Pandemic Pushes Bureaucratic FDA To Relax Restrictions On Respirators

P. Gardner Goldsmith | March 25, 2020
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Some light is seeping through the bureaucratic clouds during these dark COVID-19 times.

According to a March 22 press release, the US Food and Drug Administration are lightening their “restrictions” on who can, and how they can, manufacture and sell respirator-ventilators.

Of this “granting permission” to modify designs a bit, and for manufacturers of other products to shift production into the respirator field, the "regulators" said:

First, the guidance describes the agency’s intention to exercise enforcement discretion for certain modifications to these FDA-cleared devices. Normally, any time a manufacturer or user makes a modification to a ventilator device, for instance, adding wireless and/or Bluetooth capability for remote monitoring, those modifications can often trigger an FDA premarket review, which can delay the time it takes to get these devices to the bedside.

How nice of them. To provide some perspective, the hidden costs generated by the very existence of the FDA and the spheres of manufacture over which it claims “regulatory” power are so astronomical, economist and economic historian Robert Higgs edited an entire book about the problem, and has written extensive articles on it.

Here’s just a bit of information to keep in mind, long after the FDA press releases fade away. As Higgs notes, the FDA doesn’t even pass its own standards for “safety and effectiveness”:

After systematically weighing the good and bad effects of the FDA’s drug regulations, Dr. Dale H. Gieringer concluded that "the FDA fails its own criterion [safety and effectiveness] for public health," generating far greater harm than benefit. Many studies by economists have confirmed that the huge expense and years of delay associated with the agency’s product approval process discourage pharmaceutical research and development.

Hopefully, folks can take that insight with them, do their research about the problem, and offer their thoughts to others. Goodness knows, the FDA doesn’t explicitly take responsibility for the thousands whom the agency has prevented from getting life-saving tech due to time delays and heaped-on expenses.

They do, however, come close as one dives deeper into their new “Respirators” press release…

The guidance also helps manufacturers ramp up their manufacturing by adding production lines or alternative sites, for instance, using non-medical device manufacturers such as automobile manufacturers, to start manufacturing ventilator parts. In recognition of the current pandemic situation, and to ease regulatory burden on manufacturers, the FDA is being flexible in not enforcing the premarket review requirement for these modifications.

Shucks. Thanks for the “flexibility” there, pals! And there’s more, from your friendly, neighborhood FDA:

Second, as outlined in this guidance, hospitals and health care professionals may use ventilators intended for other environments. For example, the guidance notes hospitals that could repurpose ventilators normally used for transporting patients in an ambulance into the hospital setting for long-term use. The FDA also provides recommendations for other alternatives that should be considered such as devices for treating sleep apnea, continuous positive airway pressure (CPAP), devices.

Again, thanks, feds.

Some might see this as a positive development, and, sure, it is an improvement to see the lightening of regulatory mandates so that people can more flexibly and immediately respond to the market demand for respirators and creative alternatives to the old paradigm.

But it would be a case of Stockholm Syndrome to thank the FDA for stepping ever-so-slightly aside and beneficently blessing us with a bit more of the freedom we’re really supposed to have in the first place. The idea that desperate medical workers and sick people might have to wait and check with a “Food and Drug Administrator” before repurposing something in an immediate life or death situation is Kafkaesque. It’s like something Terry Gilliam might have shot for the pandemic-time-travel classic, “Twelve Monkeys”.

And this “lightening of the load” doesn’t offer any kind of permanence or assurance that the FDA will not sometime increase the load. Take the debate over Plaquinil, for example. Plaquinil, the better-known name for the drug hydroxychloroquine is showing repeated successes all over the world in the effort to stop the COVID-19 virus from utilizing one of the ACE receptors in the lungs. Plaquinil has been used safely under doctor supervision for decades by people with Lupus, RA, and some other autoimmune diseases, and I’ve known about it because I had to take it once back in the 1990s. It’s a derivative of quinine, the bitter stuff found in tiny amounts in tonic water, and the stuff given to World War Two fighters like my father to fight malaria when they were in the Pacific Islands north of Australia. And, of course, many people who have suffered from leg cramps have found relief by taking quinine pills they could buy over the counter.

But the FDA and President Trump are at slight loggerheads right now over whether Plaquinil will be given the government “green light” for “parallel use” to fight COVID-19.

The FDA has a “process”, you see. First, it has to be shown by the drug maker that the drug is “safe”. But, as Dr. Mary Ruwart writes in her brilliant new book, “Death by Regulation”, in 1962, the FDA amended its “process” and added more… Now, even drugs that have been deemed “safe” must also prove to the government that they are “effective.” And the “effective” requirement starts all over again when someone wants to try a drug to alleviate a different malady.

All of which harms innovation and sees patients suffer.

Let’s remember that the FDA holds all Americans in such a way, and a free market can and does provide the innovation, safety, and security – without taxation or threat – that the FDA cannot.