Posts Tagged ‘FDA’

Medical roundup

  • Study of Type I, Type II error finds FDA much too conservative in drug approval [Vahid Montazerhodjat and Andrew Lo via Tabarrok]
  • Behind push to license/regulate personal trainers in Washington, DC and elsewhere: ACA opened spigot of publicly channeled wellness money [Aaron Davis/Washington Post via Tyler Cowen, Peter Suderman]
  • “Medical lending”: financiers “invest in operations to remove pelvic implants, [reap] payouts when cases settle” [Alison Frankel and Jessica Dye, Reuters]
  • War on Some Drugs again collides with cancer therapy: “Psilocybin, it appears, targets this existential and spiritual distress.” [Ann Althouse]
  • Citing First Amendment, federal court enjoins FDA from prohibiting truthful speech by drugmakers about off-label uses [WSJ, Alex Tabarrok (in recent years, federal government “has extracted billions of dollars in settlements from pharmaceutical firms for engaging in what appears to be constitutionally protected speech”), Beck and Sullivan, Drug & Device Law on Amarin v. FDA]
  • SEIU 1199: “The union that rules New York” [Daniel DiSalvo/Stephen Eide, Daily Beast and City Journal]
  • Controversial therapist who is also anti-vaccine expert witness loses court challenge to Maryland medical license revocation [Beck, Drug and Device Law]

Food roundup

  • Tufts doc who wants to “eliminate” sweetened drinks is senior author on flawed new study on their health effects [Gil Ross, ACSH]
  • Nick Gillespie interviews celebrity chef Geoffrey Zakarian (“In Praise of Free Enterprise Food”) and Whole Foods’ John Mackey. “Despite the strength of our local food movement, Kentucky joins Delaware and Rhode Island as the three most restrictive states in the country for cottage food sales.” [LEO Weekly, Louisville]
  • Fears of toast-spread homebrew in remote communities: “Australia suggests Vegemite sales limit amid ‘alcohol abuse'” [BBC] More: less-sensational followup coverage h/t reader Mark N. in comments;
  • You really ought to give Iowa-defiance a try: Rand Paul is latest candidate to oppose ethanol mandate [Rare]
  • “Next Time Government Gives You Dietary Advice, Consider Doing the Opposite” [David Harsanyi] Multiple topping combinations + steep penalties add up to vexation for pizza makers under FDA menu labeling mandate [Savannah Saunders, Economics21; Veronique de Rugy, Reason] “Health Canada Gets it Right, While FDA Goes Further Astray, on ‘Added Sugars’ Labeling” [Glenn Lammi, WLF]
  • “Federal Judge, Referencing FDA Order on Trans Fat, Permits State-Law Class Action to Proceed” [Glenn Lammi, WLF]
  • Plaintiff says he bit into someone else’s gold tooth in his biscuit [Nick Farr]

August 19 roundup

  • “Photos of Your Meal Could be Copyright Infringement in Germany” [Petapixel]
  • National Labor Relations Board opts to dodge a fight with college football [Daniel Fisher, Forbes]
  • Governor’s commission charged with recommending new redistricting system in Maryland includes possibly recognizable name [Washington Post, Southern Maryland Newspapers; thanks to Jen Fifield for nice profile at Frederick News-Post]
  • Trial bar’s assault on arbitration falls short: California Supreme Court won’t overturn auto dealers’ standard arbitration clause [Cal Biz Lit]
  • Ontario lawyer on trial after prosecutors say sting operation revealed willingness to draft false refugee application [Windsor Star, more]
  • “Vaping shops say FDA regulation could put them out of business” [L.A. Times, The Hill] Meanwhile: “e-cigarettes safer than smoking, says Public Health England” [Guardian]
  • I was honored to be a panelist last month in NYC at the 15th annual Michael R. Diehl Civil Rights Forum, sponsored by the law firm of Fried, Frank, alongside Prof. Marci Hamilton (Cardozo) and Rose Saxe (ACLU) discussing the intersection of religious accommodation and gay rights [Fried, Frank] Also related to that very current topic, the Southern California Law Review has a symposium on “Religious Accommodation in the Age of Civil Rights” [Paul Horwitz, PrawfsBlawg]

Trans fats banned! Now make way for palm and coconut oil, GMOs…

Pushed by a lawsuit, the Food and Drug Administration has followed through and banned the use of trans fats in processed food: producers have three years to phase out the substance. I’ve got a new piece at Cato making a few basic points: the move is sheer paternalism, it’s setting a precedent (against voluntary consumer assumption of even small risks) that activists are eager to roll out against other ingredients like salt and sugar, it’s not popular with the public (this poll finds a plurality, not majority, going along, while this one finds majorities opposed). And voluntary consumer adjustments (trans fat consumption is down by an estimated 85 percent) have already cut Americans’ average daily intake to half of what the American Heart Association recommends.

Then there’s the sadly ironic history of the whole subject: trans fats were avidly promoted at the time by the same sorts of public health activists and government nutritionists who now push for a ban. CNN:

Dr. Steven Nissen, the chair of cardiovascular medicine at the Cleveland Clinic, praised the FDA for its “bold courage” and said it “deserves a lot of credit” for taking this “enormously important” move.

“In many ways, trans fat is a real tragic story for the American diet,” Nissen said. “In the 1950s and ’60s, we mistakenly told Americans that butter and eggs were bad for them and pushed people to margarine, which is basically trans fat. What we’ve learned now is that saturated fat is relatively neutral — it is the trans fat that is really harmful and we had made the dietary situation worse.”

Or as my colleague Scott Lincicome puts it, “Food tyranny didn’t fail. It just needed better managers”

Now make way for the most popular, and still legal, substitutes for trans fats: tropical palm and coconut oils, each with problems of its own. And an even better prospect — the next panic? –is GMO-derived high-oleic soybean oil.

My Cato piece is here. And I made the WSJ’s Notable & Quotable today on this subject, which is always nice.

June 3 roundup

  • Ohio appeals court: code enforcement officers in town of Riverside can be personally liable for towing cars off man’s property without due process [The Newspaper; Vlcek v. Chodkowski, Second Appellate District, Montgomery County]
  • “FDA’s proposed cigar crackdown could effectively ban up to 80% of stogies currently sold in US” [James Bovard, Washington Times; earlier here, here]
  • Don’t decriminalize subway farebeating, says Nicole Gelinas, it’s a deliberate theft and a damaging one (though “enforcing the fare helps enforce New York gun laws” may not work as an argument unless you admire those gun laws) [New York Post]
  • Lawyers take Fifth and (via their attorney) blame paralegal over DUI setup of a trial opponent [ABA Journal; Adams and Diaco, Florida]
  • “The Questionable History of Regulatory Reform Since the APA” [Stuart Shapiro and Deanna Moran, Mercatus]
  • Did American rebels of 1776 fight for English liberties, or universal Rights of Man? [David Boaz, Cato, taking issue with Daniel Hannan]
  • “Appeals court scolds Apple monitor, but does not remove him” [Jeff John Roberts, Fortune; Eriq Gardner, THR; Colin Lecher, The Verge; earlier]

The petty tyranny of the FDA’s coming trans fat ban

Don’t count on donuts, frozen pizza, coffee creamers, or canned cinnamon rolls to go on tasting the same — and don’t count on the federal government to respect your choices in the matter [Peter Suderman, earlier] And of course it was public health advocates and the federal government who helped push foodmakers into the use of trans fats in the first place. Some choices do remain to you in the realm of food, so say yes to Mark Bittman’s red lentil dal, no to his politics [Julie Kelly and Jeff Stier, Forbes]

CDC’s Frieden in denial about good news on vaping

Actual cigarette smoking among teens, the kind that requires inhaling carcinogenic products of combustion, is down a startling 25 percent in one year and nearly 42 percent since 2011. The reason is the rapid substitution of vaping or e-cigarettes, which hold singular promise as a harm-reduction measure for those drawn to the nicotine habit. Great news, right? Not if you listen to Thomas Frieden of the Centers for Disease Control, who’s doing his best to disguise good tidings as bad so as to stoke the officially encouraged panic about vaping. New York Times columnist Joe Nocera nails Frieden on the issue [h/t @jackshafer], providing a model of appropriately skeptical press scrutiny of someone who hardly ever gets subjected to that. More on Frieden; David Henderson on how FDA hostility to vaping could slow the shift from more-toxic alternatives; related, Greg Gutfeld on California ads trashing e-cigs.

P.S. Andrew Stuttaford thinks Frieden’s not in denial, he knows better.

Pharmaceutical roundup

  • War on painkillers finds new casualty in ailing veterans [Washington Post, Brian Doherty]
  • “Woman says ‘Fifty Shades of Grey’ lube doesn’t deliver, should be registered with FDA” [Legal NewsLine]
  • “Robert F. Kennedy Jr.’s Twisted Anti-Vaxx History” [Russell Saunders, Daily Beast back in July]
  • Using antitrust law, New York seeks to force maker to go on producing older formulation of drug [Ilya Shapiro on Cato brief in Second Circuit] Courts have mostly rejected claims of a duty to supply grounded in obligation to patients [James Beck, Drug & Device Law]
  • “Patients see [biotech] startups and hope for a cure. Too many lawyers see them and hope for a payday.” [Standish M. Fleming, WSJ]
  • Argument that policymakers undervalue pharmaceutical aids to heroin rehabilitation [Jason Cherkis]
  • After suing the obvious defendants in New England Compounding Pharmacy contamination case, lawyers started in on the less obvious [Drug and Device Law, background on regulation-spurred rise of compounding pharmacies]