Posts Tagged ‘FDA’

FSMA, foodies and the state of chow law

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.

Filed under: agriculture and farming, FDA, FSMA

Medical roundup

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]

Filed under: FDA, medical malpractice, ObamaCare

FDA rules could block use of brewers’ wastes as animal feed

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] More: Glenn Lammi, WLF.

Filed under: agriculture and farming, beer and brewers, FDA, FSMA

Medical roundup

Oscar-winning “Dallas Buyers Club” should please libertarians and FDA reformers [David Boaz/Cato, Jack Hunter/Rare, Kyle Smith/Forbes]
Don’t assume patent trolls won’t threaten pharma/biotech [Nicholson Price, Bill of Health]
“Why are patients shut out of the debate over prescription pain medicine?” [Maia Szalawitz]
A retrospective on the Satanic abuse panic [Richard Noll, courtesy Maggie McNeill] And why you haven’t read it at Psychiatric Times [Gary Greenberg]
High-profile medical and custody dispute in Massachusetts over teenager Justina Pelletier appears to pit hospital against hospital [Boston Globe (autoplays), CBS Boston, J.D. Tuccille/Reason]
Actual fertility procedure under FDA consideration doesn’t live up to hype about supposed “three-parent babies” [Nita Farahany]
Study points to benefits of easing licensing constraints on nurse practitioners [Jeffrey Miron, Cato]
More: Florida Supreme Court, long elected with support from plaintiff’s bar, invalidates medical malpractice limits [Miami Herald, Alex Stein/Bill of Health]

Filed under: child abuse, FDA, Florida, medical malpractice, movies film and videos, occupational licensure, patent trolls, pharmaceuticals

Nanny state roundup

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]

Filed under: advocacy funding, alcohol, amusement parks, assumption of risk, Australia, beer and brewers, FDA, Maine, nanny state, tobacco, videogames

Medical roundup

Trial lawyer push to weaken MICRA, the medical damages cap, could spark most expensive ballot measure struggle in California history [Legal NewsLine]
Why the FDA should lay off 23andMe [Robert Green and Nita Farahany, Nature via Volokh, earlier]
SEIU to West Coast hospitals: play ball with our organizers or we’ll arrange to cap your execs’ pay [Bloomberg]
Video of panel discussion on new book A Conspiracy Against ObamaCare [Randy Barnett et al., more]
Louisiana high court throws out $330 million award to state, federal governments over marketing of Risperdal [NOLA.com/Times-Picayune, Eric Alexander/Drug and Device Law]
“If Obamacare Doesn’t Kill Small Medical Practices, Bureaucratic ICD-10 Coding Requirements Might” [Tuccille]
FDA goes after antibacterial soap. Wisely? [White Coat]

Filed under: California, FDA, hospitals, Louisiana, medical, medical malpractice, ObamaCare, pharmaceuticals

Food roundup

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]

Filed under: advertising, advocacy funding, alcohol, FDA, food safety, soft drinks, trans-fats

FDA stands guard against approval of Meningitis B vaccine

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

Filed under: FDA, vaccines

The Washington Post on Medicare eye drugs

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?

Filed under: FDA, Medicare, pharmaceuticals

Medical roundup

“Essentially, the agency wants to ‘protect’ patients from knowing about their own health” [David Rivkin and Andrew Grossman, USA Today, earlier] FDA-defying workaround lets you get your info even if 23andme’s muzzled [Ron Bailey]
“Insane Department of HHS plan would criminalize lifesaving bone-marrow donor incentives out of woolly concern with ‘altruism'” [Steven Pinker, Sally Satel/Bloomberg, Michelle Meyer/Bill of Health]
Affordable Care Act opens up funding stream for alternative medicine. The start of something big? [Kevin Williamson, NRO]
On underused Gotham hospitals, de Blasio is in hole of his own digging [Bob McManus, City Journal]
ADA lawsuit against hospital a harbinger of others to come? [Peoria Journal-Star]
If goal is access to affordable contraception, making Pill available over the counter would seem good first step [Shikha Dalmia/Time, earlier]
Home-health-aide overtime rules are bad news for seniors hoping to stay out of nursing homes, but AARP can’t shake its scripted role as loyal union ally [More: Free Beacon, from 2011 on AARP brief in state overtime case; earlier here, here, and here]

Filed under: FDA, hospitals, NYC, ObamaCare, pharmaceuticals