Posts Tagged ‘FDA’

When regulators retaliate

The uproar continues, and quite properly so (earlier here and here), over the threats of Boston Mayor Thomas Menino and Chicago alderman Proco (“Joe”) Moreno to exclude the Chick-Fil-A fast-food chain because they disagree (as do I) with some of the views of its owner. Among the latest commentary, the impeccably liberal Boston Globe has sided with the company in an editorial (“which part of the First Amendment does Menino not understand?…A city in which business owners must pass a political litmus test is the antithesis of what the Freedom Trail represents”), as has my libertarian colleague Tom Palmer at Cato (“Mayor Menino is no friend of human rights.”)

The spectacle of a national business being threatened with denial of local licenses because of its views on a national controversy is bad enough. But “don’t offend well-organized groups” is only Rule #2 for a business that regularly needs licenses, approvals and permissions. Rule #1 is “don’t criticize the officials in charge of granting the permissions.” Can you imagine if Mr. Dan Cathy had been quoted in an interview as saying “Boston has a mediocre if not incompetent Mayor, and the Chicago Board of Aldermen is an ethics scandal in continuous session.” How long do you think it would take for his construction permits to get approved then?

Thus it is that relatively few businesses are willing to criticize the agencies that regulate them in any outspoken way (see, e.g.: FDA and pharmaceutical industry, the), or to side with pro-business groups that seriously antagonize many wielders of political power (see, e.g., the recent exodus of corporate members from the American Legislative Exchange Council).

A few weeks ago I noted the case of Maryland’s South Mountain Creamery, which contends through an attorney (though the U.S. Attorney for Maryland denies it) that it was offered less favorable terms in a plea deal because it had talked to the press in statements that wound up garnering bad publicity for the prosecutors. After that item, reader Robert V. wrote in as follows:

Your recent article about the [U.S. Attorney for Maryland] going after the dairy farmers reminded me a case in New York state where the Health Department closed down a nursing home in Rochester. They claim is was because of poor care, the owner claims it was because he spoke out against the DOH.

The state just lost a lawsuit where the jury found the DOH targeted the nursing home operator because he spoke out against them.

According to Democrat and Chronicle reporters Gary Craig and Steve Orr, the jury found state health officials had engaged in a “vendetta” against the nursing home owner:

Beechwood attorneys maintained that an email and document trail showed that Department of Health officials singled out Chambery for retribution because he had sparred with them in the past over regulatory issues. The lawsuit hinged on a Constitutional argument — namely that the state violated Chambery’s First Amendment rights by targeting him for his challenges to their operation.

The Second Circuit panel opinion in 2006 permitting Chambery/ Beechwood’s retaliation claim to go forward is here. It took an extremely long time for the nursing home operators to get their case to a jury; the state closed them down in 1999 and the facility was sold at public auction in 2002.

Food roundup

  • Chicago city government joins Boston in threatening to use regulation to punish Chick-fil-A for its political views [Josh Barro, Eugene Volokh, earlier, Tim Carney]
  • NYC hearing on Bloomberg soda ban “a pre-scripted event with a foregone conclusion” [ACSH, WLF] despite inclusion of Baylen Linnekin on witness list [Reason, Jacob Sullum] If calories are the point: “Hey, Mayor Mike, why not ban beer?” [Sullum, NYDN]
  • California restaurants serving foie gras “can be fined up to $1,000…or is it a tax?” [Fox via @ReplevinforaCow]
  • When nutrition labeling meets deli salads: the FDA invades Piggly Wiggly [Diane Katz, Heritage]
  • “Raw Milk Advocates Lose the Battle But Win the War” [ABA Journal]
  • “PLoS Medicine is Publishing An Attack On ‘Big Food'” [David Oliver]
  • More signs that Mayor Bloomberg is eyeing liquor as a public health target [NYP, earlier] Oasis in the putative food desert: “In praise of the corner liquor store” [Katherine Mangu-Ward, Reason]

Medical roundup

  • How’d we get shortages of hospital and community sterile injectables? Check out the role of FDA Good Manufacturing Practice (GMP) regs, warning letters, and resulting plant closures [Tabarrok, with comments controversy; earlier here, here, here, etc.]
  • California orthopedist sues, wins damages against medical society that took action against him based on his testimony for plaintiff in liability case [American Medical News; earlier here, etc.]
  • Can’t have that: medical apology should be opposed because it “can create an emotional connection with an injured patient that makes the patient less likely to ask for compensation.” [Gabriel Teninbaum (Suffolk Law), Boston Globe]
  • Feds’ war on painkillers is bad news for legit patients and docs [Reuters, Mike Riggs/Reason]
  • New federal pilot project in Buffalo will provide concierge-style home care to emergency-department frequent fliers. Spot the unintended consequence [White Coat]
  • Dastardly drug companies? Deconstructing Glaxo SmithKline’s $3 billion settlement [Greg Conko, MPT] More: Beck, Drug and Device Law, on suits over “what are mostly medically valid and beneficial off-label uses”. Paging Ted Frank: “HIPAA’s Vioxx toll” thesis may depend on whether one accepts that the premised Vioxx toll has been established [Stewart Baker, Ted’s recent post]
  • U.K.: “Lawyers seizing lion’s share of payouts in NHS negligence cases” [Telegraph]
  • Silver linings in SCOTUS ObamaCare ruling? [Jonathan Adler and Nathaniel Stewart] “DNC Scientists Disprove Existence of Roberts’ Taxon” [Iowahawk humor] Did Ginsburg hint at the court’s direction on the HHS contraception mandate? [Ed Morrissey, Hot Air]

[cross-posted at Cato at Liberty]

The costs of the FDA, compounded

As exclusivity is granted based on the staggering costs of clearing the FDA steeplechase, low-cost consumer options have a way of disappearing: “KV priced Makena like so many other branded drugs at $1,500 per injection. Had there been no compounding market at about $15 per injection, virtually no one’s sense of propriety would have been ruffled and perhaps no one would have even noticed.” [Charles Hooper, Medical Progress Today]

“The quiet scandal of the HIV home test kit”

“Did the FDA’s former ban on home testing kits result in thousands of avoidable infections?” Persons who learn of their HIV-positive status are less likely to pass the infection on to others. “The scandal is that the approval of a rapid home test for HIV did not occur until last week — about 24 years after the FDA received its first application seeking permission to market one.” [Roger Parloff, Fortune](& welcome Hans Bader/CEI readers)

Senate votes to continue gun-toting FDA raids

Amish raw-milk farmers beware: as Mike Riggs reports at Reason, Senator Rand Paul of Kentucky introduced an amendment that would have curtailed the power of Food and Drug Administration agents to carry firearms and make warrantless arrests — the agency would still have retained many other legal weapons with which to secure compliance with its will — but the amendment failed by a 78-15 vote. The 15 are listed here.

April 9 roundup

November 29 roundup

  • UK: “Premiums to soar as accident claims lawyers push up cost of motor insurance, MPs hear” [Telegraph]
  • John Stossel on death by FDA [Reason] Disapproving stance on e-cigarettes might cost lives [Balko] Company abandons pioneering stem-cell research after running up $45 million in costs to win FDA approval of initial safety tests [Technology Review] NYT can be obtuse about regulatory costs [Cowen]
  • No, we’re not allowed to let you out of the van to relieve the call of nature [Ted at PoL]
  • “Economic Damages Are Affirmed Though Plaintiff’s Earnings Rose After Accident” [NJLJ]
  • A shame about the business climate in Hawaii [Inverse Condemnation]
  • “Massachusetts Lawyer Loses License for a Year for Charging $93.8K Contingent Fee, Absent a Contingency” [Martha Neil, ABA Journal]
  • Movement “rapidly gaining steam” in U.S. to prohibit anonymous sperm donation [Glenn Cohen, Prawfs]