“West Virginia courts have a well-deserved reputation for favoring plaintiffs, but the state’s Supreme Court may have gone too far this year when it said drug addicts who broke the law to obtain narcotics could sue the doctors and pharmacies who supposedly fed their addiction.” Rulings like that, writes Daniel Fisher, are one reason West Virginia perennially ranks at the bottom in the U.S. Chamber’s ranking of state legal climates, and did again this year. Louisiana, Illinois, and California are other cellar-dwellers, while Alabama and Texas, despite extensive reforms and the success of business-oriented candidates in many judicial races, also languish in the lower ranks with continuing problems such as the litigation atmosphere of east Texas [Lou Ann Anderson/Watchdog Arena] More: Bob Dorigo Jones. Related, from ALEC: State Lawsuit Reform.
Financial economists and fans of old murder mysteries know about tontines. Was the law too hasty in banning them? [Jeff Guo, Washington Post “WonkBlog”]
A familiar roster of plaintiff’s firms keep grabbing profitable lead positions in mass litigations that begin with multiple filings in different states. Judges and critics suspect that committees are often overstaffed to set up a likelihood of higher fees, and that cozy mutual backscratching helps allocate lucrative positions to repeat players in the club. [Amanda Bronstad, National Law Journal]
- “In reality, government officials often have strong incentives to mandate warnings that are misleading or flat-out wrong” [Ilya Somin] George Akerlof and Robert Shiller’s analysis of consumers as fools leaves something to be desired [Alex Tabarrok, New Rambler Review]
- “The suppression of competition [is] a core driver of skyrocketing inequality.” New Steven Teles article sure to be much discussed touches on occupational entry restriction, land values inflated by municipal regulation, many other topics of interest [National Affairs]
- “Patterico Prevails: Vexatious Legal Attack on Speech Fails” [Popehat]
- On the topic of legal remedies against looks-ism, which I wrote about in The Excuse Factory, C-SPAN airs my comments as a counterpoint to Prof. Rhode [video, begins 1:30, more including transcript]
- “How copyright is killing your favorite memes” [Caitlin Dewey, Washington Post “Intersect”]
- University of Nebraska/Kearney agrees to pay $140,000 to two former students for not allowing psychological support dogs in dorms [Department of Justice press release]
- Regulation of child care provision drives up costs, has unintended consequences [Diana Thomas and Devon Gorry, Mercatus]
In light of President Obama’s (quite admirable) recent comments on college as a place for the open exchange of ideas, could his administration call off its rules pressuring colleges to adopt unconstitutional speech codes? [Hans Bader, Glenn Reynolds, USA Today] “University of California considering recognizing a ‘right’ to be ‘free from … expressions of intolerance'” [Eugene Volokh; regents go back to drawing board; Sarah McLaughlin/FIRE; AAUP] “Deciding who is eligible to complain about microaggressions is itself an act by which the majority imposes its will.” [Megan McArdle] And the New Yorker contributes a politically correct “Lord of the Flies.”
As you probably know if you follow the news, a man named Martin Shkreli in charge of a startup firm called Turing Pharmaceuticals bought the rights to a drug called pyrimethamine (brand name Daraprim), used in the treatment of AIDS and malaria, and announced that he was jacking up its price from $13.60 to $750. Massive outrage resulted, which has echoed through social media for the past week.
Pyrimethamine is long since off patent. It is not difficult to manufacture, and sells cheaply in Europe. But under the distinctive food and drug laws of the United States you can’t just start turning out pills in your factory to compete with Shkreli, at least not without compiling and submitting a huge pile of regulatory paper with the U.S. Food and Drug Administration. This calls on the services of lawyers and scientists, costs a lot of money, and takes time, and you might or might not be able to recover the costs from the relatively small pool of users.
The FDA grants market exclusivity to companies that are willing to take “grandfathered” compounds into compliance with their current regulatory framework, and that’s led to some ridiculous situations with drugs like colchicine and progesterone. (Perhaps the worst example is a company that’s using this technique to get ahold of a drug that’s currently being provided at no charge whatsoever).
Among laws that used the “marketing exclusivity” technique to award monopolies on older drugs, on the logic that otherwise no one would step forward to handle the heavy costs of getting those drugs regulatory clearance, were the Drug Price Competition and Patent Term Restoration Act of 1984, better known as the Hatch-Waxman Act, originally introduced by Sen. Charles Mathias (R-Md.), and the Orphan Drug Act of 1983, introduced by Rep. Henry Waxman (D-Calif.) (We covered the issue briefly in this 2011 post.) In various ways that backers appear not to have foreseen, opportunistic actors have succeeded in seizing the legal-monopoly status made available for various compounds without always providing as much public benefit in return as had been expected. To enforce their legal monopoly, some of these companies sue rival drugmakers to force them to pull their competing offerings off the market.
Underlying it all — but seldom asked — was whether the gigantic costs of regulatory approval are really a necessary evil. Libertarian-minded critics were especially inclined to question whether hugely expensive studies and paperwork should really be required in the case of grandfathered or “generally recognized as safe” drugs, many of which have been familiar to the medical profession for decades or even centuries, allowing for a collective sense to emerge of their safety and effectiveness. But the view that progressives tended to champion — which prevailed — was that older compounds and those used for rare diseases should be held to no less stringent a standard than any other, and should either be withdrawn from the market or have their safety and effectiveness proved at someone’s expense.
At the Niskanen Center, Will Wilkinson ties together several of these themes. “Martin Shkreli… bought himself a monopoly made entirely of health-and-safety red tape,” he notes. The most-hated businessperson of the year is “cashing in precisely because the American pharmaceutical market is so far from free.”
Meanwhile, today’s moralistic politicians denounce the resulting fiasco without acknowledging the role of yesterday’s moralistic politicians in helping to bring it about (cross-posted in adapted form at Cato at Liberty).
More: “if another company wanted to compete to sell the same medicine [Daraprim], it would need to apply for a new generic drug approval, by submitting an ‘Abbreviated New Drug Application’ to the FDA. Filing one of these applications with the FDA used to cost as little as $1 million; today it can run as high as $20 million, sometimes more. …On average, it takes about 50 months for the FDA to approve a single generic application.” [Scott Gottlieb, WSJ] To clarify what I should have spelled out above: while exclusivity grants under the 1983 and 1984 laws have been associated with price jumps for a range of older drugs, the ANDA obstacle to entry by itself accounts for Shkreli’s monopoly position, which he cleverly amplified by sharp practices described by Ronald Bailey: “First, he apparently talked Impax [a predecessor holder of the sole FDA rights to market Daraprim] into starving the wholesale market of the drug, so that when Turing completed its purchase of the rights there were no extra pills floating around. Next, he set up an exclusive distribution network as a way of preventing potential competitors from obtaining enough Daraprim to conduct [the equivalence] trials for the FDA” necessary to develop an ANDA so as eventually to challenge his regulatory monopoly. And Scott Alexander at Slate Star Codex adds the Daraprim episode to a list of calamitous failures of generic drug regulation.
- I own a Volkswagen clean diesel myself, and can recommend its terrific fuel economy and peppy performance. It’s almost too good to be true [Clive Crook on policy background] Class action lawyers expect huge payday from scandal, but their emissions might not be very reliable either [Daniel Fisher] More from Fisher: will VW owners actually take their vehicles in for the recall? and more on litigation prospects [More: Car and Driver];
- Housing advocates looking for plaintiffs to sue Bay Area town that refuses to make its housing supply denser [CityLab]
- Behind court’s strikedown of NYC Styrofoam ban [Erik Engquist, Crain’s New York; Entrepreneur]
- “Did Flint, Michigan Just Lead Poison Its Children? Doctors Think So.” [Russell Saunders, The Daily Beast]
- “Global regulatory norms” favored by pontiff “would globalize Argentina’s downward mobility.” [George Will]
- After long silence, Hillary Clinton declares opposition to Keystone XL pipeline [Politico, more]
- Houston: “For the most part, we don’t look all that different from other big cities that do have zoning.” [The Urban Edge; Kinder Institute, Rice U.]
…except that every so often it makes us smile to see people we respect say nice things about us.
— Popehat (@Popehat) July 17, 2015
— Susan Ellingwood (@ellingwood) July 15, 2015
More nice things: the Foundation for Economic Education calls us “indispensable.” And Eric Turkewitz recalls a non-blocking exchange.
I’m interviewed at Vermont Watchdog about the truly terrible idea of aiming a civil RICO/racketeering action or investigation against the forces of “climate denial” over wrongful advocacy. The notion seems to have some well organized friends, including Sen. Sheldon Whitehouse (D-R.I.) and, more recently, twenty scientists who recently signed a letter calling for such a probe. “I have no idea how it affects the First Amendment” says one of the letter’s signers, a Vermont scientist, according to a companion report. I should note that when I speak of RICO in the interview transcript, I am referring to the civil-litigation side of the law (“civil RICO”) as distinct from the law’s other wing, “criminal RICO.”
I note, and reject, the idea that the First Amendment protects only truthful speech and thus has no application here because climate skepticism is false. (As Cato and many others argued in last year’s Supreme Court case of Susan B. Anthony List v. Driehaus, controversial speech need not be true to be protected, and in practice an “only truth has rights” rule would give the state a stifling power to punish advocacy in debates that it considers settled.) In substantial part, I note, debate in Washington (and not just in Washington) proceeds by way of advocates’ deployment of half-truths, selectively marshaled data, scientific studies with agendas, and so forth. It is common for both sides to use these techniques. The same techniques are also accepted as standard currency within the adversary process itself, in which the law takes such pride, which makes it particularly absurd to propose defining it as unlawful racketeering to “use dubious information to advance a cause.”
Among those promoting this bad idea: BoingBoing, often regarded as a pro-free-speech site.
P.S. Adapted together with an earlier post into one at Cato at Liberty.