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Archive for February, 2010

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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Per our class discussion on Thursday, today’s article in the New York Times highlights several legal and regulatory issues FDA is confronting about nutritional information and serving sizes.  The video posted for the article demonstrates some of these issues.  Is current food labeling misleading?  Does FDA need to tighten its regulations, or merely enforce the current requirements?

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