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FDA

At Reason, Baylen Linnekin asks me and several other people what key story we’re watching in the world of food policy. My answer:

The big, ominous, and still underpublicized story this year has been the Food and Drug Administration’s development of regulations to implement Congress’ panic-driven, ill-thought-out Food Safety Modernization Act of 2010. “Local growers are discovering that proposed FDA regulations would curtail many common techniques, such as using house-made fertilizers and irrigating from creeks,” reported the L.A. Times in February. Another batch of new rules will curtail the age-old practice of feeding livestock on spent beer grains, to the dismay of many small brewers and farmers. … Too bad for small, local, distinctive, traditional variety in food and farming….

Read the whole thing — including my semi-defense of the FDA on the legalities of the matter — here.

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Medical roundup

by Walter Olson on March 31, 2014

  • Latest don’t-blame-the-regulators shortage of a generic medical supply is nitroglycerin for acute cardiac care [New York Times, ACSH]
  • “Does Medical Malpractice Law Improve Health Care Quality?” Maybe not so much [Michael Frakes and Anupam Jena, SSRN via Tyler Cowen]
  • “Affordable Care Act opening doors to IT security attacks” [Ponemon via Fierce CIO] “States Barred from Requiring Obamacare Navigators Carry Error and Omission Insurance” [Craig Gottwals, Benefit Revolution] On suspension of statutory dates, Rule of Law has scanty constituency [Ramesh Ponnuru]
  • “Video Debate: Richard Epstein and Ryan Abbott on FDA, Off-Label Drug Use” [Bill of Health]
  • “Trial lawyers helped FDA with rule opening generic drug firms to lawsuits” [Paul Bedard, Washington Examiner]
  • Everyone including the agency itself discontented with FDA’s handling of new sunscreen ingredients [WaPo via Alex Tabarrok]
  • Does writing up a more careful patient chart help keep a doctor from getting sued? [White Coat]

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So long, small-and-sustainable: critics say new Food and Drug Administration regulations implementing the Food Safety Modernization Act could render uneconomic the immemorial practice of using spent beer grains to feed livestock. Both farmers and brewers are upset. [Bangor Daily News/Lewiston, Me., Sun-Journal; proposed rule]

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Medical roundup

by Walter Olson on March 14, 2014

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Nanny state roundup

by Walter Olson on February 12, 2014

  • Sock puppets: U.K. and E.U. governments both fund public advocacy campaigns on paternalism themes, effectively lobbying themselves at taxpayer expense. Sounds kinda familiar [Christopher Snowdon on Institute for Economic Affairs studies]
  • Federal government, in the form of the CDC, wishes your doctor would nag you more about your drinking [Jacob Sullum, more]
  • “$10m look into games and gun violence a bust” [Rob Beschizza; Mike Rose, Gamasutra; related, Scott Shackford]
  • Assumption of risk won a round at the California Supreme Court a year ago in a case on amusement park bumper cars [S.F. Chronicle, ABA Journal, related on Disneyland teacups] J.D. Tuccille on motorcycle risks [Reason]
  • As a country Australia is known for freedom, so why’s it a leader in enacting bans? [Vivienne Crompton, IPA "Freedom Watch"]
  • “Maine’s unwise and unconstitutional ban on disclosing the alcohol content of beers” [Jonathan Adler]
  • FDA mandate on removal of nicotine could benefit head regulator’s former client [Jacob Grier] Glaxo SmithKline, Johnson & Johnson also push bans on e-cigarettes, which compete with their nicotine therapies [Tim Carney] AGs from 24 states (AL, AZ, CA, CO, CT, DE, HI, ID, IL, IN, IA, ME, MD, MS, MT, NH, NM, NY, OH, OR, PA, RI, VT, WA) write FDA urging ban on menthol in cigarettes [CSPNet] “Cigarette Sin-Tax Hike Could Boost Black Markets” [Steven Greenhut] Brendan O’Neill on secondhand smoke [Reason]

Medical roundup

by Walter Olson on February 10, 2014

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Food roundup

by Walter Olson on December 31, 2013

  • Gee, thanks, NIH: “Taxpayer-Funded Propaganda to Show the ‘Evils’ of Private Alcohol Sales” [Michelle Minton, CEI]
  • “So this summer, under the supervision of officials from U.S. Customs, all three thousand two hundred and ninety-seven pounds of Mimolette were tossed into dumpsters and doused in bleach.” [The New Yorker, Dec. 9, subscription; S.F. Chronicle, earlier on French cheese controversy here, here, etc.]
  • FDA forced to back off FSMA regs, NYC soda ban loses twice in court, and other highlights of the year in food freedom [Baylen Linnekin] “Americans Think They Should Be Allowed to Buy Foods with Trans Fats and Caffeinated Energy Drinks” [Emily Ekins on new Reason-RUPE poll] “The Dangers of a Soda Tax” [Trevor Burrus] Linnekin podcast on FDA’s trans-fat ban [Cato, Caleb Brown interview]
  • “Annals of Closing Statements in Exploding Bottle Cases” [Kyle Graham]
  • “Minnesota says raw milk makes more people sick than recognized” [L.A. Times]
  • It’s for the children: proposals for regulating in-store food marketing [Jennifer Pomeranz via Public Citizen]
  • Federal sugar program devastated domestic candy manufacturing, as WaPo (sometimes) recognizes [Chris Edwards]

Mike Rappaport withholds his applause about that [Law and Liberty] More: Glenn Lammi, WLF.

Last week the Washington Post flayed doctors who participate in the Medicare program, along with the pharmaceutical company Genentech, because they often prescribe the $2,000-a-dose (and fully FDA-approved) eye drug Lucentis in preference to Avastin, a biologically related compound also made by Genentech that seems to work equally well against “wet” age-related macular degeneration and can be obtained off-label from compounders for only $50 an injection (albeit with some additional risks and hassles). Taxpayers have shelled out billions of dollars, the Post complains with some justice, because many docs (currently close to half) choose FDA-approved in preference to off-label treatments.

Great investigation, guys. Now that you’ve accused doctors of being socially irresponsible and greedy for not going off-label to prescribe, could you investigate who exactly has been demonizing off-label prescribing as a dangerous, unregulated practice that the FDA needs to crack down on? What would happen if you found that that it was some of the Post’s own favorite sources and advocacy groups?

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Medical roundup

by Walter Olson on December 16, 2013

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That was quick

by Walter Olson on December 5, 2013

Class action lawyers hop on 23andMe with a lawsuit piggybacking on the FDA’s enforcement action [Nita Farahany; Ron Bailey, Reason]. Earlier here.

Related: “regulators remain serenely unconcerned about their hubris, convinced they know better than the rest of us what is good for us.” [Nita Ghei, Washington Times, and thanks for link]

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Medical roundup

by Walter Olson on November 27, 2013

  • “In a nationally representative sample, higher patient satisfaction was associated with…increased mortality.” [White Coat/BirdStrike]
  • Low premiums! Few glitches! Larger states “working faithfully to implement the law with as few glitches as possible”! New Yorker’s Oct. 7 “Talk of the Town” on ACA’s smooth launch is a retrospective hoot;
  • Massachusetts Nurses Association goes all Venezuelan on hospital governance [Ira Stoll]
  • “Can a healthcare provider make an arbitration agreement with patients for resolving future malpractice disputes?” [Alex Stein]
  • “FDA Proposal To Curb Painkiller Overdose Deaths Would Add Burdens For Pain Patients” [Radley Balko]
  • Georgia DUI expert in hot water [PennLive] “Deconstructing the mechanical engineer” [Manhattan; Eric Turkewitz]
  • “FDA Suspension of Ponatinib: Serious Problem, Wrong Solution” [Richard Epstein, leukemia drug]
  • “Missouri Lawmakers Override Veto to Enact Good Samaritan Law” [Michael Cannon, Cato]

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There are so many reasons to resist the FDA on this action — really, as many reasons as there are individual 23andme users. Some of us want to seek out distant relatives and clues about national origins, or satisfy curiosity about patterns of disease in our family lines. For adoptive families, home genome testing can be hugely valuable in cases where one knows little about the medical history of an adoptee’s birthfamily. It’s our body, and our right to inform ourselves about it — or so we thought.

Some are blaming the company for rolling out the popular service in the absence of a clear regulatory go-ahead, and, in recent months, ignoring repeated signals of the FDA’s wish that it submit to comprehensive regulation that would greatly drive up the cost of its service. But other commentators have suggested that the firm has some pretty decent legal arguments that its service is not subject to regulation as a diagnostic test or “medical device” (genetic predispositions are not diagnoses). As an information-based service, it might even enjoy protection under the First Amendment. Admittedly, the company waved a red flag in front of regulators when it launched a marketing campaign that stressed the possible health benefits of knowing one’s genetic predispositions. But as Timothy Lee argues at the Washington Post:

Having more information about your health status is never dangerous by itself. It only becomes dangerous if patients use it to make dangerous medical decisions. But most dangerous medical decisions can’t be made unilaterally; they generally require the assistance of licensed medical professionals who will do their own assessment of the situation before performing procedures that could harm patients.

The FDA very likely has decent legal grounds to forbear from a crackdown should it choose to. But the key takeaway sentence from Matthew Herper’s piece in Forbes criticizing the company is: “This is not the way to deal with a powerful government regulator.” Disrespectful, anti-authority attitudes from someone an agency intends to regulate? Ask former Buckyballs CEO Craig Zucker where that gets you.

What can users, potential users, and well-wishers do?

* “First, download your 23andMe raw results now if you have them,” warns Razib Khan at Gene Expression.

* If you like signing Change.org petitions, there’s one here asking the FDA to back off.

* In a separate piece for Slate, Khan suggests where the situation might head before long: services like this can move offshore. All the relevant information consumers want from them can be delivered via the web. In the mean time a highly innovative and valuable enterprise will have been pushed out of the U.S. to some freer part of the globe, but maybe we need to get used to that happening.

And then? It may take a while before our government works up the nerve to ban mailing a saliva sample to a foreign address. Based on existing trends, I’d guess the more likely intervention, circa 2018 or so, would be for the Treasury to direct credit card companies not to process payments from U.S. residents to genome kit providers. Would we have the spirit to resist then? And if then, why not now? More: Alex Tabarrok, Slate Star Codex (by analogy, “banning people from weighing themselves without a prescription is neither clinically nor ethically sound,” although weight awareness sometimes leads patients into unwise health decisions), Nita Farahany, Brad Warbiany, earlier 2011. Alex Tabarrok’s post is especially worth reading, an excerpt:

…Indeed, genetic tests are already regulated. To be precise, the labs that perform genetic tests are regulated by the Clinical Laboratory Improvement Amendments (CLIA) as overseen by the CMS (here is an excellent primer). The CLIA requires all labs, including the labs used by 23andMe, to be inspected for quality control, record keeping and the qualifications of their personnel. The goal is to ensure that the tests are accurate, reliable, timely, confidential and not risky to patients. …

…the FDA wants to judge not the analytic validity of the tests, whether the tests accurately read the genetic code as the firms promise (already regulated under the CLIA) but the clinical validity, whether particular identified alleles are causal for conditions or disease. The latter requirement is the death-knell for the products because of the expense and time it takes to prove specific genes are causal for diseases….

The FDA also has the relationship between testing and clinical validity ass-backward. The FDA wants to say no to testing until clinical validity is established but we are never going to discover clinical validity until we have mass testing.

More: Richard Epstein/Point of Law, BoingBoing, more from Ron Bailey.

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Food roundup

by Walter Olson on November 26, 2013

BlueBandMargarineAd

  • “The FDA’s Ill-Conceived Proposal to Ban Trans Fats” [Baylen Linnekin] Margarine and other butterfat substitutes help in keeping a meal kosher, but FDA appears indifferent to individual preference [Ira Stoll] Can the baker fudge the formula for Baltimore’s Berger cookies? [Baltimore Sun, WTOP/Capital] Organized grocery lobby appears to be going quietly, perhaps a misguided strategy since this sets a precedent for yanking familiar ingredients off Generally Recognized As Safe (GRAS) list, and many activists would like to move on to things like sugar next [Bloomberg Business Week, Doug Mataconis/Outside the Beltway, Michelle Minton/CEI, Bainbridge] Switch to palm oil might accelerate deforestation [Scientific American]
  • FDA’s regs implementing Food Safety Modernization Act could tank small farmers and other food operations, commenters write in by thousands [Baylen Linnekin, Jim Slama, HuffPo]
  • Proposed Austin curbs on fast food restaurants might ensnare its beloved food trucks [Linnekin]
  • Any day now FDA could issue long-awaited, highly burdensome new menu calorie labeling regs [Hinkle] Sens. Roy Blunt (R-MO) and Angus King (Ind.-ME) introduce bill to excuse grocers and convenience stories from rules and simplify compliance for pizzerias [Andrew Ramonas/BLT]
  • “Panel weighs in on soda ban at law school” [NYU News covers my recent panel discussion there with Jacob Sullum and Prof. Roderick Hills, pic courtesy @vincentchauvet]
  • “Organic Farmers Bash FDA Restrictions On Manure Use” [NPR via Ira Stoll]
  • Nick Farr looks at NYT retrospective on the Stella Liebeck (McDonald’s) hot coffee case [Abnormal Use]
  • “Sugar is the most destructive force in the universe” according to expert witness who meets with less than favorable reception in corn syrup case [Glenn Lammi, WLF]

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Emergency meningitis vaccine

by Walter Olson on November 19, 2013

“It’s good that the FDA lifted the ban on Bexsero but why should Americans have to wait for the FDA?” [Alex Tabarrok, Bloomberg]

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Medical roundup

by Walter Olson on November 13, 2013

  • Pressure from HHS leads day cares to ban practice of baby-swaddling, and not everyone’s pleased about that [Abby Schachter, Reason]
  • “If Big Pharma likes your healthcare plan, you can keep it” [Tim Carney]
  • For “those of us with polycystic kidney disease… stringent FDA regulation seems to be taking away hope” [Bill Brazell, Atlantic] And: speaking of the FDA, “Dallas Buyers Club Is a Terrific Libertarian Movie” [David Boaz, Cato] Also: New Peter Huber book, “The Cure in the Code: How 20th Century Law Is Undermining 21st Century Medicine” [Basic/Manhattan Institute, Wired]
  • $7,440 annual expected loss per hospital bed in Florida vs. $810 in Minnesota, and other med-mal loss statistics [Becker's Hospital Review via TortsProf]
  • Charge: black lung defense firm finds ways to conceal medical expert reports from adversaries [Center for Public Integrity via Joe Patrice, Above the Law]
  • Prescribing drugs for off-label uses is perfectly legal, but Johnson & Johnson will pay $2.2 billion for promoting the practice [Ann Althouse]
  • Jury awards $4 million legal malpractice verdict against prominent D.C.-based plaintiff’s firm [Richmond Times-Dispatch via White Coat]
  • “Can You Secretly Record the Medical-Legal Exam?” [Eric Turkewitz]

KeepYourLaws“The Food and Drug Administration announced Thursday it is taking the first step toward banning dangerous trans fats that are found in a variety of processed foods. The agency said in a statement that the fats, used in a number of products from margarine and coffee creamer to frozen pizza, are a major health concern for Americans despite lower consumption of the dangerous, artery-clogging fats over the last twenty years.” [Chicago Tribune, our earlier coverage] More: Julie Gunlock, IWF; Scott Shackford, Reason; Michelle Minton, CEI (logic of removing ingredient from GRAS list based on long-term cumulative health effects could point toward regulating salt, sugar).

From comments: “Trans fats are pretty rare in my experience at this point outside of, ironically, military rations.” [L.C. Burgundy] More: Via Jacob Grier, Olga Khazan at The Atlantic recalls the days when the Center for Science in the Public Interest (CSPI) denounced restaurant chains for using saturated fat. The ensuing pressure campaign resulted in a widespread switchover to supposedly healthier trans-fat.

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Medical roundup

by Walter Olson on August 22, 2013

  • No, ma’am, I’m not going to diagnose your kids with PTSD after your low-speed auto accident, but I’m sure some other doc will [White Coat]
  • In time to avert catastrophe? “FDA reboot of antibiotic development” [David Shlaes] Role of price controls in shortages of sterile injectables [ACSH]
  • Trial lawyers launch campaign to roll back MICRA, law that has limited California med-mal payouts [KPBS, L.A. Times]
  • DNA panopticon beckons: “Mississippi law requires cord blood from some teen moms” [Emily Wagster Pettus, AP, earlier]
  • Dear N.Y. Times: please make up your mind whether it’s OK to break health privacy laws [SmarterTimes]
  • Committee of AMA decides on schedules by which doctors are paid. And you were expecting it to be done how? [Arnold Kling]
  • “The more your doctor worries about getting sued, the more you’ll end up spending on medical tests” [MarketWatch on Michelle Mello study in Health Affairs] Oklahoma high court used strained rationale to strike down certificate of merit law [Bill of Health]

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