NJOY hires Big Pharma regulatory affairs director and Big Pharma researcher (in preparation for FDA e-cig regs)

[Bill Godshall]

njoy hires Big Pharma regulatory affairs director and researcher
http://www.cspnet.com/category-mana.../articles/njoy-expands-senior-management-team

Graham, in a newly created position, will oversee all regulatory affairs in the U.S. and abroad. Graham was previously senior director of international government affairs at Johnson & Johnson, where he led tobacco control-related public policy for key markets around the globe. Before joining Johnson & Johnson, he was senior director of global public policy for Pfizer, where he led public policy for their tobacco Dependence business. Graham is a graduate of Columbia University School of International & Public Affairs with a Masters in Public Policy & Administration. He has more than 20 years of experience with tobacco control, smoking cessation and related regulatory reforms.

Rabinowitz comes to NJOY on a leave of absence from Princeton University, where he is a full professor in the Department of Chemistry and the Lewis-Sigler Institute for Integrative Genomics. Rabinowitz received both an M.D. and Ph.D. from Stanford University. Thereafter, he co-founded Alexza Pharmaceuticals, where he invented the Adasuve Inhaler for treatment of acute agitation, an FDA-approved inhalation drug product. Rabinowitz is an inventor of more than 130 U.S. patents and author of more than 110 major journal articles, including seven in the past four years in Science or Nature.

 

[sqirl1]

Question:
What kind of regulations does N-joy want to go for? Are they for the "Let's get rid of anything with juice in it so people can only sell prefilled cartridges like us and ban all flavors and apply the PACT act to E-cig products" kind of regulations or do they actually want an open market like what we have today? In other words is this good or bad?

 

[Placebo Effect]

From a speech David Graham made last week

And so let no one be in any doubt; we support regulation, but not regulation that is as defined for tobacco.

The one phrase I would like to really emphasize, to borrow a British expression, is mind the gap. There needs to be a gap between how one looks at tobacco regulation designed for that purpose and regulation that is intended to be applied for e-cigarettes. And we believe at NJOY that we're increasingly well placed to deal with that should it come forward.

We oppose subjecting e-cigarettes to the same grandfather date as tobacco cigarettes, which could potentially force e-cigarettes off the market in the interim period.

• We oppose subjecting e-cigarettes to the same pre-market approval requirements as tobacco cigarettes that could stifle innovation.

• We oppose the prohibition of advertising of e-cigarettes on TV.

• We oppose forcing e-cigarettes to the back counter of stores where big tobacco has almost an effective monopoly.

• And we oppose prohibition of sampling of e-cigarettes to age-verified adults that really give them an opportunity to see what these products are, what they look like, how they feel and whether they could truly offer the potential of an alternative.

So, we want to work with the public health community. We want to work with regulators and we want to stand together to work purposefully to obsoleting tobacco cigarettes and potentially save unnecessary death and disease. We don't sell tobacco products. It's not ever our intention to do so. We don't believe we have any conflict. And if anybody's taking sides on here, we're on the side of public health.

NJOY's Board isn't going to shed a tear if the FDA regulates bottled nicotine liquid out of existence, but I doubt they'll be pushing it. Their main focus right now should be and probably is continuing to survive and grow as the big players come in and encroach on their side of the market.

 

[low_tar_neil]

Well, Njoy originally pushed for medicinal regulation in Europe, and look where that left them

 

[rothenbj]

Well, Njoy originally pushed for medicinal regulation in Europe, and look where that left them

Fought it in the US courts.

 

[drtwain5]

Interesting and predictable. BT is unlikely to "make" or "draft" new ecig policy but to comply with new regs instead, assuring their own survival at the expense of hundreds/thousands of small manufactures and vendors (tanks, eliquid, cartos, mods, attys etc). This requires big $ and significant understanding of the FDA regulatory machine (e.g., safety/tox, pharmacology, clinical research). If interested, please PM for strategic approach.

 

[rothenbj]

Interesting and predictable. BT is unlikely to "make" or "draft" new ecig policy but to comply with new regs instead, assuring their own survival at the expense of hundreds/thousands of small manufactures and vendors (tanks, eliquid, cartos, mods, attys etc). This requires big $ and significant understanding of the FDA regulatory machine (e.g., safety/tox, pharmacology, clinical research). If interested, please PM for strategic approach.

I view the only real issue is whether the FDA will attempt to regulate the source of nicotine. If the attempt to regulate a tamper proof, cartridge as the only source of liquid, hopefully the suppliers are strong enough to fight the regulations. It is really the only thing that can really impact the AVP market. There is no way they can regulate that hardware unless it is sold with liquid. If the regulate the flavors they will allow, there is no way to regulate unflavored liquid. Flavor mixtues can be sold sans nicotine and the consumer can control that aspect.

However, if they attempt to eliminate the nicquid market totally, we will be screwed unless the battle is fought.

 

[drtwain5]

This is highly contentious and the source of concern. Nic delivery in vivo is not only dependent on the actual starting concentration, but on the efficiency of the device used to power vaporization and particle dispersion for inhalation. Accordingly, any part of the product (from eliquid +/- nic, organoleptics, wrap materials in cartos, refillable tanks, you get the idea) are likely to be lumped for FDA regulation. In the UK, ecig will be regulated as medical devices in 2016, and a schedule to ban flavors and menthol has already been announced.