Judge Leon denies FDA motion to dismiss suit.

Federal judge says cigarette makers’ suit over FDA tobacco review panel can move forward

Associated PressBy Michael Felberbaum, AP Tobacco Writer | Associated Press 

RICHMOND, Va. (AP) — A federal judge says a challenge by two major cigarette makers alleging conflicts of interest in a federal advisory panel’s review of tobacco products can move forward.

In an order posted Wednesday, U.S. District Court Judge Richard Leon in Washington denied the Food and Drug Administration’s motion to dismiss the suit filed by Lorillard Inc. and R.J. Reynolds Tobacco Co. The suit alleges financial conflict of interest and bias by several members of the Tobacco Products Scientific Advisory Committee.

The panel advises the FDA on tobacco-related issues, including the public health impact of menthol cigarettes and dissolvable tobacco.

Lorillard, based in Greensboro, N.C., makes the top-selling Newport menthol brand. R.J. Reynolds, based in Winston-Salem, N.C., sells brands including Camel and Pall Mall, as well as dissolvable tobacco products.


#1 Candy Girl on 08.01.12 at 11:57 AM

Wow. The FDA just can’t catch a break from Judge Leon. This ruling only serves to support the contention that the FDA is becoming weary of getting sued AND LOSING. That’s why the commotion about a deeming reg and e-cigarettes is a bit overblown. The FDA knows that any attempt to unilaterally deem e-cigs subject to Chapter IX of the FSPTCA will be met with multiple lawsuits and, as a result, it will attempt to strike a deal with large tobacco companies, large stand-alone e-cig companies and, believe it or not, big pharma. At the end of the day it’s not the FDA that e-cig supporters have to worry about- it will be the guys they bring to the negotiation table. The negotiators will be about business implications and initiatives- not about consumers!

#2 Copenhagen Charley on 08.01.12 at 1:18 PM

Gotta love this Judge!

#3 sdf@sdf.com on 08.02.12 at 12:42 PM

I don’t think the Agency is going to have some yahoo e-cig guy tell them how to regulate the product.

#4 Candy Girl on 08.02.12 at 6:19 PM

Why not? They let big pharma dictate regulations for devices and drugs and they want big tobacco’s buy in for cigarettes. They’re not going to let any yahoo tell them what to do, but they will seek input from Lorillard and any other big tobacco companies- they are all about helping their “stakeholders.” After all, the stakeholders and the fees they pay are the FDA’s primary source of operating revenue. sdf- I cant’t tell if you’re too cynical or not cynical enough!!

#5 sdf@sdf.com on 08.03.12 at 10:43 AM

Candy Girl big pharma does not dictate what the FDA does. Congressmen, even Senators jump for them, but companies get knee capped every day by the Agency. Frankly, Ashley’s background from the CDC makes him even more immune to any industry. Had the CTP been staffed from the Agency it probably would have been a bit more industry friendly. But those relationships take time to build. CTP is a new entity, with a lot of folks who unlike their FDA counterparts on the drug side do *not* dream of a cushy job with big tobacco (or big pharma). Just my opinion!

#6 Bill Godshall on 08.09.12 at 3:50 PM

If Obama isn’t reelected in November, the likelihood of FDA proposing and/or approving the “deeming” regulation will greatly diminish.

Had it not been for Obama’s appointing many anti tobacco extremists at FDA, CDC and other federal health agencies, none of this would have occurred.

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