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Not So Fast Pomegranate Juice

The FTC is in a kerfuffle with the manufacturer of Pom Wonderful, a pomegranate juice that claims several health benefits, like reducing the risk of heart disease, prostate cancer, and impotence — claims that the FTC thinks should be preapproved by the FDA.  The FTC recently has enunciated a stricter policy against deceptive advertising by food and dietary supplements.  Of course, Pom is challenging the action on First Amendment grounds.  This is a good example of how FTC and FDA jurisdiction intersect (somewhat) for consumer advertising (the FTC’s bailiwick) that makes health claims (the FDA’s bailiwick). [Thanks to Amanda Morin for the link]

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For the second class on dietary supplements on Tuesday, September 21st, please read the following documents about FDA’s objections to Del-Immune’s labeling.  Read the web site that gave rise to FDA’s warnings, then FDA’s Warning Letter, then Del-Immune’s response to FDA.  This is a great example of the materials we’ll be discussing, as well as how FDA communicates its objections and how companies respond.

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Welcome to the Food & Drug Law course at SMU Law School.  I’ll use this page to post news articles relating to the material we discuss in class, to show you ongoing examples of what we’re studying.  We can also use this space to continue our class discussions without using class time.

As noted in the Registrar’s announcement, please read pp. 3-27 of the coursebook for class Tuesday.

There is also a course reader available at AlphaGraphics (next to the SMU Bookstore) for around $20.  For Thursday, please read the readings designated for Class 2 (under Tab 2).  If you can’t buy the reader by Thursday, here are some links:

*      Advisers Say FDA’s Flaws Put Lives at Risk (N.Y. Times, 2007)

*      Skim:  FDA Science and Mission at Risk (FDA Science Board, 2007)

*      FDA Told U.S. Drug System Is Broken (Washington Post, 2006)

*      FDA Scientists Allege Mismanagement at Agency (CNN, 2009)

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For tomorrow’s class discussion, here’s a poignant article about the “wonders and brutality” of some medical devices, in this case, linear accelerators that deliver intensity-modulated radiation therapy (IMTR).  Remember, CDRH is the Center for Devices and Radiological Health.  Post your thoughts here before and after the class discussion on Tuesday.

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After considering the articles we read about off-label promotion, where do you stand on the FDA’s Guidance on Good Reprint Practices?  Do you agree with Rep. Waxman, or the FDA?  And after discussing this article about Medicare reimbursement for off-label prescriptions of cancer drugs, do you think the federal government should pay for off-label scripts (for cancer therapies or otherwise)?

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Ignore Expiration Dates?

Here’s an article on Slate.com, arguing that expiration dates are relatively worthless.  In general, expiration dates aren’t regulated by the FDA or any other federal agencies.  Some states regulate expiration dates for some foods, but there’s no national uniformity.  Should the FDA regulate expiration dates?  Could it?  Or should the FDA implement the author’s other suggestions (noted in the last paragraph)?

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For Tuesday’s class, please read the Warning Letter FDA sent to Del-Immune V, the web site at issue, and the company’s response letter.  Also, we are going to discuss Pearson v. Shalala (D.C. Cir. 1999), Whitaker v. Thompson (D.D.C. 2002), and the article about dietary supplements from Sports Illustrated, “What You Don’t Know Might Kill You.”  Update: Here are some of the sidebar stories from the print edition that are not part of the electronic version above: Rogues’ Gallery, and The FDA’s Burden.

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