- Watch on the rinds: consumers protest against Mimolette import ban [Cato interview with Jill Erber of Northern Virginia cheese shop Cheesetique, Katherine Mangu-Ward, Mark Steyn on French and U.S. attitudes toward cheese freedom, earlier here, etc.] “The Inside Story of a ‘Juror Revolt’ in Amish Raw Milk Trial” [Modern Farmer] History of Canadian margarine regulation [more from Steyn, NRO]
- Steve Chapman on the utopian quest for zero BAC driving [syndicated/Reason]
- “In addition to its constitutional flaws, California’s foie gras ban is unenforceable.” [Baylen Linnekin]
- Class actions vs. food and beverage defendants soar, “from roughly 19 cases in 2008 to more than 102 in 2012” [Reuters]
- Beware the kale: “The Terrible Tragedy of the Healthy Eater” [Erica, NW Edible Life]
- Culinary, legal, insurance and scientific aspects of roadkill [Edible Geography]
- “FDA And Caffeine: Selective Regulation By Unsubtle Threat” [Cory Andrews, WLF]
Posts Tagged ‘FDA’
Medical roundup
- New ACA regulations from the feds restrict employer wellness programs [Jon Hyman; Leslie Francis, Bill of Health]
- Frequent-flyer defense medical examiner comes to grief in New York [Eric Turkewitz]
- Fecal transplants (that’s not a misprint) appear to hold out hope of saving a lot of lives, except for the mountain of FDA paperwork blocking them [Amar Toor/The Verge, Maggie Koerth-Baker] Enter the grey market [Beth Skwarecki]
- Why can’t the FDA catch up with Europe on sunscreens? [Alex Tabarrok]
- “The banning of catastrophic-only plans infuriates me the most…. the only plans that are actually financially sensible for a healthy individual to purchase.” [MargRev comments section]
- More on the recent study of malpractice suits by a group of Johns Hopkins researchers [Christopher Robinette]
- For all his public health pretensions, Michael Bloomberg “has no idea what he’s talking about” on medical marijuana [Jacob Sullum]
- Another look at asylums? [James Panero, City Journal]
- Feds’ war on Google pharma ads reflects no credit on D.C. [Brian Doherty]
3-D printing: the legal dimension
The remarkable recent advances in make-it-yourself technology are opening up all sorts of new possibilities for users, but also have the potential to freak out the CPSC, FDA, trade agencies and intellectual property lawyers, as well as gun-control advocates. When products extruded from local printers are inevitably involved in injuries, which distant parties can be sued? [Bloomberg]
“21 to drink coffee?”
“The U.S. FDA announced a plan to investigate and potentially regulate caffeine.” [James Hamblin, The Atlantic; Baylen Linnekin, Reason]
FDA declines to approve new tobacco products
Is this what Congress intended, or what the public was told, when the FDA was given authority over tobacco in 2009? Jacob Grier at the Atlantic:
As first reported by Michael Felberbaum of the Associated Press, since 2009 the agency has received about 3,500 substantial equivalence reports [i.e., submissions seeking approval for new products on the grounds that they are substantially equivalent to products already on the market]. Approximately 115 employees work on reviewing them. And to date they have issued exactly zero rulings.
Can it really be the case that none of the 3,500 reflect new products that are substantially equivalent to (or for that matter safer than) the cigarettes already on the market? And while we’re asking questions, who benefits when new competition for existing products is cut off? More: Michael Siegel.
Food and farm roundup
- In Washington, DC today? Come to Cato New Media lunch where I’ll be on a panel on the nanny state;
- Future of food freedom looking brighter these days at state level [Baylen Linnekin] Polls looking good for it, too [same] “The FDA’s Pathetic Food Safety Proposal” [same]
- “Class claim against Crock-Pot seems a crock” [Sean Wajert]
- USDA issues proposed rules on vending machine fare and other school “competitive foods” [Lunch Tray, SmarterTimes, Julie Gunlock/IWF (good news: rules don’t address bake sales and birthday cupcakes. Bad news: why is this Washington’s business at all?)]
- Lawyer suing Subway over “Footlong” also handled controversial red-light camera action [NJLRA]
- So, lung, it’s been good to know you: fans of authentic Scottish haggis still vexed by US ban [BBC]
- “New Year, New Hot Coffee Case” [Abnormal Use]
New produce safety regs, and the cost to small farmers
“The FDA has issued two proposed rules to implement the Food Safety Modernization Act enacted in 2011.” [Brian Wolfman, Public Citizen, with details and links; The Packer] “The costs to fruit and vegetable growers for complying with the newly proposed produce safety regulation have been estimated at more than $30,000 annually for large farms and about $13,000 per year for smaller farms.” [The Grower] How much do typical US farm households make in a year, you may wonder? According to U.S. government figures (here and here, for example) a large proportion of smaller family farms make little or no profit, and are instead supported by the off-farm earnings of family members. The 2011 law does provide exemptions for some of the very smallest producers, and the FDA also contemplates delayed implementation of rules for some others.
We followed the issue of small farms/foodmakers and the cost of the new law here, here, here, here, here, here (amendments aimed at lessening some burdens on small producers), and on a predecessor bill, here, here, and here.
Medical roundup
- “Blaming doctors for prescription drug abuse” [White Coat] Judge rules victim of pharmacy robbery can proceed with suit against doctor who prescribed painkillers [NYLJ]
- Louisiana Gov. Jindal’s proposal for letting contraceptives be sold over counter has good libertarian pedigree [David Henderson, Jonathan Adler] More: Ramesh Ponnuru.
- FDA vs. antiemetics: “How Long Before Zofran Gets Black Boxed?” [White Coat]
- ObamaCare vulnerable to an Origination Clause challenge? [Sandefur vs. Taranto, via Randy Barnett]
- “When a child drinks cologne, by all means, sue the doctor… ” [NJLRA]
- U.S. v. Caronia: does First Amendment protect promotion of off-label drug use? [Richard Epstein/Hoover, PoL, WSJ Law Blog, D&DL, Shackford]
- Ideas from John Goodman on med-mal reform [Psychology Today]
Medical and pharmaceutical roundup
- Community college restructures staff to avoid ObamaCare employee mandate [Daniel Luzer, Washington Monthly] New pressure toward part-time employment is a big story [Coyote] But do regulations allow shift to part-time workers as a way of evading 50-employee rule, as seemingly contemplated in above post? [Gunn Chamberlain, P.A.] Why some workers might prefer being dropped from their employer’s health plan if higher pay results [Thom Lambert]
- Eleventh Circuit: hospital can be sued for not providing sign-language interpreter for emergency department visitors [Disabilities Law/Bagenstos]
- Proposition: “Off-label use can be, in many circumstances, the standard of care.” [Drug and Device Law] On Ben Goldacre’s new book “Bad Pharma” [Tyler Cowen]
- Overnight solution to med-mal crisis? Perhaps standard for lawyers’ malpractice should automatically fluctuate to reflect that for doctors [Ted Frank, Point of Law]
- Criminalizing the professions [White Coat]
- Drug shortages persist [ACSH, earlier here, here, etc.] What the FDA could do to speed antibiotic approval [Yevgeniy Feyman, Medical Progress Today, earlier]
- Clearer line-drawing between pharmacy and mass drug-compounding needed after tainted-steroid debacle [Scott Gottlieb/Sheldon Bradshaw, WSJ, earlier] With compounding pharmacy doubtfully able to pay claims, “You’re going to get people suing everyone.” [Boston Globe, David Oliver]
Pharmaceutical roundup
- False medical reports lead to echo-mill conviction [Drug and Device Law]
- Leads for sale in mass tort cases: Actos $450, Yaz $400, Yazmin $400, Ocella $425 [Ron Miller]
- Ninth Circuit: securities suit vs. pharmaceutical company can’t piggyback on allegations of flawed clinical trials [The Recorder]
- Dubious management idea: subordinate policy/legislative advocacy to corporate social responsibility (CSR) department [Susan Crowley/PharmExec]
- “Former Glaxo VP: ‘The Criminalization of the Practice of Law Is Here’” [WSJ interview with Lauren Stevens]
- Given the state’s legal climate, does it really make sense for a big pharmco to retain its headquarters in Pennsylvania? [Ted Frank] Sounds rather appetizing actually: defendant J&J said to have run into Louisiana home cooking [Eric Alexander, D&D Law]
- On the life-threatening shortages of sterile injectables [earlier here, etc.] here’s the official line of Margaret Hamburg’s FDA, as dutifully transcribed by the Times: if “nearly a third of the industry’s manufacturing capacity is off line because of quality issues,” it’s because that capacity had been operating in an recklessly unsafe manner, and it in no way reflects on the FDA’s stringent new GMP regulations on manufacturing processes, with which drug makers could easily comply were they not so inured to putting up with weevils, rust and urine on the production line. Note however this significant bit: “The shutdowns have contributed to a shortage of critical drugs, and [loosely state-regulated] compounding pharmacies have stepped into the gap as medical professionals scramble for alternative sources. But several serious health scares have been traced to compounding pharmacies in recent years,” including a deadly new meningitis outbreak. [Katie Thomas, NYT]