Antibiotic Resistance and the GAIN Act
This week’s New Yorker has an interesting article on the rise of antibiotic resistant gonorrhea (subscription required). What caught my attention was its discussion of something called the GAIN Act...
View ArticleThe Significance of Statistical Significance
Early last month, Public Citizen, a non-profit devoted to “safeguarding individual rights and promoting public health and safety,” filed a lawsuit against the FDA regarding the Agency’s approval of...
View ArticleCompounding Laboratories, Fungal Meningitis, and Federalism
Last week’s news saw an outbreak of stories concerning meningitis-contaminated steroid injections. According to reports, the outbreak has been traced to New England Compounding Center, a “compounding...
View ArticleBioSci-Fi: Do Androids Dream of Electric Sheep?, Philip K. Dick, 1968
“If you dial,” Iran said, eyes open and watching, “for greater venom, then I’ll dial the same. I’ll dial the maximum and you’ll see a fight that makes every argument we’ve had up to now seem like...
View ArticleAmgen Buys DeCODE – Reflections Backwards, Forwards, and on DTC Genomics
Earlier this week, U.S. biotech giant Amgen announced it was buying DeCODE Genetics for $415 million, thus apparently ending that company’s “interesting” 16 year ride. See this article in Genome Web...
View ArticleStanding, the FDA, and Dial Soap
When I hear, “FDA,” I generally think of the government regulator of serious, potentially dangerous drugs: thalidomide, fen-phen, tasmar. I typically don’t think of hand soap. But if you, like millions...
View ArticleCline v. Oklahoma Coalition for Reproductive Justice: A Fascinating Supreme...
Just before recessing for the summer, the Supreme Court issued an unusual order in Cline v. Oklahoma Coalition for Reproductive Justice. The Court’s order reads, in full: The petition for a writ of...
View ArticleThe FDA Drops an Anvil on 23andMe – Now What? (slightly revised Wed. night)
On Friday, November 22, the FDA sent a nastygram to 23andMe, the only remaining substantial pillar of the “direct to consumer” (DTC) genomic testing industry. The letter, available here, is well worth...
View ArticleTo Inform Policy on Consumer Genomic Tests, Go Empirical
By Roland Nadler, 2L, Stanford Law School, Student Fellow, CLB As many of our readers will know, last week the Food and Drug Administration let the regulatory hammer fall on 23andMe, last of the major...
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