Posts Tagged ‘FDA’

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]

Food and beverage roundup

FDA issues calorie label mandate

Another hidden gift inside the Affordable Care Act: mandatory calorie labeling for many restaurant menus. Walter Olson comments on the complications and potential unintended consequences of such a mandate.

My new Cato podcast: the new FDA calorie labeling rules apply to not-so-big chains (20 +) of grocery stores and amusement facilities as well as restaurants, and make it less likely that servers and local managers will manage to vary from rigidly standardized recipes, menu listings and portion sizes based on knowledge of their local customers, temporary availability of attractive ingredients, and so forth. That won’t matter much for food servers who already design their offerings in a lab, but spells trouble for those whose offerings are more localized or unpredictable (earlier). Coverage by Ed Morrissey of what the scheme would mean for a 21-unit pizza chain is linked here.

In January, David Boaz commented on the parallel vending machine calorie label mandate:

In my experience, vending machines shuffle their offerings fairly frequently. If the machine operators have to change the calorie information displayed every time they swap potato chips for corn chips, then $2,200 [per operator per year] seems like a conservative estimate of costs. But then, as Hillary Clinton said when it was suggested that her own health care plan would bankrupt small businesses, “I can’t be responsible for every undercapitalized small business in America.”

Happy Thanksgiving!

More: Baylen Linnekin. And Julie Gunlock recalls her own days working in a supermarket deli. Goodbye, making up prepared salads in single-serving containers from whatever produce happened to be in overstock at the time. Hello, food waste!

Cato online forum, “Reviving Economic Growth”

The panel is packed with big names and many of them offer suggestions with a law or regulation angle, including Philip K. Howard (“Radically Simplify Law”), Derek Khanna (rethink patent and copyright law; related, Ramesh Ponnuru), Morris Kleiner (reform occupational licensure; related, Steven Teles), Arnold Kling (“Sidestep the FCC and the FDA”), Robert Litan (admit more high-skill immigrants and reform employment of teachers; similarly on immigration, Alex Nowrasteh), Adam Thierer (emphasize “permissionless innovation”), and Peter Van Doren (relax zoning so to ease movement of workers to high-wage cities).

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.