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]

One Comment

  • Re: home-testing. Someone tell President Trump—the FDA will reverse itself.