No. 12-122 IN THE Supreme Court of the United States MCNEIL-PPC, INC., v. Petitioner, CHRISTINA HOYT HUTTO AND ERIC HUTTO, ET AL., Respondents. ON PETITION FOR A WRIT OF CERTIORARI TO THE LOUISIANA THIRD CIRCUIT COURT OF APPEAL BRIEF FOR THE CONSUMER HEALTHCARE PRODUCTS ASSOCIATION AND THE PERSONAL CARE PRODUCTS COUNCIL AS AMICI CURIAE SUPPORTING PETITIONER ROBERT A. LONG, JR.* GERALD F. MASOUDI CHRISTOPHER H. PRUITT EMILY S. ULLMAN COVINGTON & BURLING LLP 1201 Pennsylvania Ave, N.W. Washington, DC 20004 (202) 662-6000 August 27, 2012 *Counsel of Record
TABLE OF CONTENTS Page TABLE OF AUTHORITIES... ii INTERESTS OF AMICI CURIAE... 1 STATEMENT... 3 REASONS FOR GRANTING THE WRIT... 7 I. The Monograph Process Sets Forth FDA s Determinations of the Conditions For Marketing OTC Monograph Products...7 II. Under the Court s Decision in PLIVA, Inc. v. Mensing, Failure to Warn Claims Regarding the Labeling of OTC Monograph Drugs are Preempted Because Manufacturers Cannot Unilaterally Change Their Labels... 12 CONCLUSION... 17 - i -
TABLE OF AUTHORITIES Page(s) CASES Ciba Corp. v. Weinberger, 412 U.S. 640 (1973)...5 Durovic v. Richardson, 479 F.2d 242 (7th Cir. 1973)...6 PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011)... 13, 14, 15 United States v. 1,048,000 Capsules... Afrodex, 494 F.2d 1158 (5th Cir. 1974)...6 United States v. 118/100 Tablet Bottles, 662 F. Supp. 511 (W.D. La. 1987)...6 United States v. 225 Cartons... Fiorinal With Codeine No. 1 and Foiorinal with Codeine No. 2, 871 F.2d 409 (3d Cir. 1989)...5 United States v. 50 Boxes More or Less, 909 F.2d 24 (1st Cir. 1990)...5 United States v. Articles of Drug... 5,906 Boxes, 745 F.2d 105 (1st Cir. 1984)...5 United States v. Articles of Drug... Colchicine, 442 F. Supp. 1236 (S.D.N.Y. 1978)...6 - ii -
United States v. Articles of Drug... Promise Toothpaste for Sensitive Teeth, 826 F.2d 564 (7th Cir. 1987)...5 United States v. Articles of Drug... Hormonin, 498 F. Supp. 424 (D.N.J. 1980)...6 United States v. Atropine Sulfate 1.0 (Article of Drug) Dey Dose, 843 F.2d 860, 861-64 (5th Cir. 1988)...5 United States v. Mosinee Research Corp., 583 F.2d 930 (7th Cir. 1978)...6 United States v. Sene X Eleemosynary Corp., Inc., 479 F. Supp. 970 (S.D. Fla. 1979)...6 United States v. Seven Cardboard Cases... 100 Capsules NDC, ESGIC, with Codeine Capsules, 716 F. Supp. 1221 (E.D. Mo. 1989)...6 United States v. Undetermined Quantities of a Drug, Anucort HC Suppositories, 857 F.2d 1464 (3d Cir. 1988)...5 United States v. Vital Health Products, Ltd., 786 F. Supp. 761 (E.D. Wisc. 1992)...6 United States v. X Otag Plus Tablets, 602 F.2d 1387 (10th Cir. 1979)...6 Weinberger v. Bentex Pharm., Inc., 412 U.S. 645 (1973)... 5, 6, 12, 15 - iii -
Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609 (1973)... 5, 12, 15 Wyeth v. Levine, 129 S. Ct. 1187 (2009)... 13 STATUTES 1938 Food Drug and Cosmetic Act, Pub. L. No. 75-717, 52 Stat. 1040 (1938)...3 201(p), 52 Stat. 1041-42... 4 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301-399d...2 21 U.S.C. 321(p)(2)... 4 21 U.S.C. 331(d)... 12 21 U.S.C. 333(a)... 12 Drug Amendments of 1962, Pub. L. No. 87-781, 76 Stat. 780 (1962)...4 102(a)(2), 76 Stat. 781... 4 102(b)-(d), 76 Stat. 781-82... 4 107(c), 76 Stat. 788... 4 - iv -
FEDERAL REGULATIONS 21 C.F.R. 10.85... 10 21 C.F.R. 314.70(c)(6)(iii)... 13 21 C.F.R. 314.150(b)(10)... 14 21 C.F.R. Part 330...7 21 C.F.R. 330.1... 7, 8, 15 21 C.F.R. 330.10(a)... 7, 8, 9 21 C.F.R. 330.11... 8 OTHER AUTHORITIES Aerosol Drug and Cosmetic Products Containing Zirconium, 42 Fed. Reg. 41,374 (Aug. 16, 1977) (codified at 21 C.F.R. 310.510)... 10 Certain Halogenated Salicylanides as Active or Inactive Ingredients in Drug and Cosmetic Products, 40 Fed. Reg. 50,527 (Oct. 30, 1975) (codified at 21 C.F.R. 310.508)...9 CHPA White Paper on the Benefits of OTC Medicines in the United States, Pharmacy Today, October 2010, available at http://www.chpa-info.org/media/ resources/r_6842.pdf...3 - v -
FDA, Compliance Policy Guide 440.110 app. (2011)... 7, 9 FDA, Compliance Policy Guide 450.200 (1995)... 10 FDA, Rulemaking History for OTC Topical Antimicrobial Drug Products, http://www. fda.gov/drugs/developmentapprovalprocess/ DevelopmentResources/Over-the-Counter OTCDrugs/StatusofOTCRulemakings/ ucm070821.htm (Dec. 14, 2009)...9 FDA, Rulemaking of OTC External Analgesic Drug Products, http://www.fda.gov/drugs/ DevelopmentApprovalProcess/ DevelopmentResources/Over-the-Counter OTCDrugs/StatusofOTCRulemakings/ ucm155846.htm (Dec. 15, 2009)...9 Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-The- Counter Human Use; Tentative Final Monograph, 53 Fed. Reg. 46,204 (proposed Nov. 16, 1988) (to be codified at 21 C.F.R. Part 343)... 8, 9 Letter from Charles M. Breen, District Director, to Steve D. Smith, President, Tec Laboratories, Inc. (Apr. 18, 2011)... 11 - vi -
Letter from Emma R. Singleton et al., to Stacy Lyles, Medavir Medical Advances, Inc. (Apr. 28, 2011)... 11 Letter from LaTonya M. Mitchell, Denver District Director, to Boyd Ronald Johnson, CEO, Quadex Pharmaceuticals, LLC, (May 7, 2012)... 11 Letter from Michael M. Levy, Jr., Esq., Director, Division of New Drugs and Labeling Compliance, to Roger D. Griggs, Chairman, Union Spring Pharmaceuticals, LLC (May 23, 2011)... 11 Letter from Richard L. Friedman, Director, Division of Manufacturing and Product Quality, Office of Compliance, to Goh Bee Leong, General Manager, Haw Par Healthcare Limited (July 20, 2010)... 11 Letter from Teresa C. Thompson, District Director, Cincinnati Division, to Donald Nelson, President and CEO, JD Nelson and Associates, LLC (April 18, 2011)... 11 McNeil Consumer Healthcare, Citizen Petition to Amend the Tentative Final Monograph for Internal Analgestic, Antipyretic and Antirheumatic Drug Products for Over-the- Counter Use - Expanded Age Groups for OTC Consumer Dosing Instructions covering Acetaminophen, Docket No. 77N-0094 (Feb. 1, 1999)... 12 - vii -
Note, Drug Efficacy and the 1962 Amendments, 60 Geo. L.J. 185 (1971)...4 Peter Barton Hutt et al., Food and Drug Law: Cases and Materials (3d ed. 2007)...4 Procedures for Classification of Over-the- Counter Drugs, 37 Fed. Reg. 9464 (May 11, 1972) (codified at 21 C.F.R. 130.301)...6 Proposal Establishing Rule Making Procedures for Classification, 37 Fed. Reg. 85 (proposed Jan. 5, 1972) (to be codified at 21 C.F.R. 130.301)...6 - viii -
INTERESTS OF AMICI CURIAE The Consumer Healthcare Products Association ( CHPA ) is the not-for-profit association representing the makers of over-the-counter ( OTC ) medicines and nutritional supplements and the consumers who rely on these healthcare products. 1 CHPA is one of the oldest trade associations in the United States. It has more than 70 active members that manufacture or market OTC medicines and nutritional supplements, as well more than 120 associate members that provide goods and services to the active members. CHPA is committed to promoting the increasingly vital role of OTC medicines and nutritional supplements in America s healthcare system through science, education, and advocacy. Among its many activities, CHPA shares information with partners across the globe to promote the safe and responsible use of OTC medicines. CHPA also monitors legal issues that affect its members, as well as the entire industry, and offers its perspectives in cases that raise such issues. Based in Washington, D.C. and founded in 1894, the Personal Care Products Council ( PCPC ) is the leading national trade association representing the 1 Pursuant to this Court s Rule 37.6, amici confirm that no counsel for a party authored this brief in whole or in part, that no party or counsel for a party made a monetary contribution intended to fund the preparation or submission of this brief, and that no person other than amici or their counsel made a monetary contribution to its preparation or submission. All parties have consented in writing to the filing of this brief and their letters of consent have been lodged with the Clerk. - 1 -
global cosmetic and OTC personal care products industry. The Council s more than 600 member companies manufacture, distribute, and supply the vast majority of finished personal care products marketed in the U.S. As the makers of a diverse range of products millions of consumers rely on every day, from sunscreens, toothpaste and shampoo to moisturizer, lipstick and fragrance, personal care products companies are global leaders committed to product safety, quality and innovation. PCPC monitors legal and regulatory issues that affect its members and offers perspectives in cases, such as this one, that raise such issues. This case presents the issue of whether state-law failure-to-warn claims regarding the labeling of an OTC drug subject to the Food and Drug Administration ( FDA ) OTC monograph process are preempted by the Federal Food, Drug, and Cosmetic Act ( FDCA ), 21 U.S.C. 301-399d, and its implementing regulations. That issue is of vital importance to the many CHPA and PCPC members that market products under the monograph system. Because FDA s monographs specify the conditions under which a drug is generally recognized as safe and effective and exempt from the requirement of new drug approval, manufacturers of these products risk enforcement action under the FDCA (and criminal prosecution) if they depart from the labeling requirements set forth by FDA. Respondents claim that manufacturers should label their OTC products in a manner inconsistent with the applicable final or tentative monograph would permit CHPA s and PCPC s members to avoid state-law liability only by risking federal enforcement. - 2 -
STATEMENT OTC drugs are an essential part of the healthcare system. Americans rely on OTC drugs for the treatment and prevention of many commonly occurring conditions, including musculoskeletal pain, headaches, the common cold, allergies, heartburn, dermatitis, obesity, tobacco smoking dependence, and dental caries. A 2001 survey commissioned by the National Council on Patient Information and Education found that 598 of the 1,011 adult Americans surveyed (59%) had used an OTC medicine in the past 6 months. CHPA White Paper on the Benefits of OTC Medicines in the United States, Pharmacy Today, October 2010, at 69 (citing Harris Interactive/National Council on Patient Information and Education, Attitudes and Beliefs about the Use of Over-the-Counter Medicines: a Dose of Reality (2002)), available at http://www.chpainfo.org/media/resources/r_6842.pdf. The OTC monograph system at issue in this case is the primary method through which OTC drugs come to market in the United States. The system has its origins in the 1962 amendments to the FDCA, which required, for the first time, that FDA determine whether drugs were effective for their intended uses. The 1938 Food Drug and Cosmetic Act, Pub. L. No. 75-717, 52 Stat. 1040 (1938), provided for premarket review of drugs for safety but not efficacy. The crux of the 1938 Act s premarket review system was the concept of a new drug defined in relevant part as one not generally recognized by experts as safe for use under the conditions prescribed, - 3 -
recommended, or suggested in the labeling thereof ( GRAS ). 201(p), 52 Stat. at 1041-42; Note, Drug Efficacy and the 1962 Amendments, 60 Geo. L.J. 185, 187 (1971). FDA did not accept New Drug Applications ( NDAs ) for drugs it considered to be GRAS. Thus, thousands of drugs entered the market as GRAS, either because the manufacturer concluded that they were GRAS or because the manufacturer obtained an opinion from FDA. See Peter Barton Hutt et al., Food and Drug Law: Cases and Materials 579-80 (3d ed. 2007). The 1962 amendments to the FDCA required drugs, unless grandfathered, to be both safe and effective. Drug Amendments of 1962, Pub. L. No. 87-781, 76 Stat. 780 (1962). Under amended section 201(p) of the FDCA, all drug products were considered new drugs required to be the subject of an NDA unless they were considered generally recognized as safe and effective ( GRAS/GRAE ) or met the criteria of one of two grandfather clauses. 102(a)(2), 76 Stat. at 781; 107(c), 76 Stat. at 788. 2 Under section 505 of the FDCA, new drugs were subject to the NDA approval process, which required the manufacturer to show, among other things, that the drug was safe as labeled and there existed substantial evidence that it was effective for its labeled uses. 102(b)-(d), 76 Stat. at 781-82. 2 Section 201(p) also defined a new drug to be a drug that was considered GRAS/GRAE but was not in use for a material extent or for a material time under such conditions. 21 U.S.C. 321(p)(2). - 4 -
After the 1962 amendments, FDA began the process of taking products off the market that it considered to be unapproved new drugs. In a series of decisions in 1973 addressing FDA s procedures for removing drugs from the market and withdrawing NDAs of drugs FDA deemed ineffective, the Supreme Court held that FDA had jurisdiction to decide in administrative proceedings whether drugs were considered new drugs under the FDCA. Weinberger v. Bentex Pharm., Inc., 412 U.S. 645, 651-54 (1973); Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 626-27 (1973); Ciba Corp. v. Weinberger, 412 U.S. 640, 643-44 (1973). The Court further concluded that the determination of whether a drug was GRAS/GRAE under the new drug definition was essentially the same as determining whether substantial evidence of efficacy existed to justify approval of an NDA. Bentex Pharm., Inc., 412 U.S. at 652-53; Hynson, Westcott & Dunning, Inc., 412 U.S. at 689-30. The result of these decisions was to make it very difficult for manufacturers to challenge FDA s determination that a drug was not GRAS/GRAE. 3 3 Numerous manufacturers have tried and failed. E.g., United States v. 50 Boxes More or Less, 909 F.2d 24, 28 (1st Cir. 1990); United States v. 225 Cartons... Fiorinal With Codeine No. 1 and Foiorinal with Codeine No. 2, 871 F.2d 409, 418-19 (3d Cir. 1989); United States v. Undetermined Quantities of a Drug, Anucort HC Suppositories, 857 F.2d 1464, 1464 (3d Cir. 1988); United States v. Atropine Sulfate 1.0 mg. (Article of Drug) Dey Dose, 843 F.2d 860, 861-64 (5th Cir. 1988); United States v. Articles of Drug... Promise Toothpaste for Sensitive Teeth, 826 F.2d 564, 572-73 (7th Cir. 1987); United States v. Articles of Drug... 5,906 Boxes, 745 F.2d 105, 117-19 (1st Cir. 1984); (...continued) - 5 -
By 1972, FDA concluded that it would be unrealistic to apply the 1962 amendments efficacy standard to OTC drugs on a case-by-case basis because there were between 100,000 and 500,000 OTC drug products on the market. Proposal Establishing Rule Making Procedures for Classification, 37 Fed. Reg. 85, 85 (proposed Jan. 5, 1972) (to be codified at 21 C.F.R. 130.301); see also Bentex Pharm., Inc., 412 U.S. at 650 (discussing the rationale for the monograph process). Thus, in May of 1972, FDA adopted the monograph process for determining whether particular OTC products not covered by NDAs are safe products, not ineffective, and not misbranded. Procedures for Classification of Over-the-Counter Drugs, 37 Fed. Reg. 9464, 9473 (May 11, 1972) (codified at 21 C.F.R. 130.301). The process involved the establishment of independent expert panels for different categories of OTC drugs (e.g., antacids, laxatives, analgesics) that would review all available data and prepare monographs prescribing drug composition and labeling. United States v. X Otag Plus Tablets, 602 F.2d 1387, 1391 (10th Cir. 1979); United States v. Mosinee Research Corp., 583 F.2d 930, 933 (7th Cir. 1978); United States v. 1,048,000 Capsules... Afrodex, 494 F.2d 1158, 1160-64 (5th Cir. 1974); Durovic v. Richardson, 479 F.2d 242, 250-51 (7th Cir. 1973); United States v. Vital Health Products, Ltd., 786 F. Supp. 761, 773-74 (E.D. Wisc. 1992); United States v. Seven Cardboard Cases... 100 Capsules NDC, ESGIC, with Codeine Capsules, 716 F. Supp. 1221, 1223-24 (E.D. Mo. 1989); United States v. 118/100 Tablet Bottles, 662 F. Supp. 511, 513-15 (W.D. La. 1987); United States v. Articles of Drug... Hormonin, 498 F. Supp. 424, 433-45 (D.N.J. 1980); United States v. Sene X Eleemosynary Corp., Inc., 479 F. Supp. 970, 977-78 (S.D. Fla. 1979); United States v. Articles of Drug... Colchicine, 442 F. Supp. 1236, 1243 (S.D.N.Y. 1978). - 6 -
FDA s procedures for its monograph process are now codified in 21 C.F.R. Part 330. This process begins by convening an advisory panel for each therapeutic class to review data relating to claims and active ingredients. These panel reports are then published in the Federal Register. 21 C.F.R. 330.10(a)(1)-(6). After review of the proposal, comments, and any new information submitted, FDA publishes tentative final monographs ( TFMs ) that set forth FDA s proposals for the allowable claims, labeling, dosages, and active ingredients for OTC drugs in the class. 21 C.F.R. 330.10(a)(7). The final step is the publication of a final monograph for each class. Id. 330.10(a)(9). Drugs marketed in accordance with a final monograph are considered to be GRAS/GRAE and do not require FDA approval of a marketing application. 21 C.F.R. 330.1, 330.10(a)(9); see also FDA, Compliance Policy Guide 440.110 app. (2011). REASONS FOR GRANTING THE WRIT I. The Monograph Process Sets Forth FDA s Determinations of the Conditions For Marketing OTC Monograph Products The central purpose of the monograph process is to set forth the conditions under which FDA considers an OTC product to be GRAS/GRAE and not misbranded. Accordingly, manufacturers of products subject to the monograph process cannot unilaterally modify their labeling such as changing the recommended dosing without facing a significant risk of enforcement. - 7 -
Final monographs represent FDA s determination that a drug is GRAS/GRAE and not misbranded, provided that the drug meets the monograph s requirements for claims, labeling, dosage, and active ingredients, among other requirements. 21 C.F.R. 330.1, 330.10(a)(9). On the issue of labeling, the monograph regulations are clear that the drug facts section which sets forth the dosage schedules and warnings at issue in this case must comply with labeling requirements set forth in the applicable monograph. Manufacturers are permitted to depart from the monograph labeling in only two narrow ways: they may use alternate language to describe indications, and they may substitute certain words with specific synonyms that FDA sets forth in its regulations. 21 C.F.R. 330.1(b)(2). The regulations do not permit the labeling of a product marketed under a final monograph to adopt dosing information or warnings that FDA does not expressly permit in the applicable monograph. See id. Accordingly, to adopt labeling inconsistent with the monograph, a manufacturer that markets a product under a final monograph would need to file an NDA seeking a deviation from the monograph under 21 C.F.R. 330.11 or petition the agency to change the monograph. Like many OTC products currently on the market, Petitioner s Infant Tylenol product was the subject of a TFM in this case, the internal analgesic, antipyretic, and antirheumatic ( IAAA ) TFM. Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-The-Counter Human Use; Tentative Final Monograph, 53 Fed. Reg. 46,204 (proposed Nov. 16, 1988) (to be codified - 8 -
at 21 C.F.R. Part 343). 4 As described above, the TFM is the penultimate step in finalization of a monograph, representing FDA s proposal for the conditions under which an OTC product will be considered GRAS/GRAE and not misbranded. 21 C.F.R. 330.10(a)(7); see also 53 Fed. Reg. at 46,204 ( [FDA] is issuing a notice of proposed rulemaking in the form of a [TFM] that would establish conditions under which over-the-counter (OTC) internal analgesic... products are generally recognized as safe and effective and not misbranded.... This proposal constitutes FDA s tentative adoption of the Internal Analgesic Panel s conclusions.... ). FDA has stated that it will not, as a general matter, take regulatory action against products covered by pending monograph proceedings. FDA, Compliance Policy Guide 440.110 app. (2011). FDA has, however, taken action against products subject to pending monographs when the agency deemed them to be public health risks. 5 Thus, 4 A number of TFMs, including the IAAA TFM, have been pending for decades. E.g., FDA, Rulemaking of OTC External Analgesic Drug Products, http://www.fda.gov/drugs/ DevelopmentApprovalProcess/DevelopmentResources/Over-the- CounterOTCDrugs/StatusofOTCRulemakings/ucm155846.htm (Dec. 15, 2009); FDA, Rulemaking History for OTC Topical Antimicrobial Drug Products, http://www.fda.gov/drugs/ DevelopmentApprovalProcess/DevelopmentResources/Over-the- CounterOTCDrugs/StatusofOTCRulemakings/ucm070821.htm (Dec. 14, 2009). Accordingly, a significant share of OTC products currently on the market are subject to TFMs, rather than final monographs. 5 E.g., Certain Halogenated Salicylanides as Active or Inactive Ingredients in Drug and Cosmetic Products, 40 Fed. Reg. 50,527, 50,527-30 (Oct. 30, 1975) (codified at 21 C.F.R. (...continued) - 9 -
manufacturers of products subject to ongoing monograph proceedings must ensure that their products are formulated and labeled in manner that FDA would consider GRAS/GRAE. TFMs, like the IAAA TFM, serve as guidance for industry as to the conditions FDA currently believes are necessary for a drug product to be considered GRAS/GRAE. See 21 C.F.R. 10.85(d)(1), (e), (f) (explaining that a statement of policy made in any portion of a Federal Register notice other than the text of a proposed or final regulation is considered an advisory opinion that is the formal position of FDA on a matter that except in instances of immediate and significant danger to health obligates the agency to follow it until it is amended or revoked ). In other words, a manufacturer that markets an OTC product subject to a TFM would be at very little risk of its product being considered a new drug subject to enforcement if the product complies with the conditions of the TFM, including labeling requirements. In contrast, a manufacturer faces a significant risk by materially departing from the conditions of a TFM. FDA has issued numerous warning letters 310.508); Aerosol Drug and Cosmetic Products Containing Zirconium, 42 Fed. Reg. 41,374, 41,376 (Aug. 16, 1977) (codified at 21 C.F.R. 310.510); see also FDA, Compliance Policy Guide 450.200 (1995) ( Samples of OTC drugs, not subject to a final monograph should not be submitted for regulatory action consideration on the basis of suspected labeling deficiencies unless there is a reasonable basis to conclude that the deficiency constitutes a potential hazard to health. ). - 10 -
illustrating this point. 6 As explained above, this Court s decisions have made it very difficult for a manufacturer to establish that a product is not a new 6 For example, FDA has noted in warning letters to manufacturers that [p]ending a final monograph, the agency does not object to the marketing of OTC drugs that meet the formulation and labeling requirements described in the relevant TFM. Letter from Teresa C. Thompson, District Director, Cincinnati Division, to Donald Nelson, President and CEO, JD Nelson and Associates, LLC (April 18, 2011). See, e.g., Letter from LaTonya M. Mitchell, Denver District Director, to Boyd Ronald Johnson, CEO, Quadex Pharmaceuticals, LLC, (May 7, 2012) (objecting to the labeling of a cold sore product that purported to be effective for treating herpes because FDA stated in the cold sore TFM that the term herpes, when used alone, is misleading for cold sore products); Letter from Michael M. Levy, Jr., Esq., Director, Division of New Drugs and Labeling Compliance, to Roger D. Griggs, Chairman, Union Spring Pharmaceuticals, LLC (May 23, 2011) ( Pending a final monograph, the agency does not object to the marketing of OTC drugs that meet the formulation and labeling requirements described in the tentative final monograph. ); Letter from Emma R. Singleton et al., to Stacy Lyles, Medavir Medical Advances, Inc. (Apr. 28, 2011) (objecting to the labeling of a cold sore product that purported to be effective for treating herpes because FDA stated in the cold sore TFM that the term herpes, when used alone, is misleading for cold sore products); Letter from Charles M. Breen, District Director, to Steve D. Smith, President, Tec Laboratories, Inc. (Apr. 18, 2011) ( Pending a final monograph, the agency does not object to the marketing of OTC drugs that meet the formulation and labeling requirements described in the TFMs. ); Letter from Richard L. Friedman, Director, Division of Manufacturing and Product Quality, Office of Compliance, to Goh Bee Leong, General Manager, Haw Par Healthcare Limited (July 20, 2010) (alleging that the manufacturer s Tiger Balm drug product was misbranded because it purported to penetrate and stimulate blood at the application site, which differed from the uses described in the external analgesic TFM). - 11 -
drug. 7 And manufacturers are subject to criminal prosecution for distributing an unapproved new drug in interstate commerce. 21 U.S.C. 331(d); 21 U.S.C. 333(a). Thus, no prudent manufacturer would materially depart from the labeling requirements of the TFM for example, by making a change to the recommended dosing without first seeking FDA s approval. In this case, Petitioner sought FDA s approval to implement a material labeling change when it filed a Citizen Petition in 1999 requesting that FDA amend the TFM to permit dosing for infants. 8 II. Under the Court s Decision in PLIVA, Inc. v. Mensing, Failure to Warn Claims Regarding the Labeling of OTC Monograph Drugs are Preempted Because Manufacturers Cannot Unilaterally Change Their Labels Because manufacturers of OTC drugs subject to the monograph process cannot unilaterally change 7 See Hyson, Westcott & Dunning, Inc., 412 U.S. at 632 ( [A] drug can be generally recognized by experts as effective for intended use within the meaning of the Act only when that expert consensus is founded upon substantial evidence as defined in 505(d). ); Bentex Pharm., Inc., 412 U.S. at 653 ( [T]he reach of scientific inquiry under both 505(d) and 201(p) is precisely the same. ); cases cited supra note 3. 8 See McNeil Consumer Healthcare, Citizen Petition to Amend the Tentative Final Monograph for Internal Analgestic [sic], Antipyretic and Antirheumatic Drug Products for Over-the- Counter Use - Expanded Age Groups for OTC Consumer Dosing Instructions covering Acetaminophen, Docket No. 77N-0094 (Feb. 1, 1999). FDA has not amended the TFM to allow labeling recommending dosages for infants. - 12 -
their labels, this Court s preemption jurisprudence requires that state-law claims regarding the sufficiency of labeling be preempted. The Louisiana Court of Appeals clearly misread this Court s decisions in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) and Wyeth v. Levine, 129 S. Ct. 1187 (2009). The Court of Appeals erroneously concluded that preemption does not apply to claims against a brand-name manufacturer. The issue, instead, is whether the manufacturer could unilaterally implement changes to the label. Petitioner could not have done so without incurring significant risk of FDA enforcement. In Wyeth and PLIVA, this Court delineated a test for conflict preemption that hinges on whether the private party could independently do under federal law what state law requires of it. PLIVA, 131 S. Ct. at 2579. The brand-name manufacturer of prescription drugs in Wyeth was able to use the changes being effected ( CBE ) process to alter its labeling in particular ways without FDA s prior approval. See 21 C.F.R. 314.70(c)(6)(iii) (codifying the CBE process); Wyeth, 129 S. Ct. at 1196-97. Without clear evidence that FDA would not have approved such an alteration, claims against the manufacturer were not preempted. Wyeth, 129 S. Ct. at 1198. In contrast, under [f]ederal drug regulations, as interpreted by the FDA, PLIVA, 131 S. Ct. at 2577, a generic manufacturer of prescription drugs may not use the CBE process to alter the drug s label because FDA requires the generic drug label to be - 13 -
identical to that of the brand-name drug; approval may be withdrawn if the generic drug s label is no longer consistent with that for [the brand-name]. Id. at 2575 (quoting 21 C.F.R. 314.150(b)(10) (alteration in original)). Instead, the manufacturer must ask FDA to work with the brand-name manufacturer to institute a label change and it is merely possible that FDA will grant that request. Id. at 2579. The Court therefore determined that a generic manufacturer cannot act sufficiently independently under federal law to do what state law requires : change its label to incorporate additional safety information. See id. at 2580. State law failure-to-warn claims against these manufacturers were thus preempted. As described above, manufacturers of monograph OTC drugs, like Petitioner, are not governed by the labeling regulations as set forth in either Wyeth or PLIVA. A decision as to whether failure-to-warn claims against them are preempted therefore must involve a distinct analysis of whether, given FDA s interpretation of the monograph regulatory framework, a manufacturer may act sufficiently independently to meet the requirements of state law. The Louisiana Court of Appeal s analysis was wholly deficient in this regard. It merely stated that PLIVA dealt with state law claims against manufacturers of generic drugs, not a brand-name manufacturer like McNeil and therefore was irrelevant. Pet. App. 20a. The court then concluded that, as Petitioner did not attempt to include all of Respondents desired warnings on the drug label, it had failed to establish conflict preemption. See id. The court made no attempt to determine whether - 14 -
Petitioner could have instituted those warnings without facing FDA enforcement action. The monograph process prevents an OTC drug manufacturer from deviating from the requirements of the monograph without substantial risk of FDA taking enforcement action against the manufacturer. For final monographs, the regulations flatly prohibit a manufacturer from deviating from each of the conditions contained in any applicable monograph lest the product be liable to regulatory action. 21 C.F.R. 330.1. There is no method by which a manufacturer may independently surmount this restriction; the only options to achieve a label change are filing an NDA or petitioning for a change to the monograph. Both of those options require FDA to exercise its independent judgment. Thus, the manufacturer cannot act without the Federal Government s special permission and assistance. PLIVA, 131 S. Ct. at 2581. PLIVA therefore requires that failure-to-warn claims involving the labels of OTC drugs governed by a monograph be preempted. Even if there is no final monograph in place, manufacturers face a significant risk of enforcement action if they do not comply with the applicable TFM for material portions of the label, such as the dosing recommendations. The TFMs represent FDA s proposal for the conditions under which certain OTC drugs are considered GRAS/GRAE. Given the challenges a manufacturer faces under Bentex and Hynson in demonstrating that a drug is GRAS/GRAE, no prudent manufacturer would materially depart from the conditions specified in a TFM without first asking FDA for permission. As - 15 -
demonstrated by its warning letters, see supra n.6, FDA has taken enforcement action against OTC drugs on the ground that they deviate from key standards set forth in a TFM. Thus, just as the generic manufacturer in PLIVA was not expressly prohibited from using the CBE process but would have become vulnerable to FDA enforcement action had it done so, an OTC manufacturer is not expressly required by the regulations to conform to a TFM but runs significant risk of enforcement action if it does not do so in all material respects. Because an OTC drug manufacturer that markets products subject to a TFM lacks the ability to independently modify its label in material respects, it is impossible under the standard set forth in Wyeth and PLIVA for the manufacturer to satisfy its state law duties. As such, failure-to-warn claims against manufacturers of all OTC drugs subject to the monograph process should be deemed preempted by federal law. - 16 -
CONCLUSION The Court should grant the petition for a writ of certiorari. The Court may wish to consider summary reversal. Respectfully submitted, ROBERT A. LONG, JR.* GERALD F. MASOUDI CHRISTOPHER H. PRUITT EMILY S. ULLMAN COVINGTON & BURLING LLP 1201 Pennsylvania Ave, N.W. Washington, DC 20004 (202) 662-6000 August 27, 2012 *Counsel of Record - 17 -