Posts Tagged ‘FDA’

Experimental drugs, terminal patients, and “right to try” statutes

Many libertarians have expressed interest in statutes, enacted in five states, which seek to give incurably ill patients access to “investigational” drugs which have passed the first stage in the FDA’s approval process but not reached final approval. Nice goal, but according to James Beck at Drug & Device Law:

…we don’t think these statutes are going to accomplish much, let alone achieve their purpose of making investigational drugs generally available to terminally ill patients having no other choices.

One obstacle is the supremacy of the FDA:

States can pass all the laws they want, but unless the FDA gives its okay to programs more expansive than its compassionate use (“expanded access”) program, nothing’s going to happen. It’s called “preemption.”

A second is liability. While the new crop of statutes are an improvement on earlier proposals which sought to conscript pharmaceutical companies’ participation, they still give drugmakers no strong protection from resulting lawsuits, and sometimes include language hinting at the reverse. Even though plaintiff’s lawyers would face their own challenges of proving causation and damages, there would still be unknowable legal downside with relatively scant upside, making for poor incentives to participate in the program by making investigational drugs available.

Filed under: FDA, pharmaceuticals

Food roundup

Sugar, tea, fish and game, public houses: food freedom grievances helped fuel America’s revolution against Britain [Baylen Linnekin]
Colorado, Oregon voters consider GMO labeling, which “likely will mislead more than inform.” [David Orentlicher, Health Law Prof and more] “Say No to GMO Labeling, Even If It Feels Terrible” [alt-weekly Portland Mercury; earlier on GMOs]
“White House Boosts Fictional ‘Food Addiction’ Concept to School Kids” [Glenn Lammi, WLF]
D.C. Circuit: immigration law doesn’t block specialized Brazilian steakhouse chefs from coming to U.S. [Joe Palazzolo, WSJ Law Blog]
“Why Is the USDA Buying Submachine Guns?” [Modern Farmer]
Little evidence new FDA food labeling rules will improve health [Robert Scharff and Sherzod Abdukadirov/Regulation mag, more] Flaws of agency’s “added sugar” labeling proposal [Glenn Lammi, WLF]
California tries to dictate standards for raising animals in other states; do you think the Constitution might have something to say about that? [Linnekin]

Filed under: agriculture and farming, California, constitutional law, eat drink and be merry, FDA, immigration law, obesity

Food roundup

Our posts on the closure of California’s Westover Winery following punitive fines for letting customers volunteer continue to draw interesting comments, including one from a reader identifying himself as William Smyth, owner of the winery;
FDA comes out with revised proposed FSMA rules, a preliminary look [AP] Agency only partially backs off restrictions on use of spent brewing grains as animal feed [Elizabeth Brown/Reason, WLF, earlier]
“Cottage food” law success: “Texans Created Over A Thousand Local Businesses After Texas Eased Restrictions On Selling Food” [Nick Sibilla, IJ/Forbes]
Artisanal salami maker eventually managed to persuade FDA that it should be permitted to ferment product at 72 degrees as the Italians do [WaPo] Craft sausage startup in Detroit “sort of operated under ‘do-things-until-you-get-caught” [Metro Times]
Does drinking diet soda make you fat? [Daniel Engber, Slate]
Kalona, Iowa maker of squeaky cheese curds cites mounting regulatory costs in decision to close (via Julie Gunlock) [Cedar Rapids Gazette]
Bee colonies getting sick: indictment of modern humanity’s interaction with nature? [Timothy Taylor, Conversable Economist]

Filed under: agriculture and farming, eat drink and be merry, FDA, food safety, FSMA, soft drinks

Medical roundup

Down comes the pediatrician’s wall of baby pictures, another HIPAA casualty [Anemona Hartocollis/NY Times, resulting letters to the editor, earlier, NPR with somewhat different slant]
Had the Washington Post stayed on story of Maryland health exchange fiasco, it might have held power to account [my Free State Notes]
FDA rules requiring that certain drugs be kept out of hands of anyone but patients may inadvertently establish monopoly for some off-patent compounds [Derek Lowe via Alex Tabarrok]
Richard Epstein argues Hobby Lobby right result, wrong reasoning [new Cato Supreme Court Review, more]
Defensive medicine: so much easier to go ahead and order the ultrasound [White Coat]
Fate of melanoma-scanning device and the FDA [Alex Tabarrok via Elizabeth Nolan Brown] Can agency learn from European private certification? [more]
Seredipitous offshoot of study on rats helped premature infants; but would this have been quite as likely to appear in HuffPo if framed as “what we owe lab-animal research” rather than “what we owe federal research”? [Sam Stein; related, first volunteer given new trial Ebola vaccine, and a hat tip to lab-animal research on that too [Wellcome, U.K.]

Filed under: animal rights, defensive medicine, FDA, HIPAA, Maryland

“FDA restrictions keeping some great cheeses out of stores”

It’s happening just as warned. Janet Fletcher at the Los Angeles Times:

…cheese counters could soon be a lot less aromatic, with several popular cheeses falling victim to a more zealous U.S. Food and Drug Administration. Roquefort — France’s top-selling blue — is in the agency’s cross hairs along with raw-milk versions of Morbier, St. Nectaire and Tomme de Savoie. …

Of course, French creameries haven’t changed their recipes for any of these classic cheeses. But their wheels are flunking now because the FDA has drastically cut allowances for a typically harmless bacterium by a factor of 10.

The new rules have resulted in holds even on super-safe Parmigiano Reggiano, and the risk of losing a costly shipment of a perishable commodity is likely to be enough to drive many European producers out of the market for export to America entirely. Highly praised artisanal cheese makers in the United States are facing shutdown as well. [Michael Gebert, Chicago Reader] Earlier on the FDA and cheese regulation here and, from Cato, here (2010 predictions, before FSMA passed), here, here, etc.

They told us this administration was going to be run by wine and cheese faculty liberals. Now where are they when they could actually do us some good?

Related, note that the regulatory pressure is coming from both sides of the Atlantic: “Newsweek: French cheesemakers crippled by EU health measures” [Cheese Notes, with discussion of role of giant manufacturers whose processed cheese operations can comply with the rules] (& welcome The Week, Reason readers; cross-posted at Cato at Liberty)

Filed under: Europe, FDA, food safety, France, free trade, FSMA

Food roundup

“New York Times Hosts Panel on Farming, Forgets to Invite Farmers” [Julie Gunlock, IWF]
Historical perspectives on the current attack on food freedom [Baylen Linnekin and Michael Bachmann for the Institute for Justice; report, PDF, and summary; Reason and more Linnekin on the FDA’s odd campaign against added ingredients which also occur naturally]
Food Safety Modernization Act of 2011 will increase costs and reduce variety in food intended for animals as well as for humans [Jerry Ellig and Richard Williams, Cato Regulation]
Elyria pink cookie, pride of the Ohio town’s school system, is casualty of federal food rules [Chronicle-Telegram, WEWS] NYC may launch another attack on toys in McDonald’s Happy Meals [Jeff Quinton, earlier]
UC Berkeley project assists effort to step up labor union presence in food area [Bill McMorris on Food Labor Research Center]
Lungs are better in the open air: Scotland has at least one haggis food truck [Baylen Linnekin, Vice mag]
“Eat great on food stamp budget” cookbook is hit, even if fans may not always have thought through its political valence [Maryn McKenna, National Geographic “The Plate”] Push to make food stamp program data public [Slate, USDA comments]

Filed under: agriculture and farming, eat drink and be merry, FDA, food safety, FSMA, McDonald's

Salt: better regulate fast before the panic subsides?

Even as the FDA prepares ambitious new rules pressuring food makers to reduce the amount of salt in their wares — recipe regulation, as we’ve called it — a new study questions whether most people in Western countries really need to cut salt after all. The study, led by Dr. Salim Yusuf of McMaster University, finds evidence consistent with sodium being a health risk for person with hypertension and those with the highest salt intake, but also suggests that most of the population is in the optimal zone for salt intake and that adding potassium-rich fruits and vegetables to the diet may be a superior way for many to fend off bad effects from sodium. The study ran jointly in the New England Journal of Medicine with a second which lays more emphasis on hazards of salt intake. [Yahoo News] More: Just One Minute, ACSH.

Filed under: FDA, salt

FDA vs. wooden onion crates

We’ve warned many times that the Food Safety Modernization Act of 2011 is sure to drive up food prices, make life hard for small farmers, and encourage the substitution of industrial farm methods for the traditional and local. Now the FDA is rumbling that wooden onion crates may need to give way to plastic, although defenders say wooden crates have a good safety record in actual use. “Replacing a million wooden crates would cost about $200 million. … plastic crates can only hold about half the weight of wooden ones and they cost nearly three times as much.” [Economics 21]

In June, after an outcry, the FDA backed off hints that it would end the age-old practice of aging cheese on wooden boards.

P.S. Interesting discussion in comments on whether the cited cost figures are plausible. One thing I like about Overlawyered readers is that they know so much about onion crates.

Filed under: FDA, FSMA

Medical roundup

Doctor criticized on Science-Based Medicine blog proceeds to sue [Steve Novella, Orac]
“Can you imagine Google becoming a health company?” Sergey Brin: doubt it, field’s “just so heavily regulated” [Michael Cannon/Cato, David Shaywitz]
“One Box of Sudafed Over the Line: Florida Woman Arrested for Trying to Relieve Allergy Symptoms” [Jacob Sullum]
MICRA battle: survey finds OB-GYNs in Los Angeles County pay average $49,804 a year for coverage, in Long Island where there’s unlimited liability it’s $196,111 [Legal NewsLine]
Medical liability claims fall in Wisconsin [Althouse] And Pennsylvania [TortsProf]
FDA wants to look over drugmakers’ shoulders when they communicate with consumers, not an easy formula for social media [Elizabeth Nolan Brown]
“The reason that we are being required to measure BMI isn’t because a patient’s BMI has any meaningful clinical use … it’s that the BMI can be measured.” [White Coat]

Filed under: FDA, Google, medical malpractice insurance, MICRA, pharmaceuticals

Food roundup

Obama pick for USDA nutrition chief advances food-as-social-justice theme [Politico, Free Beacon and more, Jeff Stier/Des Moines Register]
Hawaii GMO battle is one the whole nation should watch [Mark Strauss, io9]
“Overprotective Government, Overweight Kids?” [Lenore Skenazy]
“Cherry wars: The crazy economics of Michigan’s favorite pitted fruit” [Bridge Magazine]
“FDA’s Artificial Trans Fat ‘Ban’: A Dangerous Step to Control Personal Dietary Choices” [Daren Bakst, Heritage via Michelle Minton, CEI]
And in the wings: FDA readies crackdown on salt as ingredient [AP]
French law mandating disclosure of whether restaurant food is made in house isn’t going well [Baylen Linnekin, more]

Filed under: agriculture and farming, FDA, France, Hawaii, Michigan, obesity, restaurants, salt, trans-fats