Case 3:09-md-02100-DRH-PMF Document 2223-2 #24855 Filed 12/30/11 Page 1 of 7 Page ID FILED UNDER SEAL EXHIBIT B . Gase Document 2223-2 Filed 12/30/1 1 Page 2 of 7 Page Under Seal December 20, 2011 Via Electronic- Mail Honorable David R. Herndon Chief Judge United States Dist1?ict Court Southem District of Illinois 750 Missouri Avenue East St. Louis, IL 62201 Re: In re Yasmin and Yaz (Drospirenone) Marketing and Sales Practices and Products Liability Litigation, MDL No. 2100 Dear Chief Judge Hemdon: Plaintiffs are unhappy with the results of the recent FDA Advisory Committee meeting relating to and Yasmin(R). The Committee voted that, for the general population of i- women who desire contraceptives, the benefits of DRSP-containing oral contraceptives for prevention of pregnancy outweigh the risks of those contraceptives. See Transcript of Reproductive Health Drugs and Drug Safety, and Risk Management Advisory Committee at 108 (Dec. 8, 2011) (Ex. A). Plaintiffs suggest that, but-for alleged conflicts of interest of tive i AdComm members, the Committee would have voted that the risks outweigh the benefits, which would have compelled the FDA to pull the medicine from the market. See Letter from R. Denton to C.J. Hemdon at 1 (Dec. 15, 2011). Not even plaintiffs' hired experts have opined that YAZ and Yasmin should be . withdrawn from the market. See, e. g, Blume Dep. (Ex. B) at 61 :20-24 (declining to opine on whether YAZ and Yasmin should be withdrawn as birth control option); Parisian Dep. (Ex. C) at 208: 14-209:9 (same); Gerstman Dep. (Ex. D) at 50:3-7 (same). Nor have the researchers on whom plaintiffs rely: RICHARD KNOX: . . . Susan Jick of Boston University is a co-author of both new studies [about Yasmin]. She says the clot risk is still small and women have different reactions to different birth control pills, so it's important to have choices. But in light of current evidence, Jick knows what she would tell her daughter. Professor SUSAN JICK (School of Medicine, Boston University): Start on one of the older pills that has a demonstrated lower risk. And if that works for you, that's great. And if not, yes, then you can try one of the others. That's what I would do. JOHN E. - jgalvln@foxgalvin.com St. Louls Offlce: One South Memorlel Drive, Twelfth Floor - St. Louls. Mlssourl 631 02 Office: 51 1 1 West Mein Street - Belleville, 62226 Phone 3 1 4-588-7000 - Toll Free 866-588-7001 - Fax 314-588-1965 - ?Case Document 2223-2 Filed 12/30/1 1 Page 3 of 7 Page ID #24857 . ..7.. . .. I R. Knox, FDA Issues Warning About Some Birth Control Pills, (June 1, 2011). i . Nevertheless, plaintiffs now assert that the AdComm vote must have been the product of conflicts of interest and therefore ask this Court to allow them to use confidential discovery materials from this litigation to attack five members of the Committee. This argument should be rejected for three reasons. First, this Court already has ruled that plaintiffs may not use confidential documents produced in this litigation in their efforts to i influence the outcome of regulatory proceedings related to YAZ and Yasmin. Second, the FDA - already has a procedure in place for assuring that advisory committee members do not have conflicts proscribed by law. Plaintiffs have established no basis for allowing them to use confidential discovery materials to second guess that process and attack committee members. . Third, nothing in the documents cited by plaintiffs establishes a conflict under FDA standards. 1. This is not the first time that plaintiffs have asked this Court to allow them to make wider use of confidential discovery materials produced for purposes of this litigation. In September, when this Court ordered Bayer to supplement document production and to produce - AdComrn preparatory materials on a rolling basis, the Court made clear that plaintiffs could not use discovery materials to "interfere with or influence the outcome" of the upcoming advisory committee hearing: With regard to the requested advisory committee materials and or custodial file materials produced in connection with this Order, the Court ORDERS the plaintiffs to treat such material as confidential. The material is not -- under any circ@tances - to be produced to any third parties. In particular, this confidential material shall not be produced or - shown to any experts or other witnesses in preparation for approaching advisory committee hearings. This material is being produced solely for use in this litigation. It shall not be used by plaintijfs to interfere with or influence the outcome of any pending advisory committee hearings. See CMO 39 1977] at 2 (italics added, other emphasis original). Two months later, when plaintiffs argued that they had a First Amendment right to provide discovery materials to the FDA and its AdComm,?the Court again rejected their argument: Plaintiff gained access to the disputed documents solely through the discovery process. The documents are not filed with the Court. Further, plaintiff is not restricted from disseminating the subject information if obtained through other means. Therefore, based on the holdings of Seattle Times and Bond, the Court finds preservation of CMO 7 will not violate plaintiffs First Amendment right to petition the govermnent provided defendant makes the requisite showing of "good cause" ptusuant to 26(c). CMO 45 2081] at 4. See also id at 5. 2 . Case Document 2223-2 Filed 12/30/1 1 Page 4 of 7 Page ID #24858 . Plaintiffs' December 15 letter ignores these orders, which apply here and bar plaintiffs from using confidential discovery materials as part of regulatory submissions. Plaintiffs have provided no basis for departing from these holdings. -j i . . 2. Plaintiffs would have this Court believe that submission of these docrunents is . necessary to allow the FDA to police purported conflicts of interest among AdComm members. But plaintiffs ignore that the FDA already has detailed standards and procedtues for determining whether conflicts exist and whether an individual should participate in an AdComm. i 2 Under Section 7l2(c)(2) ofthe Federal Food, Drug, and Cosmetic Act, a conflict exists when a person "has a financial interest that could be affected by the advice given 21 U.S.C. -. Similarly, under 18 U.S.C. 208 (the government-wide statutory provision), a conflict exists when a person "has a financial interest" in an affected organization. And the. . government-wide regulations, 5 C.F.R. similarly explain that a conflict exists when a person "has or seeks a business, contractual or other financial relationship that involves other than a routine consumer transaction." All of these provisions use the present tense verb, "has." The financial disclosure provision of the FDA's Guidance on AdCom1n meetings similarly focuses on present relationships, and provides: The law requires that FDA's advisory committee members who are special Govemment employees (SGEs) or regular Government employees (RGEs) disclose to FDA potential financial interests related to the topic of the advisory committee meeting, including relationships that they may have with the sponsor and competitors of the product(s) under discussion . . . See "Guidance for the Public, FDA Advisory Committee Members, and FDA Staffi The Open Public Hearing at FDA Advisory Committee Meetings," Final Guidance (December, 2010) - (Ex. E) at 7-8. In addition to its general guidance on advisory committee procedrues, the FDA has issued . a specific guidance document on potential conflicts of interest for committee members. That - document expressly states that "[d]isqualifying financial interests include only financial interests i that are currently held." See Guidance for the Public, FDA Advisory Committee Members, and FDA Staf`f` on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Cormnittees at 12 (August 2008) (Ex. F). Pursuant to this guidance, every prospective advisory committee member must complete Form FDA 3410 and disclose all current financial interests. See Form FDA 3410, Confidential Financial Disclosure Report for Special 5 Government Employees (Ex. G). Moreover, although by statute the FDA is required to focus on - present financial interests, the FDA also collects information on expert witness, speaking and writing activities in the previous year and past financial matters.! Id at 2. Thus, the FDA also 5 I The FDA focuses its historic review on the past twelve months. This concept appeared in a March 2007 FDA draft guidance, where the agency wrote, "Although financial interests that are not currently held do not constitute a conflict of interest under 18 U.S.C. 208, we believe that the public may perceive some previously held financial interests in organizations potentially affected 3 - i i 'Case Document 2223-2 Filed 12/30/1 1 Page 5 of 7 Page ID #24859 - has the information to determine whether a past relationship might give rise to an appearance of conflict. 5 C.F.R. These standards do not require advisory committee members 3 to be without any history of interactions with industry. To the contrary, because the FDA wants persons with genuine expertise, it routinely includes advisory committee members who, because of their expertise, have worked with indust1?y. See FDA, "Questions and Answers Regarding i Advisory Committee Membership" (stating that AdComms include industry representatives and "shou1d be knowledgeable in risk risk management, drug safety, and medical, behavioral, and biological sciences as they apply to risk management, and drug abuse") (Ex. H). Plaintiffs may disagree with the standards established by Congress and implemented by the agency. But their views, formed in the context of litigation,-are not controlling. The FDA has detailed procedures for applying statutory conflict standards. As shown below, those standards were applied here and plaintiffs' list of documents does not demonstrate that the challenged AdComm members had disqualifying conflicts under FDA Guidance. . 3. Plaintiff`s have challenged five AdComm members who voted in favor of keeping . YAZ and Yasmin on the market: Anne Burke, Eve Espey, Sean Hennessey, Paula Hillard, and Julia Johnson. Bayer has searched the database that would track any payments to these individuals and the only items entered on this database for the past year are payments by sales representatives for lunches in the offices of Dr. B1u?ke (seven lunches) and Dr. Johnson (three lunches). The value attributed to the most expensive of these lunches was less than twenty dollars. Cheap lunches do not constitute a "financial interest that could be affected by the advice given" at an advisory committee. 21 U.S.C. The documents cited by plaintiffs do not suggest any departure from FDA conflict of interest standards. Virtually all of the documents concern activities years ago. And many of 1 plaintiff`s' characterizations of the doctunents are grossly inaccurate and deliberately misleading. The most Cg1'EURgl0l.lS example is plaintiffs' attempt to imply that Sean Hemiessey - .. participated in Bayer's mock advisory committee exercises. For instance, plaintiffs characterize 566 (Ex. I) as follows: - This document includes emails between Bayer employees and Sean Hennessey discussing Hennessey's participation in Bayer's mock advisory committee meeting, in by advisory committee recommendations as problematic. Accordingly, we intend to implement a - policy of generally limiting participation when a member has a financial interest within the preceding twelve months that would be a disqualifying financial interest if it were currently held, I even though full participation would be permitted under 18 U.S.C. 208." I -gdl0001 .pdfZ Although this language did not appear in the final guidance, FDA nevertheless concentrates on potential conflicts within the year preceding an advisory committee meeting. - 4 Case Document 2223-2 Filed 12/30/1 1 Page 6 of 7 Page ID #24860 - - in in which on performanu ce before the Advisory Committees and the public on December 8, 2011. Pls' Ex. A at 2. Plaintiffs know, however, that Dr. Hennessey dal not particqzate in any such moot because Dr. Hennessey is listed as unavailable for the mock advisory committee in (Ex. J). P1aintif`fs cite this document in their chart, but misrepresent its contents, saying: "This doctunent includes a list of Bayer's consultants. Sean Hennessey is listed as a Consultant on Bayer's DRSP External List."' Pls' Ex. A at 2.2 Similarly, document 14 (Ex. K) at 2 shows that Dr. Hennessey was unavailable to participate in the moot. The document does not include any correspondence with Dr. Hennessey. But plaintiffs misrepresent the doctunent as follows: This document includes emails between Bayer employees and Sean Hennessey discussing Hermessey's participation in Bayer's mock Advisory Committee i meeting, in which Bayer would rehearse and receive feedback on their eventual performance before the Advisory Committee and the public on December 8, 201 1. i Pls' Ex. A at 2. In short, the documents cited by plaintiffs to suggest Dr. Hennessey should have been disqualified from the AdComm show only that Bayer considered him as a participant in a mock advisory committee exercise and that Dr. Hennessey did not participate in that exercise. These materials do not suggest that Dr. Hennessey had a conflict of any sort, much less provide a basis for allowing plaintiffs to take confidential documents produced in this litigation and use those documents to attack him. As for the other four AdComm members who are challenged by plaintiffs, Bayer has been able to identify only two documents on p1aintif`fs' chart that fall within the year preceding the AdComm meeting. See supra, at note 1. One of those documents, which mentions Dr. Burke, was not even designated as conhdential} The other document, dated August 2011, lists Dr. Hillard among potential advisory board members for a meeting in October 2011, but describes Dr. Hillard's attendance status as "unknown." See (Ex. L). At bottom, plaintiffs want to fashion their own conflict-of-interest standard and use it to attack AdComm members with whose votes they disagree. But FDA already has applied its conflict of interest standards and has concluded these individuals were appropriate participants in the AdComm. Indeed, the FDA specifically stated at the AdComm meeting on December 8 that 2 Plaintiffs should have known that their representation was wrong from one of the other docmnents included in their chart. See (Ex. I) at 1 (stating that S. Hem1essey" is not on the current com1nittee"). This is just one of 21 documents in Plaintif`f`s' Exhibit A that were not designated confidential. - 1 Case Document 2223-2 Filed 12/30/1 1 Page 7 of 7 Page ID #24861 . - .. .. .. . . . . . the agency had performed a conflict review as to all committee members and fotmd no disqualifying conflict: - FDA has determined that members and temporary voting members of these committees are in compliance with federal ethics and conflict of interest laws. . . Related to the discussion of today's meeting, members and temporary voting members of the committees have been screened for potential financial conflicts of interest of their own, as well as those imputed to them, including those of their spouses or minor children, and for purposes of 18 USC, Section 208, their employees. These interests may include investments, consulting, expert witness i testimony, contracts, grants, CRADAs, teaching, speaking, writing, patents and royalties and primary employment. Advisory Committee Transcript (Ex. A) at 3-4. In sum, this Court has twice rejected attempts by plaintiffs to use in their advocacy before the FDA confidential documents produced in discovery in this litigation. Plaintiffs have provided no reason to revisit those rulings here. The FDA has standards and procedures for determining whether prospective advisory committee members have disqualifying conflicts. It applied those standards and procedures here. Plaintiffs have ignored those standards and mischaracterized the doctunents listed in the chart they provided to this- Court.4 The Court . should therefore deny their request to lift the confidentiality designation of Bayer's documents. Re ly sub itted, Jo . E. Gavin cc: Plaintiff`s' Liaison Counsel (via electronic mail) Moreover, plaintiffs have ignored the process set forth in CMO 7 291] at 20-21, which requires - them to confer with Bayer about any request to dedesignate confidential documents and specifies procedures that must be followed before bringing such a request to this Court. 6