Posts Tagged ‘FDA’

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]

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'”.

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]

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]

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]

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]

After outbreak of bootleg-vape injuries, government restricts aboveboard vaping products

1) Batches of black-market vaping products, mostly containing THC rather than nicotine and used to get high, turn out to contain adulterants, most likely Vitamin E acetate, known to be harmful when inhaled. Over a period of weeks, hundreds of users fall seriously ill and several die in a classic “bad batch” episode familiar to epidemiologists and those who study the Drug War. [Erin Schumaker, ABC News]

2) Government reacts by banning a range of lawful nicotine vaping products sold in stores, none of which have been implicated in the deaths or injuries.

3) Predictable result: to drive some nicotine vape users back to cigarette smoking, and others toward sources of black-market supply. Good job, government! What problem would you like to fix next?

[Kimberly Leonard and Cassidy Morrison, Washington Examiner; Federalist Society Regulatory Transparency Project video featuring Sally Satel; Slate podcast with Jacob Grier; Jeffrey Singer, New York Daily News]

More: “Might restricting e-cigarette flavors actually increase smoking? (And acculturate vapers to tobacco flavors?) There’s actually some research on that” [Jonathan Adler on Twitter] Plus: trial lawyers circle vaping industry [Brendan Pierson, Reuters]

Pharmaceutical roundup

Medical roundup

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]