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®: CRE Regulatory Action of the Week
Tobacco Companies Sue FDA over Advisory Committee Bias and Conflicts
On February 25, 2011, Lorillard, Inc., Lorillard Tobacco Company, and R.J. Reynolds Tobacco Company sued the Food and Drug Administration in the United States District Court for the District of Columbia. Their complaint alleges anti-tobacco bias and conflicts of interest by some members of the FDA’s Tobacco Products Scientific Advisory Committee (“TPSAC”) and by some members of TPSAC’s Constituents’ Subcommittee.
According to the complaint, this bias and these conflicts violate several federal laws and taint the final report on menthol cigarettes that TPSAC is scheduled to release on March 23, 2011. Lorillard and Reynolds ask the court to issue an order barring FDA from receiving or relying on this or any report issued by TPSAC until and unless the committee is reconstituted in a manner that eliminates the bias, conflicts and other flaws identified in the complaint. Only then could TPSAC issue a valid and reliable report on menthol or on any other subject.
A copy of the complaint is available online at http://thecre.com/pdf/mentholcomplaint1.pdf. The FDA has not yet responded to it.
This litigation raises issues that are important to many other Federal Advisory Committee Act (“FACA”) committees. Consequently, CRE will track this case and post a series of articles on it. This first article summarizes the claims and factual allegations.
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Tobacco Companies Sue FDA over Advisory Committee Bias and Conflicts
On February 25, 2011, Lorillard, Inc., Lorillard Tobacco Company, and R.J. Reynolds Tobacco Company sued the Food and Drug Administration in the United States District Court for the District of Columbia. Their complaint alleges anti-tobacco bias and conflicts of interest by some members of the FDA’s Tobacco Products Scientific Advisory Committee (“TPSAC”) and by some members of TPSAC’s Constituents’ Subcommittee.
According to the complaint, this bias and these conflicts violate several federal laws and taint the final report on menthol cigarettes that TPSAC is scheduled to release on March 23, 2011. Lorillard and Reynolds ask the court to issue an order barring FDA from receiving or relying on this or any report issued by TPSAC until and unless the committee is reconstituted in a manner that eliminates the bias, conflicts and other flaws identified in the complaint. Only then could TPSAC issue a valid and reliable report on menthol or on any other subject.
A copy of the complaint is available online at http://thecre.com/pdf/mentholcomplaint1.pdf. The FDA has not yet responded to it.
This litigation raises issues that are important to many other Federal Advisory Committee Act (“FACA”) committees. Consequently, CRE will track this case and post a series of articles on it. This first article summarizes the claims and factual allegations.
TPSAC was established by the 2009 Family Smoking Prevention and Tobacco Control Act (“TCA”), which also authorizes the FDA to regulate tobacco products. The complaint describes TPSAC’s duties as follows:
“ In general, as set forth on the FDA’s website, available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/default.htm , the TPSAC ‘advises the Commissioner of Food and Drugs or designee in discharging responsibilities as they relate to the regulation of tobacco products, reviews and evaluates safety, dependence, and health issues relating to tobacco products, and provides advice, information and recommendations to the Commissioner of Food and Drugs.. . . The Committee may provide recommendations to the Secretary regarding any regulations to be promulgated under the act . . . .”
TPSAC consists of nine voting members and three nonvoting industry representatives. It has been operating since the first quarter of 2010. FDA’s website describes TPSAC’s composition as follows:
“Committee Membership
The Committee shall consist of 12 members including the Chair. Members and the Chair are selected by the Commissioner or designee from among individuals knowledgeable in the fields of medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products. Members will be invited to serve for overlapping terms of up to fours years. Almost all non-Federal members of this committee serve as Special Government Employees. The Committee shall include nine technically qualified voting members, selected by the Commissioner or designee. The nine voting members shall be physicians, dentists, scientists, or health care professionals practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, or any other relevant specialty. One member shall be an officer or employee of a state or local government or of the Federal Government. The final voting member shall be a representative of the general public. In addition to the voting members, the Committee shall include 3 non-voting members who are identified with industry interests. These members shall include one representative of the tobacco manufacturing industry, one representative of the interests of tobacco growers, and one representative of the interests of the small business tobacco manufacturing industry. This final position can be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the committee.”
There are TPSAC subcommittees which have members who are not on the main TPSAC committee. The TPSAC Constituents Subcommittee membership is shown online at
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/UCM225585.pdf
Lorillard, Reynolds and other industry representatives have repeatedly and unsuccessfully complained administratively to FDA that some members of TPSAC and its Constituents Subcommittee have anti-tobacco bias and conflicts of interest. The litigation complaint makes these administrative complaints in court. For example, it alleges that some members have received funding for research or consultation work from drug makers who make smoking-cessation products. The complaint also alleges that some members serve as paid expert witnesses in lawsuits against tobacco companies. The complaint focuses in particular on alleged conflicts and biases that affect TPSAC’s consideration of issues relating to menthol in cigarettes and its consideration of issues relating to smokeless tobacco products.
The complaint asks the court to issue an order declaring that these alleged biases and conflicts violate the following federal statutes and regulations:
“FIRST CAUSE OF ACTION
Financial Conflicts of Interest
(5 U.S.C. § 706(2)(A); 18 U.S.C. §§ 202(a), 208(a); FDCA § 712, 21 U.S.C. § 379d-1;
and 5 C.F.R. pts. 2635, 2640)
SECOND CAUSE OF ACTION
Appearance Conflicts of Interest
(5 U.S.C. § 706(2)(A); 18 U.S.C. §§ 202(a), 208(a); FDCA § 712, 21 U.S.C. § 379d-1;
and 5 C.F.R. pts. 2635, 2640)
THIRD CAUSE OF ACTION
Violation of the FACA
(5 U.S.C. § 706(2)(A), 5 U.S.C. app. 2 § 5)”
The complaint also asks the court to order
“(a) That the Defendants are enjoined from receiving, considering, or relying
on any report, information, assessment, judgment, recommendation, or other advice provided by the TPSAC, except a report, information, assessment, judgment, recommendation, or other advice provided by the TPSAC when it and, as applicable, its Constituents Subcommittee are composed and operating in accordance with the law.
(b) That the Defendants are enjoined from transmitting, or otherwise making
`available, to the TPSAC or to its Constituents Subcommittee any of the Plaintiffs’ trade secret or confidential commercial documents or other trade secret or confidential commercial information provided heretofore by any of the Plaintiffs to any of the Defendants unless and until the TPSAC or the Constituents Subcommittee, as relevant, is lawfully composed; and that the Plaintiffs need not produce to any of the Defendants any trade secret or confidential commercial documents or other trade secret or confidential commercial information that otherwise would be provided to the TPSAC or to its Constituents Subcommittee unless and until the TPSAC and/or the Constituents Subcommittee, as relevant, is lawfully composed.
(c) That the Defendants are enjoined from excluding nonvoting members of
the TPSAC from activities of the Committee in which the nonvoting members would not have access to trade secret or confidential commercial information (other than trade secret or confidential commercial information submitted by a party that has consented to such access).
(d) That, until the TPSAC is properly composed in accordance with the applicable ethics requirements and the FACA, the Defendants shall attach to the cover of any final report or other document prepared by the TPSAC a disclaimer stating that the report or other document, as applicable, was prepared by a committee constituted in violation of applicable ethics rules and the Federal Advisory Committee Act.”
In subsequent articles we will take a closer look at some of the complaint’s causes of action and requested relief.
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