Posts Tagged ‘FDA’

December 12 roundup

  • “Scott Gottlieb’s FDA Is Moving Toward a Stealth Ban on Cigarettes and Cigars” [Jacob Grier, Reason]
  • Supreme Court should take Melissa and Aaron Klein cake-refusal case from Oregon and resolve the issues of free expression it dodged in Masterpiece [Ilya Shapiro and Patrick Moran, ABA Journal, earlier on Melissa and Aaron Klein cake-refusal case including oppressive $135,000 fine levied by Oregon BOLI (Bureau of Labor and Industries)]
  • “Administrative Law Is Bunk. We Need a Bundesverwaltungsgericht” [Michael Greve, responses from Mike Rappaport, Philip Wallach, and Ilan Wurman, and rejoinder from Greve]
  • New York’s family court system is failing children and their families [Naomi Riley/City Journal, thanks for quote]
  • “The Emmys People Are Opposing A Pet Products Company Named After A Dog Named ‘Emmy'” [Tim Geigner, TechDirt]
  • Metaphor alert: “Lawmaker Injured by Flying Constitution” [Kevin Underhill, Lowering the Bar, and funny throughout]

Medical roundup

Medical roundup

  • Wrong on many other issues, the American Medical Association is right to resist an artificial 3-day limit on opiate prescriptions [Jeffrey Singer, Cato; Jacob Sullum]
  • “Does Ride-Sharing Substitute for Ambulances?” [Leon S. Moskatel and David J. G. Slusky, Cato Research Briefs in Economic Policy No. 114]
  • Fourth Circuit tosses Maryland law banning “price gouging” of “essential” generic drugs, finding that state violates Dormant Commerce Clause by presuming to control transactions entirely outside its boundaries [Zack Buck, Bill of Health; Stephen McConnell, Drug and Device Law]
  • President Trump signs “right to try” legislation expanding right of terminally ill patients to enter unapproved therapies; squaring this with existing FDA regulation may present knotty problems [Michael Cannon, Cato; Michael Maharrey (“In fact, victories in 40 state legislatures preceded Trump’s signing ceremony”); earlier here, here, and at Cato Unbound last year] More cautions from Jim Beck on liability angle [Drug and Device Law]
  • Florida, departing from other states’ practice, caps its outside lawyers’ recovery at $50 million: “Latest Wave Of State Opioid Lawsuits Shows Diverging Strategies And Lawyer Pay Scales” [Daniel Fisher, Forbes]
  • In medical innovation, “equality is a mediocre goal. Aim for progress.” [Tyler Cowen]

Finally, rules to rein in agency guidance documents

Agencies use informal guidance documents in lieu of formal regulation to clarify and interpret uncertainties in existing law and enforcement. Unfortunately, this and other forms of “subregulatory guidance” can also offer a tempting way to extend an agency’s power and authority into new areas, or ban private actions that hadn’t been banned before, all without going through the notice and comment process required by regulation, with its protections for regulated parties. Fair? Lawful? The Department of Justice under Jeff Sessions has lately sought to bring agency use of guidance documents under better control, and in particular end the use of documents that 1) are obsolete, 2) improperly use the process to circumvent the need for formal regulation, or 3) improperly go beyond what is provided for in existing legal authority. I’m interviewed about all this by Caleb Brown for the Cato Daily Podcast.

More: Charlie Savage, New York Times (DoJ revokes batch of guidance documents), Matt Zapotosky/Washington Post; Scott Shackford, Reason (rescission of guidance letter on local fines and fees should be read not as blessing those practices as okay, but as reflecting fact that federal government lacks clear statutory or constitutional mandate to intervene against them); Stephen McConnell, Drug and Device Law (“DOJ Says its Litigators May Not Use Noncompliance with FDA Guidances as Basis for Civil Enforcement Actions”).

Medical roundup

Medical roundup

  • Burdensome though it is in other ways, HIPAA does not create a private right of action, so no big-ticket damage suits. Connecticut high court rides to rescue by creating new tort for breach of medical confidentiality [Steven Boranian, Drug and Device Law]
  • Details of cases aside, once again, should federal law really be requiring healthcare employers to grant religious exemptions to staff unwilling to undergo flu vaccination? [Department of Justice press release on suit against Ozaukee County, Wisconsin; earlier on EEOC settlement against North Carolina hospital]
  • First Amendment should come into play when FDA bans drug providers from making truthful statements about their therapies [Henry Miller and Gregory Conko, Reason] And a Cato panel discussion on FDA regulation of speech with former Vascular Solutions CEO Howard Root (author of “Cardiac Arrest”), Christina Sandefur of the Goldwater Institute, and Jessica Flanigan of the University of Richmond, moderated by Cato’s Michael Cannon;
  • “Uberizing Nonemergency Medical Transportation” [Ann Marie Marciarille, Prawfsblawg]
  • “Protecting Reasonable Physician Choice in Medical Product Cases” [Luther Munford, Drug and Device Law]
  • Britain’s National Health Service lurches toward crisis in negligence payouts [BBC, Paul Goldsmith, Centre for Policy Studies]

Medical roundup

  • “The dominant narrative about pain treatment being a major pathway to addiction is wrong, [and] an agenda heavily weighted toward pill control is not enough.” [Sally Satel on origins of opioid crisis]
  • The press gets it wrong: “A Young Mother Died Because Her Flu Meds Were Too Expensive – Or Did She?” [Josh Bloom, ACSH]
  • New research brief: tort reform could have effects in both directions on innovation [Alberto Galasso and Hong Luo, Cato]
  • Appalling: editor of The Lancet extols Marx as a guide to understanding medical science [Theodore Dalrymple, Law and Liberty]
  • “We harbor a suspicion that half the drug/device tort cases we encounter are really medical malpractice cases in search of a deeper pocket” [Stephen McConnell, Drug & Device Law Blog]
  • Should the Food and Drug Administration concern itself with the effect of its decisions on drug prices? [David Hyman and William Kovacic, Regulation mag]

Pharmaceutical roundup