Posts Tagged ‘FDA’

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.

Food roundup

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]