If a product submits an application for a new product approval or substantial equivalence determination within the allotted 24-month period, it will not be taken off the market while the review of the application is pending.

The World Health Organization or WHO on Tuesday August 26th 2014 issued a report calling for the ban of indoor usage of electronic cigarettes claiming yet again there isn’t enough research done on these devices for it to be considered safe to use as well as being a potential gateway for children into nicotine addiction.

In my view, this refutation and undermining of its own black box warning violates accepted standards of pharmaceutical company conduct, and should prompt either penalties or the removal of the drug from the market. If Pfizer is going to publicly undermine the required black box warning, then clearly that warning is not adequate to protect consumers and the FDA must either penalize Pfizer so that it desists from this behavior or pull the drug from the market since it is becoming clear that the company is undermining that warning in the eyes of the public.

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