Six uncomfortable regulatory truths in a pandemic
These are truly extraordinary times. With supply chains breaking down and demand outstripping supply for critical products such as ventilators, masks and test kits, both regulators and industry are having to do things very differently. But amongst all of the panic and all of the generously volunteered goodwill, it’s important to keep some rigour and structure amongst the chaos. Here are six things that should be front of mind for regulators and manufacturers alike.
1. Regulators still need to regulate – but fast
A typical regulatory review time for a Ventilator or a Class 3 IVD can be six months to a year or more, depending on the market and the agency.
That just won’t cut it right now.
So regulators are bending rules as much as they can. But it’s really important that they don’t break the rules. History shows that rushed decisions in emergencies can do more harm than good. Who remembers tainted blood scandals with imperfect screening in the HIV pandemic? Just yesterday it emerged that some Conavirus tests distributed by the US CDC were faulty. Luckily the problem was picked up quickly by the State public health labs and is being fixed, after some regulatory gymnastics from FDA to allow state labs to participate in reagent development – but it all takes precious time.
Australia’s TGA is approving COVID-19 tests based on less evidence than perhaps might have been the case in the normally rigorous, meticulous TGA process, but they still require evidence that provides a reasonable assurance of safety and performance for emergency use.
Which brings me to…
2. Risk Benefit balance still applies – but hey, ventilators keep you breathing
Not breaking regulatory rules means still focusing on the patient risks vs. clinical benefits. Now regulators (and the rules they work within) tend towards risk aversion. But hey, when the choice is between a kludged together ventilator from an automotive factory and no ventilator at all, it’s pretty clear there’s still a net patient benefit. It’s good to see the UK MHRA convening expert advisors to figure out quickly just what the truly essential requirements are for a ventilator, and the US FDA relaxing rules on design change notifications to allow ventilator manufacturers flexibility on component sourcing as they ramp up production.
3. Time is precious
Regulators are overloaded with all of this, and right now their time is precious. And every man and his dog are calling up their national regulator or health department with offers of devices and test kits which may help. This is all very well intentioned. But before seeking that urgent pre-consultation, ask yourself: “do I really have something right now that’s backed with sufficient evidence to pass even an expedited and streamlined emergency review?” If not, then perhaps it’s better to keep out of the way.
4. Trust is a lubricant
There’s a fascinating story in Malcolm Gladwell’s book The Tipping Point about how Toyota’s over-lean, just-in-time, supply chain almost brought the car giant undone as a factory fire took out the single source of brake valves for all of the company’s cars and light trucks. Toyota re-established production in just two weeks and was back up to full scale in around a month. This was done with the help of direct competitors and a wide network of contacts including a loan of a production line by Nissan and technical help from sewing machine manufacturers and jewellery technicians. The point was it was done without any written contracts and in a spirit of greater national interest. The whole remarkable exercise worked because of trust. In fearful times, trust is perhaps all too scarce – but it’s needed now more than ever. When working together in a crisis, trust is an essential lubricant.
5. There’s no need to change the rules
Pandemic planning has long been a part of regulators’ strategic outlook. As a result, regulators already have the tools they need to act quickly and prioritise what matters. Here in Australia TGA has powers to expedite reviews, to relax things like restrictions on point of care testing for serious diseases, or to make emergency supply exemptions for unapproved medicines or devices.
There’s generally no need for rule changes.
6. Data really is King
Manufacturers who can contribute to the efforts to defeat the pandemic need to be equally nimble and to understand how to navigate the existing regulatory pathways efficiently.
Most of all, if you seek expedited treatment, be ready to provide the hard data to allow the regulators to do a speedy job.
If you’re considering an approach to any regulator and would like to understand the logistics, the requirements, or you’d just like to better understand your current product, be sure to reach out to us. We’ve got a fantastic team ready to answer any of your questions.
Need to navigate expedited or Emergency regulatory pathways? We are experienced in dealing directly with regulatory authorities and can offer rapid support. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)
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