Overlawyered: Chronicling The High Cost Of Our Legal System

Posts Tagged ‘FDA’

“F.D.A. Halts Coronavirus Testing Program Backed by Bill Gates”

“An innovative coronavirus testing program in the Seattle area — promoted by the billionaire Bill Gates and local public health officials as a way of conducting wider surveillance on the invisible spread of the virus — has been ordered by the federal government to stop its work pending additional reviews….’Please discontinue patient testing and return of diagnostic results to patients until proper authorization is obtained,’ the F.D.A. wrote in a memo.”

Appalling. Now will you believe what libertarians have been trying to tell you about the Food and Drug Administration? [Mike Baker, New York Times; earlier on FDA and COVID-19 testing here]

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Can’t lay your hands on a pulse oximeter? 1976 law, FDA regulation are among reasons

Because low blood oxygen may be an early symptom of serious COVID-19 disease, interest has quickly amounted among consumers and medical professionals in enabling wider access to the decades-old technology. Ordinarily inexpensive and widely available, the small finger-clasp devices are now back ordered on long delays in online commerce. And now for the regulatory rub: “The Apple Watch actually contains hardware to measure blood-oxygen level, but under current FDA regulation, the function is disabled.” And while the old finger-clasp technology is luckily grandfathered in, technologies updating the idea face an onerous path to market under the Medical Device Regulation Act of 1976, which mandates FDA review. “Samsung’s Galaxy phones possessed the capacity to read blood oxygen as well as pulse through its built-in Samsung Health app — until the most recent version, the S20, which suspended the function, likely due to regulatory and legal concerns.” [James Copland, City Journal]

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COVID-19 pandemic roundup

  • “However peaceable we might be in our intentions, our assembling is a physical threat. Our judgments about liberty, I think, need to reflect that.” [Eugene Volokh on freedom of assembly during an epidemic] Suits against quarantine seldom prevail [Chris Dolmetsch and Malathi Nayak, Bloomberg/Claims Journal] Quarantine and public health measures set important precedents in overcoming judges’ suspicion of delegations of power [Keith Whittington]
  • If the federal government decided it wanted to block movement between different states to combat virus transmission, where would it get the legal authority, and what means could it lawfully use? [Gene Healy, Cato] The constitutional background on freedom to travel, as well as search and seizure, during an epidemic [Volokh]
  • “The common law also appears not to be a good alternative. One can imagine the litigation nightmare if everyone who got the virus attempted to identify and sue some defendant for damages.” [Tim Brennan, Truth on the Market]
  • Cracking down on putatively deceptive accounting practices, SEC penalized “‘bill-and-hold’ transaction orders in which a product is not immediately delivered to its customer.” And that was terrible news for anyone in the business of trying to build public health stockpiles — of vaccines, equipment, PPE — that might be needed in a contagious-disease emergency [John Berlau, CEI] Better than compulsory purchase orders: “Using Purchase Guarantees and Targeted Deregulation to Boost Production of Essential Medical Equipment” [Caleb Watney and Alec Stapp, Mercatus Center]
  • Flashpoints include drive-in services, curfews, ID and quarantine of churchgoers: “Religious Freedom Clashes With Public Health Enforcers” [Elizabeth Nolan Brown]
  • “FDA Denaturing Rules Are Toxic for Small Distillers” [Jacob Grier]

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Pharmaceutical and medical device roundup

  • “Feds Say It’ll Take Up To 90 Days to Approve New Mask-Making Facilities” [Christian Britschgi, Reason] “America Could Import Countless More Face Masks if Federal Regulators Would Get Out of the Way” [Eric Boehm] Reversing course, FDA agrees to permit wider use of a system developed by Battelle for sterilizing specialized masks worn by front-line health workers [Rachel Roubein, Politico] In the face of mounting criticism, federal Centers for Disease Control may reconsider guidance discouraging general public from wearing face masks [Joel Achenbach, Washington Post]
  • What would we do without the FDA? “FDA Tells At-Home Diagnostics Companies To Stop Coronavirus Test Roll-Outs; The companies are complying. Customers won’t get their results and are being told to destroy their test kits.” [Ronald Bailey, Reason] Small favors: FDA “is easing up on some regulations so that ventilators can be manufactured and implemented more quickly” to respond to crisis [Scott Shackford]
  • And the same continued: “The idea to expand testing of drugs and other medical therapies was strongly opposed by the FDA’s senior scientists this week, the official said, and represented the most notable conflict between the FDA and the White House in recent memory.” [Tyler Cowen] “FDA Shouldn’t Keep Safe Drugs off the Market” [David Henderson]
  • Off-label or no, “the FDA granted an emergency authorization request to make chloroquine and hydroxychloroquine available from the Strategic National Stockpile (SNS), the federally operated supply of medical equipment and pharmaceuticals for use in public health emergencies.” [Naomi Lopez and Christina Sandefur, In Defense of Liberty (Goldwater Institute); Ronald Bailey; Jim Beck; earlier on off-label prescribing here, etc.] Switch of beverage alcohol firms to making hand sanitizer was advanced by waivers from FDA and Alcohol and Tobacco Tax and Trade Bureau [Jeffrey Miron and Erin Partin]
  • Needless face-to-face consults avoided: “Health Canada Sets A Good Example By Relaxing Opioid Prescribing Rules During COVID-19 Pandemic” [Jeffrey Singer, Cato] Some moves in the right direction in the U.S. too [Singer]
  • Even the New Jersey courts aren’t buying the ambitious theory of “fourth-party payor liability,” in which a plaintiff who never “claimed to have used the product, paid for the product, acquired the product, or had any interaction with the product (or its alleged manufacturers) in any way” nonetheless sues them for supposedly driving up health insurance costs [James Beck, Drug & Device Law]
  • Heartburn drug: “Trial lawyers start search for next big mass tort, increase Zantac ads by more than 1,000%” [John O’Brien, Chamber-backed Legal Newsline]

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Don’t deprecate off-label drug prescribing

Is it questionable and suspicious for doctors to administer a medication that has not been proved effective for the use in question? Nope. It’s perfectly normal. I explain “off-label prescribing” in a new opinion piece at the Washington Examiner, the news hook being the recent flap about chloroquine/hydroxychloroquine as possible treatments for COVID-19. A related Twitter thread is here as well as here, and here’s our earlier coverage of off-label prescribing.

Also related, this recent line from Scott Alexander is so apt: “Just like the legal term for ‘not proven guilty beyond a reasonable doubt’ is ‘not guilty’, the medical communication term for ‘not proven effective beyond a reasonable doubt’ is ‘not effective'”.

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Medical roundup

  • Telemedicine has become a crucial tool during the crisis. 2017 paper discusses the regulatory barriers that had constrained it [Shirley Svorny, Cato Policy Analysis; earlier here, here, and here]
  • “Wondered why it’s been so hard to ramp up production of surgical masks and respirators? Why haven’t private companies flooded into the market to meet peak demand? Because they are regulated medical devices and new versions require FDA approval which can take months to obtain.” [Paul Matzko thread on Twitter]
  • Asking former health care workers to “dust off their scrubs” and return for the emergency raises possible liability exposures [Lori Rosen Semlies, Wilson Elser] “Coronavirus could affect med mal rates: Experts” [Judy Greenwald, Business Insurance]
  • A closer look at certificate of need laws, which suppress hospital bed supply [Eric Boehm, related audio clip with Jeffrey Singer, earlier and more]
  • More on the relaxation of occupational licensure in medical jobs during the emergency [Michael Abramowicz, Jeffrey Singer, earlier]
  • Return with us now to those days not so long ago when public health specialists seemed to be in the paper every day inveighing against alcohol, dietary choices, and such like [Elaine Ruth Fletcher, Health Policy Watch last year on World Health Organization (WHO) rumblings against alcohol; JAMA on furious fight over red-meat recommendations]

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COVID-19 pandemic roundup

  • Get the truckers what they need: reversing itself, Pennsylania agrees to reopen all 17 closed turnpike service plazas, heavily relied on by truck workforce [Ashley, CDL Life]
  • No, Senator, Medicare for All would not have kept us safe: “An Epidemic Big Enough to Accommodate Everyone’s Wish List” [Jacob Sullum] Has spending on the federal Centers for Disease Control and National Institutes of Health been squeezed, gutted, etc.? My colleague Chris Edwards checks the numbers;
  • This is not the first time epidemics have interrupted the Supreme Court in its work [ABA Journal]
  • Medical supplier, speaking anonymously “for fear of FDA retaliation,” says it has large quantities of protective masks ready that cannot be used or even unpacked until FDA gets around to inspection [Tom Rogan, Washington Examiner] As part of liability protection, new bill will allow masks manufactured for industrial uses to be put into health care service [Jeanne Whalen, Washington Post; earlier here and here]
  • Good luck and renewed health to David Lat, founder of Above the Law and longtime friend of this site, who’s on ventilation in a New York hospital with a COVID-19 diagnosis [New York Law Journal, his Twitter and Facebook posts]
  • Emergency measures have a way of bleeding into later policy: “Politicians Declare Eviction Moratoriums To Combat Coronavirus. Will They Give Up That Power After the Virus Fades?” [Christian Britschgi]

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We’ll pay in lives for the testing debacle

“Between early February and mid-March, the U.S. lost six crucial weeks because regulators stuck to rigid regulations instead of adapting as new information came in. While these rules might have made sense in normal times, they proved disastrous in a pandemic.” [Alec Stapp/The Dispatch] When it’s all over, the CDC/FDA testing fiasco is going to go down in the history books, and not in a good way. “We only need to take a look at South Korea to see how we could have been in a better position if we’d let private industry play a larger role in testing.” [Jeffrey Singer/NBC News] “People have talked about ‘drug lag’ but here is a highly quantifiable measure of ‘diagnostic lag’: the excess deaths and hospitalizations the US will suffer thanks to CDRH [the FDA’s Center for Devices and Radiological Health] blocking a standard test. The sheer cost of what the FDA has done is now universally perceptible, undeniable.” [Balaji Srinivasan; earlier here, and this at Cato]

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Pharmaceutical roundup

  • “A federal judge has ordered the nation’s leading pharmacy chains to turn over billions of nationwide prescription records going back 14 years – even as the American Civil Liberties Union and some states attack similar requests by the government as overbroad and an invasion of privacy.” [Daniel Fisher, Legal NewsLine] “Without evidence and unable to make public nuisance argument, Delaware’s opioid claims against Walgreens fail” [same] “Oklahoma Opioid Ruling: Another Instance of Improper Judicial Governance Through Public Nuisance Litigation” [Eric Lasker and Jessica Lu, Washington Legal Foundation, earlier]
  • “Merck v. HHS tests the limits of the federal government’s ability to control and compel commercial speech” [Ilya Shapiro and Dennis Garcia on Cato amicus brief in D.C. Circuit raising First Amendment issues]
  • Let’s try correcting the New York Times on drug pricing. Where to begin? [Molly Ratty, Popehat]
  • “Court Strikes Down NECC Convictions [New England Compounding Center] for Vagueness” [Stephen McConnell, Drug & Device Law]
  • Defense perspective: the ten worst and best prescription drug and medical device decisions of 2019 [Jim Beck, Drug & Device Law]
  • “If there are people out there with no options and they have terrible diseases, we are going to get those drugs to them as fast as feasible.” FDA approving potential breakthrough drugs more speedily [Michelle Fay Cortez and Cristin Flanagan, Bloomberg/MSN; related, Alex Tabarrok]

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