“While any and all potential risks should be
investigated, this release by the FDA is incredibly
irresponsible. There is absolutely nothing to suggest
that these seizures were caused by vaping”
– American Vaping Association
(including ‘Orally Inhaled Nicotine-Containing Drug Products’). These
would be distinct from the usual e-cigarette, which is classed as a
recreational tobacco product, not a therapeutic drug.
This pathway is a potential alternative for e-cigarette manufacturers
facing the daunting Premarket Tobacco Applications (PMTA)
deadline. This will require products for sale in the US to undergo
extensive tests before gaining market approval.
Azim Chowdhury is a regulatory and public policy attorney at Keller
and Heckman LLP specialising in vape, nicotine and tobacco product
regulation.
He told this magazine:
“You have to consider all those types of factors, develop studies
and surveys, data, to address those population-level questions
for a PMTA.
The attorney believes that the so-called teen vaping epidemic in
the US has created a new sub-arena for approved products to
help young people quit the nicotine products they are currently
using, such as tobacco products like e-cigarettes.
The development of new drugs is of significant financial interest
to the FDA.
The Prescription Drug User Fee Act allows the FDA to collect funds
from pharmaceutical companies developing new products. Between
1992 when the act was past and 2016, the pharmaceutical
industry contributed $7.67 billion (that’s roughly £6 billion) to the FDA,
according to healthcare consultancy firm, Avalere.
But regardless of the FDA’s motives, the seizure warning could
have a lasting impact on adult smokers wanting to switch to a less
harmful alternative.
Chowdhury agrees.
“No e-cigarettes have been able to do that yet so it’s not quite
clear what the FDA’s going to require. We’re still waiting for their
final guidance on the PMTA process.” “Given the youth situation, [the FDA wants to] put as much information
out there as possible to dissuade young people from using these
products.
Mr Chowdury believes that smaller US companies will have
more difficulty making it through either the PMTA or New Drug
Application (NDA) process. “A consequence of that is adult smokers who could benefit from
these products may not do so because they’re seeing these
things that are basically scaring them away from e-cigarettes.”
“I think the pharmaceutical companies are in the best position
because they do have experience, they can build off of their own
nicotine products and take advantage of the situation in the US right
now which is a lot of people using nicotine who weren’t before.”
VM23 | 19