Modernization Act (FSMA) has given rise to many questions on both domestic and international levels.  The proposed rule is intended to establish a program for recognition of accreditation bodies and accreditation of third-party auditors to provide the FDA with a more efficient tool to regulate imported food products.  In this regard, §307 of the FSMA and its implementing rule are generally seen as necessary to assist the FDA in regulating food imported from foreign jurisdictions, as the FDA is currently administratively and financially unable to ensure import safety on its own.

Again, the proposed rule on Accreditation of Third-Party Auditors is designed to cope with import food safety, and works in an inter-related manner to another proposed rule for Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals.  However, many have expressed concerns about the possible trend toward  such “import” rules – which embrace private regulatory participation – becoming de facto “domestic” rules.  Although the legal effects of private certification against FDA standards of domestic products are yet to be clarified, the FDA indicated that such an introduction of rules to the domestic sphere may be desirable in the proposed rule on Accreditation of Third-Party Auditors:

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How Drug Samples Are Being Used to Fight the Good Fight

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By Deborah Cho

I would highly recommend reading the Stanford Social Innovation Review’s recent article An Rx for Surplus Meds featuring the Dispensary of Hope, a brilliant model of providing prescription medications to those who need but can’t afford them.

In a nutshell, the Dispensary of Hope, a not-for-profit enterprise, collects unused medication samples from participating physicians and pharmacies across the country and redistributes those medications to safety-net health centers.  Those health centers can then prescribe these much-needed medications to patients who are unable to obtain them otherwise.  Since many of those medications would likely sit on shelves until they had to be discarded if they were not donated, this is beneficial to both the physician practices that no longer have to worry about proper drug sample disposal and also to safety-net health centers and their patients.

More specifically, participating physician practices and pharmacies simply fill with medications the boxes that are shipped to them by the organization and then ship the box back to the organization’s headquarters.  The organization’s staff and volunteers there do all the legwork necessary to properly inventory the drugs so that they can be distributed.  This way, time and effort required on the parts of these physician and pharmacy groups is minimal (not to say that their contribution is minimal – the Stanford article states that $14 million of sample donations were expected for 2013).  The organization thus provides a missing link, acting as an intermediary between the donors and the recipients to keep the supply constant and regular.

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REGISTER NOW: “New Directions for Food Safety” conference at Harvard Law School

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This conference will bring together scholars to discuss a range of issues related to the Food Safety and Modernization Act, including FSMA and risk regulation strategy; regulating farm production; benefits, challenges, and gaps in FSMA’s approach; and international issues and trade implications.

Speakers include:

  • KEYNOTE: Peter Barton Hutt, Harvard Law School/Covington & Burling – The Food Safety Modernization Act in Historical Perspective

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New Book: “Science and Technology in International Economic Law”

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I am pleased to post that my new book, “Science and Technology in International Economic Law: Balancing Competing Interests” (co-edited with Professor Bryan Mercurio at the Chinese University of Hong Kong), was recently published by Routledge. In addition to the introduction, the book includes thirteen articles written by scholars from the Asia-Pacific region, Middle East, and Europe. It is the first attempt to explore the status and interaction of and between science, technology and international economic law (namely, trade and investment) with a view to seeking a proper balance between promoting trade/investment liberalization and ensuring that decisions are soundly based and that technological advancement is not hampered.

On the issue of food safety, scientific evidence and trade disputes, I contributed a paper, titled ”Does Science Speak Clearly and Fairly in Trade and Food Safety Disputes? The Search for an Optimal Response of WTO Adjudication to Problematic International Standard-Making,” which appeared previously in the Food & Drug Law Journal, Vol. 68, pp. 97-114 (2013).

The following reveals a brief background and objective of the book:

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Antibiotics in Livestock

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Last week, the Food and Drug Administration finalized a long-awaited guidance document that aims to reduce non-therapeutic uses of antibiotics in livestock production and thereby limit the evolution of drug-resistant bacteria.

As I discussed in a previous post, the use of antibiotics in livestock production is often not for the therapeutic purpose of curing disease, but rather for the purpose of speeding growth or increasing feed efficiency.   Current estimates are that livestock production consumes 30 million pounds of antibiotics per year, representing 80 percent of the total volume of antibiotics sold in the United States for any purpose.  The FDA policy that allows non-therapeutic uses of antibiotics in livestock has in recent years been subject to intense scrutiny by outside advocates, former FDA officials, government investigators, and judges.

The FDA has now taken action to address these concerns by finalizing industry guidelines that it first proposed over a year ago.   Under the guidelines, animal pharmaceutical companies would change the labeling of “medically important” antibiotics in two ways.  First, the labeling would no longer list production uses (i.e., growth enhancement and feed efficiency) in the approved uses for the drugs.  Second, the labeling would require veterinary oversight for therapeutic uses (i.e., the prevention, control, or treatment of a disease), rather than allowing over-the-counter distribution.  These changes in labeling would in turn require changes in agricultural use by virtue of other FDA regulations that prohibit off-label use for production purposes.

While the FDA’s action is a step in the right direction toward eliminating non-therapeutic uses of antibiotics in food animals, there are a few features of its strategy that are worth highlighting as they might significantly limit its impact.     Read More

1/31: Second Annual Health Law Year in P/Review conference

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Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Read More

Conflicts of Interest and the FDA’s Determinations of Food Safety

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By Leslie Francis

At last year’s Petrie-Flom conference on the FDA in the 21st Century, I had an experience that I’ve never really had before in my academic career.  I gave a paper (co-authored, actually) that was met with genuine ire.  The paper dealt with labeling GMO foods.  Several in the audience—including friends—heard me as going over to the dark side of anti-science, irrational skepticism, and downright immoral ignorance of important nutritional and commercial advantages.  I wasn’t buying into such bad science, however.  The written paper (concededly it’s always possible that a lengthy legal argument doesn’t come across in a nuanced way in a short presentation) argued three points:  (1) the FDA has not acted to the full extent of its statutory labeling authority; (2) the present processes for granting market clearance for particular GMO products is highly deferential to industry submissions with respect to safety (the safety of a particular GMO product is a different question from the general question of GMO safety—the FDA’s own example is the unknown allergenic effects of adding peanut genes to other agricultural products); and (3) in a context in which scrutiny of safety is so industry-dependent, there is a case to be made for labeling so that consumers can make their own choices.

In a nutshell, the current FDA process for allowing a particular GMO product to be marketed is a variant of the process for allowing marketing of additives Generally Recognized as Safe (GRAS).  Under the GRAS process, anyone can petition for a determination that an additive is GRAS; industry can also make its own GRAS determinations.  The procedure for clearing GMO foods is a consultative process that is also voluntary and entirely reliant on information from industry.  Unlike the GRAS process, however, it does not even require publication of the information relied on for consultations.

In an article published this week in JAMA Internal Medicine, Neitner et al. demonstrate the extent to which GRAS determinations are riddled with conflicts of interest.  The authors conclude, “The lack of independent review in GRAS determinations raises concerns about the integrity of the process and whether it ensures the safety of the food supply, particularly in instances where the manufacturer does not notify the FDA of the determination. The FDA should address these concerns.”  Given the parallels between the GRAS process and the process applied to GMO foods, one might hypothesize that conflicts of interest are similarly present in the latter.  The FDA should address these concerns, too.  This is not anti-science; it is respect for good science.

[Leslie Francis]

The FDA Strikes Again: Its ban on home testing kits is, as usual, likely to do more harm than good

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Cross-post from PointOfLaw.

Richard A. Epstein is a professor of law at NYU Law School, a Senior Fellow at the Hoover Institution, a Senior Lecturer at the University of Chicago and a visiting scholar with the Manhattan Institute’s Center for Legal Policy. His forthcoming book is “The Classical Liberal Constitution,” from Harvard University Press.

On November 22, 2013, the Food and Drug Administration flexed its regulatory muscle by sending a warning letter to a genetic-testing company that goes under the stylish name of 23andme. The object of FDA scorn was a diagnostic kit that the tech company, backed by among others Google and Johnson & Johnson, sold to customers for $99. The kit contained an all-purpose saliva-based test that could give customers information about some 240 genetic traits, which relate to a wide range of genetic traits and disease conditions. The FDA warning letter chastised 23andme in no uncertain terms for being noncooperative and nonresponsive over a five-year period in supplying information that the FDA wanted to evaluate its product as a Type III device under the Medical Devices Act.

Legal Regulation of 23andme

There is no doubt that the FDA is on solid legal ground. This case is not like the processes involved in Regenerative Sciences, LLC v. United States, where the FDA asserted that physicians’ use of certain stem-cell procedures for joint disease involved the use of a drug that required FDA approval before it could be approved for use. In an earlier essay for the Manhattan Institute, I argued that this classification was in fact both legally incorrect and socially mischievous. In this case, the legal arguments are not available to 23andme because the current definition of “medical devices” covers not only those devices intended for use on the human body, but also those used for the diagnosis of disease. The Type III classification means that this device has to receive premarket approval from the FDA, which in turn requires that it be shown to be safe and effective for its intended use. Getting approval under this standard is arduous business, because any such approval must be for each of the tests separately. 240 tests thus require that number of approvals. The costs are prohibitive, and the delay enormous.

The FDA Warning Letter is significant both for what it says and for what it does not say. Read More

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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