Hmmm...
I'm not sure when this was published, but it was after March 2011. It's anti-tobacco, but makes interesting points.
http://publichealthlawcenter.org/si...urces/tclc-fda-tobacco-products-apps-2015.pdf
"With its sophisticated knowledge of the tobacco Control Act and instinct for profit-seeking at the expense of public health, the tobacco industry orchestrated a massive exploitation of this loophole in the new product authorization process.
"The industry flooded the FDA with Provisional SE reports just before the March 22, 2011 deadline, bringing the total number of Provisional SE reports to 3,517. This activity is striking considering that the industry filed only 959 Regular SE reports after March 22, 2011, and only 63 total product applications under the pathways that are entirely subject to premarket review (4 PMTAs and 59 SE Exemption requests).
"This means that 77% of the 4,539 applications that the FDA has received to allow new products to enter the market were submitted through the loophole that allows the industry to sell the products before they can be reviewed by the FDA."
As I previously posted:
A 2012 investigation by the Associated Press found that the FDA had received nearly 3,500 of these "substantial equivalence" applications since the law took effect in 2009. The agency was expected to rule on these applications within ninety days of receipt. At the end of 2012 it had issued zero rulings, with many applications lingering for years.
Link to AP article: http://bigstory.ap.org/article/fda-review-tobacco-products-grinds-halt
I'm not sure when this was published, but it was after March 2011. It's anti-tobacco, but makes interesting points.
http://publichealthlawcenter.org/si...urces/tclc-fda-tobacco-products-apps-2015.pdf
"With its sophisticated knowledge of the tobacco Control Act and instinct for profit-seeking at the expense of public health, the tobacco industry orchestrated a massive exploitation of this loophole in the new product authorization process.
"The industry flooded the FDA with Provisional SE reports just before the March 22, 2011 deadline, bringing the total number of Provisional SE reports to 3,517. This activity is striking considering that the industry filed only 959 Regular SE reports after March 22, 2011, and only 63 total product applications under the pathways that are entirely subject to premarket review (4 PMTAs and 59 SE Exemption requests).
"This means that 77% of the 4,539 applications that the FDA has received to allow new products to enter the market were submitted through the loophole that allows the industry to sell the products before they can be reviewed by the FDA."
As I previously posted:
A 2012 investigation by the Associated Press found that the FDA had received nearly 3,500 of these "substantial equivalence" applications since the law took effect in 2009. The agency was expected to rule on these applications within ninety days of receipt. At the end of 2012 it had issued zero rulings, with many applications lingering for years.
Link to AP article: http://bigstory.ap.org/article/fda-review-tobacco-products-grinds-halt
