- Apr 2, 2009
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This afternoon, Lorillard and RJ Reynolds filed a lawsuit against the FDA seeking to remove several members of the TPSAC and its Constituents Subcommittee due to conflicts of interest regarding menthol cigarette review, smokeless tobacco products as harm reduction alternatives, litigation against tobacco companies, trade secrets, and the the failure of the FDA to resolve these concerns after being repeatedly informed of them.
I think the 76 page brief (attached at the bottom of this note) makes some compelling arguments.
Lorillard's press release is below.
GREENSBORO, NC Feb. 25, 2011 Highlighting conflicts of interest and bias among members of a Food and Drug Administration (FDA) scientific advisory committee, Lorillard, Inc. (NYSE: LO) today filed suit to stop FDA from receiving or relying on recommendations from the advisory committee, including recommendations regarding the use of menthol in cigarettes. In the complaint, Lorillard also asks the Court to enjoin the FDA from making available to the advisory committee any trade secret or confidential commercial documents submitted by the company to FDA until the advisory committee is lawfully constituted.
The lawsuit was filed jointly by Lorillard and R.J. Reynolds Tobacco Company in the United States District Court for the District of Columbia. The advisory committee is expected to submit a non-binding recommendation on the use of menthol in cigarettes to the FDA by March 23, 2011.
The suit alleges that the Tobacco Products Scientific Advisory Committee as currently constituted fails to meet requirements of the Federal Advisory Committee Act to be fairly balanced and not to be inappropriately influenced by any special interest. Instead, the suit alleges, conflicts of several members of the committee render the panel unable to deliver any report or recommendation to the FDA that is free of the taint of conflicts of interest.
The suit specifically alleges that three members of the committee, Drs. Neil Benowitz, Jack E. Henningfield and Jonathan M. Samet are conflicted because they have made tens of thousands of dollars as paid expert witnesses in litigation against tobacco products manufacturers and due to their continuing financial relationships with pharmaceutical companies that make smoking-cessation products.
Beginning last year, the two companies and others urged the FDA to ensure that members of the panel were free of conflicts. Those concerns, however, were either summarily rejected or entirely ignored.
We are taking this action reluctantly after the FDA failed to constitute the committee in accordance with the law and failed to properly address legitimate concerns regarding fairness and impartiality, said Ronald S. Milstein, senior vice president and general counsel of Lorillard.
About Lorillard, Inc.
Lorillard, Inc. (NYSE: LO) is the third largest manufacturer of cigarettes in the United States. Founded in 1760, Lorillard is the oldest continuously operating tobacco company in the U.S. Newport®, Lorillards flagship menthol-flavored premium cigarette brand, is the top selling menthol and second largest selling cigarette in the U.S. In addition to Newport, the Lorillard product line has five additional brand families marketed under the Kent®, True®, Maverick®, Old Gold® and Max® brand names. These six brands include 41 different product offerings which vary in price, taste, flavor, length and packaging. Lorillard maintains its headquarters and manufactures all of its products in Greensboro, North Carolina. For more information, visit the Companys web site at Lorillard, Inc.: Index.
Forward-Looking Statements
Certain statements made in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, or the Reform Act. Forward-looking statements include, without limitation, any statement that may project, indicate or imply future results, events, performance or achievements, and may contain the words expect, intend, plan, anticipate, estimate, believe, may, will be, will continue, will likely result, and similar expressions. In addition, any statement that may be provided by management concerning future financial performance (including future revenues, earnings or growth rates), ongoing business strategies or prospects, and possible actions by Lorillard, Inc. are also forward-looking statements as defined by the Reform Act.
Forward-looking statements are based on current expectations and projections about future events and are inherently subject to a variety of risks and uncertainties, many of which are beyond our control, that could cause actual results to differ materially from those anticipated or projected. Information describing factors that could cause actual results to differ materially from those in forward-looking statements is available in Lorillard, Inc.s filings with the Securities and Exchange Commission (the SEC), including, but not limited to, our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. These filings are available from the SEC over the Internet or in hard copy, and are available on our website at Lorillard, Inc.: Index. Forward-looking statements speak only as of the time they are made, and we expressly disclaim any obligation or undertaking to update these statements to reflect any change in expectations or beliefs or any change in events, conditions or circumstances on which any forward-View attachment 30774looking statement is based. ###
I think the 76 page brief (attached at the bottom of this note) makes some compelling arguments.
Lorillard's press release is below.
LORILLARD SUIT ALLEGES FINANCIAL CONFLICT AND BIAS
AMONG FDA ADVISORY COMMITTEE MEMBERS
AMONG FDA ADVISORY COMMITTEE MEMBERS
GREENSBORO, NC Feb. 25, 2011 Highlighting conflicts of interest and bias among members of a Food and Drug Administration (FDA) scientific advisory committee, Lorillard, Inc. (NYSE: LO) today filed suit to stop FDA from receiving or relying on recommendations from the advisory committee, including recommendations regarding the use of menthol in cigarettes. In the complaint, Lorillard also asks the Court to enjoin the FDA from making available to the advisory committee any trade secret or confidential commercial documents submitted by the company to FDA until the advisory committee is lawfully constituted.
The lawsuit was filed jointly by Lorillard and R.J. Reynolds Tobacco Company in the United States District Court for the District of Columbia. The advisory committee is expected to submit a non-binding recommendation on the use of menthol in cigarettes to the FDA by March 23, 2011.
The suit alleges that the Tobacco Products Scientific Advisory Committee as currently constituted fails to meet requirements of the Federal Advisory Committee Act to be fairly balanced and not to be inappropriately influenced by any special interest. Instead, the suit alleges, conflicts of several members of the committee render the panel unable to deliver any report or recommendation to the FDA that is free of the taint of conflicts of interest.
The suit specifically alleges that three members of the committee, Drs. Neil Benowitz, Jack E. Henningfield and Jonathan M. Samet are conflicted because they have made tens of thousands of dollars as paid expert witnesses in litigation against tobacco products manufacturers and due to their continuing financial relationships with pharmaceutical companies that make smoking-cessation products.
Beginning last year, the two companies and others urged the FDA to ensure that members of the panel were free of conflicts. Those concerns, however, were either summarily rejected or entirely ignored.
We are taking this action reluctantly after the FDA failed to constitute the committee in accordance with the law and failed to properly address legitimate concerns regarding fairness and impartiality, said Ronald S. Milstein, senior vice president and general counsel of Lorillard.
About Lorillard, Inc.
Lorillard, Inc. (NYSE: LO) is the third largest manufacturer of cigarettes in the United States. Founded in 1760, Lorillard is the oldest continuously operating tobacco company in the U.S. Newport®, Lorillards flagship menthol-flavored premium cigarette brand, is the top selling menthol and second largest selling cigarette in the U.S. In addition to Newport, the Lorillard product line has five additional brand families marketed under the Kent®, True®, Maverick®, Old Gold® and Max® brand names. These six brands include 41 different product offerings which vary in price, taste, flavor, length and packaging. Lorillard maintains its headquarters and manufactures all of its products in Greensboro, North Carolina. For more information, visit the Companys web site at Lorillard, Inc.: Index.
Forward-Looking Statements
Certain statements made in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, or the Reform Act. Forward-looking statements include, without limitation, any statement that may project, indicate or imply future results, events, performance or achievements, and may contain the words expect, intend, plan, anticipate, estimate, believe, may, will be, will continue, will likely result, and similar expressions. In addition, any statement that may be provided by management concerning future financial performance (including future revenues, earnings or growth rates), ongoing business strategies or prospects, and possible actions by Lorillard, Inc. are also forward-looking statements as defined by the Reform Act.
Forward-looking statements are based on current expectations and projections about future events and are inherently subject to a variety of risks and uncertainties, many of which are beyond our control, that could cause actual results to differ materially from those anticipated or projected. Information describing factors that could cause actual results to differ materially from those in forward-looking statements is available in Lorillard, Inc.s filings with the Securities and Exchange Commission (the SEC), including, but not limited to, our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. These filings are available from the SEC over the Internet or in hard copy, and are available on our website at Lorillard, Inc.: Index. Forward-looking statements speak only as of the time they are made, and we expressly disclaim any obligation or undertaking to update these statements to reflect any change in expectations or beliefs or any change in events, conditions or circumstances on which any forward-View attachment 30774looking statement is based. ###
That's the end goal 
