MARIE BOYD
I. INTRODUCTION
The potential legal remedies available to a person injured by a generic drug differ from those available to a person injured by the corresponding brand-name drug. In Wyeth v. Levine, the U.S. Supreme Court held that federal law does not preempt state failure-to-warn claims against the manufacturer of a brand-name drug (Wyeth v. Levine, 2009:581). In PLIVA, Inc. v. Mensing, it held that federal law does preempt such claims against the manufacturer of a generic drug (PLIVA, Inc. v. Mensing 2011:2581). This result is due to differences in how brand-name and generic drugs are regulated under federal law (ibid., 2582).
By holding that state failure-to-warn claims against generic drug manufacturers are preempted, the Court eliminated the protections that state tort law can provide consumers of generic drugs through the law’s compensation and information disclosure functions (Rabin 2007:301; Kessler and Vladeck 2008:483). It also exposed a gap in the federal regulation of generic drug labeling in which no manufacturer is responsible for updating the labeling of generic drugs if the corresponding brand-name drug is no longer marketed (PLIVA, Inc. v. Mensing 2011:2592–93; Sotomayor, J., dissenting; Lee 2012:239–41).1 The preemption of failure-to-warn claims against generic drug manufacturers could have widespread effect as generic drugs account for approximately 80 percent of the prescriptions dispensed in the United States (Dicken 2012:2, 9; IMS Inst. for Healthcare Informatics 2012:26), and approximately 23 to 32 percent of drugs are available solely as generics (Brief for Marc T. Law et al. 2011:18). There are approximately 106,000 deaths per year from “nonerror, adverse effects of medications,” and the actual magnitude of adverse drug effects is likely greater because that estimate does “not include adverse effects that are associated with disability or discomfort” (Starfield 2000:484).
In apparent recognition of the gravity of these issues, the U.S. Food and Drug Administration (FDA) published a notice of proposed rulemaking (NPRM), which if finalized would permit generic drug manufacturers to update their product labeling in certain circumstances (FDA’s proposed rule) (Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, 78 Fed. Reg. 67,985 (Nov. 13, 2013)). This chapter argues that rather than proceed with the informal, notice-and-comment rulemaking procedure, FDA should use negotiated rulemaking to work with stakeholders to address the issues raised and exposed by Mensing, build consensus, and amend the regulations. Negotiated rulemaking may foster the development of a more effective, enforceable, and legitimate rule as compared to informal rulemaking.
II. PREEMPTION AND THE REGULATION OF DRUGS
Both Wyeth and Mensing involved patient injuries that followed the administration of a prescription drug and allegations that the drug’s manufacturer failed to adequately warn the plaintiff of the risk of the injuries suffered. In Wyeth, a brand-name drug was administered, whereas in Mensing, a generic drug was administered, and the preemption results differed because the regulations for generic drugs are “meaningfully different” from those for brand-name drugs (PLIVA, Inc. v. Mensing 2011:2582).
A. Wyeth v. Levine and the Regulation of Brand-Name Drugs
In Wyeth, the Court held that federal law did not preempt a plaintiff’s state-law claim that brand-name drug labeling did not contain an adequate warning (Wyeth v. Levine 2009:564−65, 581). According to the Court, Wyeth could have unilaterally strengthened its warning under FDA’s “changes-being-effected” (CBE) regulation, which permits manufacturers to make certain changes (including “[t]o add or strengthen…a warning”) to the FDA-approved labeling of a drug when FDA receives a CBE supplement from the manufacturer (Wyeth v. Levine 2009:571, 573; 21 CFR § 314.70(c)(6)(iii) (2014); FDA 2004:3–4, 24–26). Thus, it was not impossible for Wyeth to comply with both the federal requirements—the Federal Food, Drug, and Cosmetic Act (FDCA) and FDA’s regulations, which Wyeth argued required it to keep the drug labeling the same as that in its approved new drug application (NDA)—and the state requirements, which Wyeth argued required it to change the drug’s labeling (Wyeth v. Levine 2009:571, 573; Brief for Petitioner 2009:33–34; Reply Brief for Petitioner 2009:1–4). The Court also held that the failure-to-warn claims did not obstruct the “purposes and objectives” of the federal regulatory scheme (Wyeth v. Levine 2009:581). The Court stated that “it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times” (ibid., 570–71, 581).
B. PLIVA, Inc. v. Mensing and the Regulation of Generic Drugs
Approximately two years after Wyeth, the Court in Mensing considered whether similar state failure-to-warn claims against the manufacturers of generic drugs were preempted (PLIVA, Inc. v. Mensing 2011:2572–73). The Court held that they were because it was “impossible” for the manufacturers to independently comply with both their federal law duty that the labeling of their generic drug products be the same as the corresponding brand-name drug labeling and their state-law duty to change the labeling to strengthen their warnings (ibid., 2578).
The Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”) created an abbreviated approval process for generic drugs—the abbreviated new drug application (ANDA) process, in which generic drugs are approved on the basis of information showing that they are bioequivalent to a reference listed drug (RLD), generally a brand-name drug (21 USC § 355(j)(2)(A)(iv), (j)(4)(F), (j)(7) (2012); FDA Orange Book). FDA’s regulations define RLD as “the listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its abbreviated application” (21 CFR § 314.3 (2014)). The statute and regulations provide that a generic drug manufacturer must show, among other things, that the proposed generic drug labeling “is the same as” the RLD’s approved labeling (21 USC § 355(j)(2)(A), (j)(4) (2012); 21 CFR §§ 314.94(a)(8)(iii), 314.127(a)(7) (2014)).2 The regulations also add that FDA may act to withdraw an approved ANDA if the product’s labeling “is no longer consistent with that” of the RLD (21 CFR § 314.150(b)(10) (2014)).
The Mensing Court deferred to FDA’s interpretation of the regulations as requiring that the generic manufacturers’ labeling “always be the same” as that of the brand-name drug and as precluding generic manufacturers from unilaterally strengthening their generic drug’s warnings using the CBE process or sending “Dear Doctor” Letters (PLIVA, Inc. v. Mensing 2011:2575–76; Brief for the United States as Amicus Curiae Supporting Respondents 2011:14–19). FDA interpreted its regulations as permitting generic manufacturers to use the CBE process to change the labeling of a generic drug only when the change is to match the corresponding brand-name drug’s labeling or to follow FDA’s instructions (PLIVA, Inc. v. Mensing 2011:2575–76; Brief for the United States as Amicus Curiae Supporting Respondents 2011:15, 16 nn7−8).
III. FDA’S PROPOSAL TO REFORM THE REGULATION OF GENERIC DRUGS
In November 2013, FDA issued an NPRM that would amend FDA’s current labeling regulations to create a modified CBE process that would permit generic manufacturers to independently make certain labeling changes at the time a CBE supplement is received by FDA (Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, 78 Fed. Reg. 67,985, 67,989 (Nov. 13, 2013)). The proposal contained procedures that would make submitted changes publicly available during FDA’s review and alert the manufacturer of the corresponding brand-name drug, if any, of the supplement (ibid., 67,990). The manufacturers of other versions of the generic drug and the corresponding brand-name drug would be permitted to submit CBE supplements and comment on a submitted supplement (ibid., 67,991–92). If FDA approved a labeling change, it would do so “for the generic drug and the corresponding brand drug at the same time, so that…[these] products [would] have the same FDA-approved labeling” (Howard 2014:2). Within thirty days of the approval, manufacturers of other versions of the generic drug would be required to submit CBE supplements with conforming labeling changes (Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, 78 Fed. Reg. 67,985, 67,993, 67,999 (Nov. 13, 2013)). When this chapter was written, FDA’s proposed rule had not been finalized.3
While FDA’s proposal was a step toward addressing the issues raised and highlighted by Mensing, rather than proceed with the conventional informal rulemaking process, FDA should utilize negotiated rulemaking.
IV. NEGOTIATED RULEMAKING
In 1982, the Administrative Conference of the United States recommended procedures for negotiating proposed regulations and urged Congress to pass legislation authorizing agencies to conduct regulatory negotiation (Recommendations of the Administrative Conference, 47 Fed. Reg. 30,701, 30,709 (July 15, 1982)). It based its recommendation on a report by Philip Harter (Harter 1982:1). Harter also authored an article on negotiated rulemaking as an alternative to the notice-and-comment rulemaking set forth by section 553 of the Administrative Procedure Act (APA), which he argued had become mired in a “malaise” (ibid., 5–6, 28).
Harter identified several factors that may help guide the determination of whether negotiations are appropriate (ibid., 42–52): The parties must believe that participation is in their best interests and no party should have the power to impose its will on the others; the number of parties should be limited; the issues to be resolved concrete and ready for resolution; a decision inevitable or even imminent; the dispute capable of being “transformed into a ‘win/win’ situation” for the parties; the parties able to agree on fundamental principles; the number of issues sufficient to permit trade-offs; the “[r]esearch [n]ot [d]eterminative of [the o]utcome”; and the implementation of the negotiated agreement likely (ibid., 45–52). Harter emphasized the importance of identifying the interests that should be represented in the negotiations, identifying appropriate representatives of such interests, and obtaining their participation (ibid., 52–57).
The Negotiated Rulemaking Act of 1990 (NRA) created a framework for using a “negotiated rulemaking committee…to consider and discuss issues for the purpose of reaching a consensus in the development of a proposed rule” and “encourage[s] agencies to use [negotiated rulemaking] when it enhances the informal rulemaking process” (5 USC § 562(6), (7) (2012); Negotiated Rulemaking Act 1990). Before an agency can establish a negotiated rulemaking committee, it must consider whether (1) the rule is needed; (2) “there are a limited number of identifiable interests that will be significantly affected by the rule”; (3) it is reasonably likely “that a committee can be convened with a balanced representation of persons who…can adequately represent the [identified] interests…and…are willing to negotiate in good faith to reach a consensus on the proposed rule”; (4) it is reasonably likely that a committee will reach such a consensus “within a fixed period of time”; (5) the “procedure will not unreasonably delay the notice of proposed rulemaking and the issuance of the final rule”; (6) “the agency has adequate resources…[that it] is willing to commit…to the committee”; and (7) “the agency, to the maximum extent possible consistent with [its] legal obligations…, will use the consensus of the committee with respect to the proposed rule as the basis for the rule proposed by the agency for notice and comment” (5 USC § 563 (2012)).
If the agency determines that negotiated rulemaking “is in the public interest” and decides to establish a negotiated rulemaking committee, it must publish a notice in the Federal Register announcing its intention to do so and provide a period for the submission of comments and committee membership applications (5 USC § 564 (2012)). The agency may establish a negotiated rulemaking committee if it determines that such a committee “can adequately represent the interests that will be significantly affected by a proposed rule and that it is feasible and appropriate in the particular rulemaking” (5 USC § 565 (2012)). The committee, including the agency representatives, must negotiate to attempt to reach a consensus on a proposed rule (5 USC § 566(a) (2012)): If the committee reaches a consensus on a proposed rule, it must provide the agency with a report and the proposal; if it does not, it may provide a report on any areas of consensus (5 USC § 566(f) (2012)). A rule based on the committee’s consensus that is proposed by an agency is subject to the APA’s informal rulemaking requirements (5 USC § 561 (2012); Pritzker and Dalton 1995:1, 2).
Although used infrequently (Coglianese 1997:1276, 1277 table 2; Lubbers 2008:1007–17), negotiated rulemaking has been the subject of ongoing debate. There is substantial academic literature supporting negotiated rulemaking (Funk 1997:1353); however, negotiated rulemaking is not without critics (Coglianese 1997:1316–17; Funk 1997:1356; Funk 1987:66–78, 92–96; Rose-Ackerman 1994:1211). Commentators have divided over questions of the legitimacy, benefits, and effectiveness of negotiated rulemaking. Supporters have argued that it may further legitimacy and accountability, “improve relationships among repeat players,” and create better and more widely accepted rules (Freeman 2000:548–49, 656–57, 666; Freeman 1997:30–33; Freeman and Langbein 2000; Harter 2000:52–54; Harter 1982:22, 31, 69, 84, 94; Susskind and McMahon 1985:133). Critics have countered that it lacks legitimacy, undermines the public interest with private bargaining, and has not been successful in decreasing rulemaking time and judicial challenges to rules (Funk 1987:57; Rose-Ackerman 1994:1208–12; Coglianese 1997:1335–36).
To date, FDA has not convened a negotiated rulemaking committee or been required by Congress to do so.4 Nevertheless, FDA expressed openness to considering the use of negotiated rulemaking in one of its food labeling regulations, which requires certain petitions to include a statement on the feasibility of using negotiated rulemaking (21 CFR § 101.12(h) (2014)). Also, it has been reported that FDA has considered using negotiated rulemaking in other contexts (FDA Waiver of User Fees 1994; OTC Label Reform 1995; Device Software Policy Revisions 1996).
V. THE CASE FOR NEGOTIATED RULEMAKING
The issues raised and highlighted by the Mensing decision appear well suited to negotiation, and the use of negotiated rulemaking may further the public interest. Although FDA has already promulgated an NPRM, it is not too late for FDA to employ negotiated rulemaking, as nothing in the NRA prohibits an agency from using negotiated rulemaking after an NPRM so long as the requirements of the NRA are met (5 USC §§ 561–70a (2012)). The Administrative Conference specifically recognized that “negotiating the terms of a final rule could be a useful procedure even after publication of a proposed rule” (1 CFR § 305.85-5(3) (1986)), and several agencies have created negotiated rulemaking committees after publication of an interim or proposed rule (Vehicles Built in Two or More Stages, 64 Fed. Reg. 27,499 (May 20, 1999); Paleontology; Negotiated Rulemaking, 54 Fed. Reg. 48,647 (November 24, 1989); Varroa Mite Regulations, 54 Fed. Reg. 15,217 (Apr. 17, 1989)).
A. The Need for a Rule
There is a need for new drug labeling regulations. By finding that state failure-to-warn claims against the manufacturers of generic drugs are preempted under FDA’s current regulatory regime, the Mensing Court removed the protections that state tort law can provide to consumers. As discussed earlier, that decision also highlighted a gap in the regulation of generic drug labeling where no manufacturer may be responsible for updating a drug’s labeling. This is concerning given that “[m]any serious [adverse drug reactions] are discovered only after a drug has been on the market for years” (Lasser et al. 2002:2218) and FDA “faces significant resource constraints that limit its ability to protect the public from dangerous drugs” (Mutual Pharmaceutical Co. v. Bartlett 2013:2485; Sotomayor, J. dissenting). Furthermore, the different potential remedies for injured consumers of generic versus brand-name drugs are inconsistent with FDA’s policy of promoting the “sameness” of these products (PLIVA, Inc. v. Mensing, 2011:2593; Sotomayor, J., dissenting).
The Court in Mensing noted that FDA retains the authority to change its regulations if it so desires (ibid., 2582), and in apparent recognition of the need for regulatory change, FDA has proposed new regulations using the informal rulemaking process (Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, 78 Fed. Reg. 67,985 (Nov. 13, 2013)).
B. The Issues Are Concrete, Ready for Decision, and Sufficient to Permit Trade-Offs
The issues for consideration are concrete and ready for decision;5 issues related to the regulation of drug labeling were considered in several opinions (Mutual Pharmaceutical Co., Inc. v. Bartlett 2013:2476–77; PLIVA, Inc. v. Mensing 2011:2574−77; Wyeth v. Levine 2009:568–73; Mutual Pharmaceutical Co., Inc. v. Bartlett 2013:2480, Breyer, J., dissenting; Mutual Pharmaceutical Co., Inc. v. Bartlett 2013:2483, Sotomayor, J., dissenting; PLIVA, Inc. v. Mensing 2011:2582, Sotomayor, J., dissenting), briefs (Brief for Marc T. Law et al. 2011; Brief for the United States as Amicus Curiae Supporting Respondents 2011; Brief for the United States as Amicus Curiae 2011), proposed legislation (Patient Safety and Generic Labeling Improvement Act, S. 2295 2012; Patient Safety and Generic Labeling Improvement Act, H.R. 4384 2012), FDA’s proposed rule (Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, 78 Fed. Reg. 67,985, 67,989 (Nov. 13, 2013)), a Citizen Petition (Public Citizen 2011:9–10) and FDA’s response to that petition (FDA Response to Public Citizen 2013:2), and a growing body of academic literature including proposals for legislative or regulatory change (Lee 2012:252–54; Duncan 2010:209–10; Kazhdan 2012:919; Stoddart 2012:1993−96; Weeks 2012:1259, 1289). The existing proposals suggest that in addition to the issues noted earlier, any proposal should consider and address: (1) who should be able to make labeling changes and under what circumstances; (2) how to encourage appropriate and timely warnings; (3) whether and how to reconcile differences between the labeling of different versions of a drug after a labeling change; and (4) whether there is a need for increased information sharing, reporting, or producing in order for manufacturers to fulfill any new regulatory responsibilities (Boyd 2014; discussing proposals). While FDA’s regulation of drug labeling is likely to be central to any rulemaking, the existence of multiple potential issues and differences in the participants’ values may permit trade-offs among the parties to maximize their interests (Harter 1982:50; Susskind and McMahon 1985:152).6 The parties’ interests may include the shared value of consumer access to safe and effective drugs,7 and this value may serve as the foundation for regulatory negotiation (Harter 1982:49).
C. Interests Likely to Be Impacted and Representation
There appears to be a limited number of identifiable interests that would be significantly affected by a rule to address the issues implicated by the Mensing decision. Pursuant to the NRA, an “interest” is “multiple parties which have a similar point of view or which are likely to be affected in a similar manner” with respect to an issue (5 USC § 562(5) (2012)). So, for example, all generic drug companies that must comply with new regulations may be affected by a change in generic drug labeling regulation. Many of these companies may be affected in a similar manner and represent one interest, which should be represented on the negotiated rulemaking committee.
Brand-name drug manufacturers, consumers, and health care providers may also be significantly impacted by a new rule and should be represented. For example, regulatory change may impact brand-name manufacturers by requiring them to update their labeling following generic drug labeling updates or to provide information to facilitate labeling updates. It may impact consumers by affecting the safety and efficacy of generic drugs and the potential remedies available to consumers injured by such drugs. It may also impact health care providers who are licensed to administer prescription drugs and who utilize drug labeling to make prescription decisions (21 USC §§ 352(f)(1), 353(b)(1)–(2) (2012); 21 CFR § 201.5 (2014); Brief of the AMA et al. 2011:29, 30). Other potential interests that may be impacted by a new rule include states, biologic manufacturers, and pharmacists. The negotiated rulemaking committee must include at least one FDA representative (5 USC § 565(b) (2012)). This discussion suggests that the “number of identifiable interests that will be significantly affected by the rule” (and thus, the number of committee members needed to represent such interests) is limited and appears likely to be less than the twenty-five-member limit generally provided by the NRA (5 USC §§ 563(a)(2), 565(b) (2012)).
It seems reasonably likely that FDA could convene a negotiated rulemaking committee with a balanced representation of persons who (1) can “adequately represent” the interests identified as “significantly affected by the rule”; and (2) “are willing to negotiate in good faith to reach a consensus on the proposed rule” (5 USC §§ 563, 565 (2012)). For example, trade associations may be able to represent the interests of brand-name and generic drug manufacturers, and consumer and professional organizations may be able to represent the consumer and health care providers’ interests. FDA may be able to draw on its experience in convening advisory committees to facilitate this process (FDA Draft Guidance 2008:3; 21 CFR §§ 14.1–14.174 (2014); FDA Advisory Committees 2011; Sherman 2004:99–102).
D. Potential Gains
There are several reasons why the significantly affected interests may be “willing to negotiate in good faith to reach a consensus on the proposed rule” (5 USC § 563(a)(3)(B) (2012)) and believe that negotiated rulemaking would be for their benefit.
First, FDA has proposed a rule that would revise the procedures for changes to the labeling of an approved drug, suggesting that a new rule is inevitable, if not imminent (Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, 78 Fed. Reg. 67,985 (Nov. 13, 2013)). This may create a sense of urgency on the part of the participants in the proposed negotiated rulemaking and speed up negotiations (Harter 1982:47–48). These participants may view the proposed negotiated rulemaking as a beneficial opportunity for meaningful participation in and some control over the creation of a new regulatory system for drugs, which may further encourage negotiation (Freeman and Langbein 2000:62–69). Participants would be deprived of this opportunity if negotiations failed and FDA continued with informal rulemaking (Freeman and Langbein 2000:67, 81, 84, 124). Second, the fact that the drug industry is a “highly regulated industry, in which all the players—including the agency, the drug companies, and even the representatives of consumers —are repeat players” (Rakoff 2000:169–70) may encourage the participants to negotiate in good faith, as they are likely to have future interactions. Third, although the current regulatory system’s impact on the various interests is highly complex (and empirical evidence would be needed to make any definitive statements about its impact), certain aspects of the current system may harm each of the interests, which may further encourage negotiation. For example, the current system may harm the market for generic drugs, encourage innovator liability suits against brand-name manufacturers (Rostron 2011:1123, 1135), present an “ethical dilemma” for doctors (Brief of the AMA et al. 2011:29−30), and have negative impacts on consumers.
E. Countervailing Power
A balance of power is one of the criteria that Harter identified as predictive of successful negotiations (Harter 1982:45). Power appears to be divided among the interests in the proposed negotiation. For example, the importance to the public health of the drugs that brand-name and generic drug manufacturers produce and the extent and characteristics of those markets (Snyder 2012:4−5; Snyder 2012a:4−5); FDA’s broad “authority to promulgate regulations for the efficient enforcement” of the FDCA and its ability to proceed with informal rulemaking if no consensus is reached (21 USC § 371(a) (2012)); health care providers’ roles as prescribers and learned intermediaries (21 USC § 353 (2012); Noah 2009:890); and consumers’ ability to request drugs and make purchasing choices (Campbell et al. 2013:237, 238) suggest that each of these interests has significant power. The use of negotiated rulemaking may be appropriate even if the parties’ power were unequal because the process may empower and constrain each of the parties as no party may “want to appear responsible for” a failure to reach consensus (Susskind and McMahon 1985:154−55).8
F. Potential Benefits
Using negotiated rulemaking to create new drug regulations may be in the public interest (5 USC § 563 (2012)). First, while FDA has not used negotiated rulemaking and the discussions of this process have been based on the experiences of other agencies (Coglianese 1997:1273), empirical data and commentators suggest that negotiated rulemaking may be “faster than traditional rulemaking” (Harter 2000:49) and may save time (Freeman and Langbein 2000:75). But even if negotiated rulemaking is not faster, it may hold other benefits (Harter 1982:28−31).
By engaging persons who can adequately represent the interests that will be significantly affected by new drug labeling rules, negotiated rulemaking may produce “better rules” (ibid., 115) and result in a process that functions better than the existing process (Harter 1997:1402−4; Freeman and Langbein 2000:66−67; Langbein and Kerwin 2000:605−8). For example, the current regulatory procedure for labeling updates (under which a manufacturer must update its generic drug labeling to match that of the corresponding brand-name drug following an update to the brand-name labeling) may not be functioning optimally; this may result in differences between the labeling of the brand-name and generic versions of a drug (Duke et al. 2013:299−300). While the impact of these differences on patient safety is not known, there may need to be “changes in the labeling cascade…to ensure ongoing synchronization of drug safety warnings” (ibid., 300). The existing labeling regime was created by FDA regulations promulgated through notice-and-comment rulemaking (57 Fed. Reg. 17,950 (Apr. 28, 1992); 50 Fed. Reg. 7,452, 7,466–70, 7,498–99 (Feb. 22, 1985)) and supplemented by the agency’s interpretations in preambles, briefs, and guidance. Using negotiated rulemaking to create new drug labeling and postmarket safety rules may increase the legitimacy of FDA’s final regulations (Freeman and Langbein 2000:124−27; Harter 1997:1403–4, 1407; Harter 1983:480, 489; Langbein and Kerwin 2000:625) and may lead to better relationships among the participants, who are likely to be repeat players in the world of drug regulation (Freeman 2000:656–57; Rakoff 2000:169–70). The perceived legitimacy of the final rule and the interactions among participants in the rulemaking may be significant because, while promulgation of a new final rule is an important first step in reform, once a new rule on drug labeling and postmarket safety goes into effect, the success of any new regulatory regime will depend on the participation of FDA and the stakeholders.
G. Response to Anticipated Criticisms
Despite the potential benefits of negotiated rulemaking, there may be critiques of the proposal that FDA use negotiated rulemaking to address the issues flowing from the Mensing decision. First, critics may argue that FDA does not need to use negotiated rulemaking because it already provides for public participation through its use of advisory committees and public meetings (21 CFR §§ 10.65, 14.1–174 (2014); DHHS and FDA 2013; Kobick 2010:439–40). Specifically, critics may argue that negotiated rulemaking is unnecessary because FDA has scheduled a public meeting on its proposed rule and alternatives (Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Public Meeting; Request for Comments; Reopening of the Comment Period, 80 Fed. Reg. 8577 (Feb. 18, 2015)).
These critiques, however, do not account for the important ways in which negotiated rulemaking would differ from FDA’s general use of advisory committees and public meetings. Unlike those other processes, negotiated rulemaking focuses on negotiation to generate consensus among stakeholders for use as the basis for a proposed rule. Indeed, many of the potential benefits of negotiated rulemaking discussed in Part V.F may flow from the negotiation and consensus building that characterize the process—benefits that other advisory committee processes or public meetings may not produce. For example, a negotiated rulemaking committee’s purpose would be to produce a consensus among stakeholders concerning a proposed rule and not simply to “provide advice and recommendations to the [FDA] Commissioner” (21 CFR § 14.5(a) (2014)) or “to listen to comments” (Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Public Meeting; Request for Comments; Reopening of the Comment Period, 80 Fed. Reg. 8577 (Feb. 18, 2015)). Furthermore, the agency’s commitment to use the consensus of the committee as the basis for a proposed rule, “to the maximum extent possible consistent with the legal obligations of the agency” (5 USC § 563(a) (2012)), is an “essential ingredient of the success” of the process (Harter 1982:100).
Second, critics may argue that negotiated rulemaking could cost both FDA and participants more than conventional informal rulemaking (Kobick 2010:438–39; Lubbers 2008:997–98). Negotiated rulemaking, however, may save costs because the negotiated rulemaking committee members may bring to the table important information that FDA would otherwise have to speculate about or invest resources in locating or developing (Freeman 2000:641). Negotiated rulemaking may save FDA and stakeholders costs at the end (i.e., through fewer comments and court challenges) (Lubbers 2008:997; Harter 2000:56). It may also save costs in the implementation of, compliance with, and enforcement of a new rule by creating a more effective rule (Harter 1997:1403–4; Merrill 1999:1180 n.137).9
A third anticipated criticism is that negotiated rulemaking may create rules that are no less subject to litigation than conventional rules (Coglianese 1997:1286–1309; Harter 2000:55, quoting Langbein and Kerwin 2000:625–26; Kobick 2010:441–42). But even if rules produced using negotiated rulemaking have a similar rate of judicial review as those produced by conventional rulemaking, using negotiated rulemaking to create new regulations may still be valuable in light of the potential benefits that negotiated rulemaking may offer compared to informal rulemaking as discussed in Part IV.F (Harter 2000:52–56).
VI. CONCLUSION
While negotiated rulemaking is not appropriate for all rulemaking, it may be appropriate and offer benefits in the current environment. To date, FDA has not used the NRA’s negotiated rulemaking process, but, to quote Harter, “[a]t the very least, regulatory negotiation is worth a try” (Harter 1982:113).
NOTES
Adapted from Marie Boyd, 2014, “Unequal Protection Under the Law: Why FDA Should Use Negotiated Rulemaking to Reform the Regulation of Generic Drugs,” Cardozo Law Review 35: 1525–85. Thanks to the organizers and participants of the 2013 Annual Conference of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School for their feedback and questions, to Chan Mo Ahn and Jessica Kelly for their research assistance, and to Vanessa Byars and Carol Young for their support. All views expressed herein are my own.
1. The manufacturer of a brand-name drug must ensure that the labeling is appropriately updated as long as the drug is marketed. When the brand-name drug labeling is updated, manufacturers are required to update the labeling of their corresponding generic drugs accordingly. But if the brand-name drug leaves the market, leaving only the generic versions, there is no manufacturer responsible for updating the labeling in light of newly acquired information because generic manufacturers cannot independently change their generic drug labeling under the current regulatory framework.
2. The FDCA permits some differences between the labeling of the RLD and generic drugs, 21 USC § 355(j)(2)(A)(v), (j)(4)(G) (2012), and FDA’s regulations provide a nonexclusive list of permissible differences, 21 CFR § 314.94(a)(8)(iv) (2014).
3. On February 18, 2015, FDA extended the comment period for the proposed rule (Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Public Meeting; Request for Comments; Reopening of the Comment Period, 80 Fed. Reg. 8577 (Feb. 18, 2015)).
4. A search of the Federal Register, the FDCA, and the United States Statutes at Large revealed no notices of FDA’s intent to establish a negotiated rulemaking committee and no instances in which Congress had required FDA to conduct negotiated rulemaking. See also Kobick 2010:425.
5. Harter identifies “Mature Issues” as one of the criteria for determining when negotiation is likely to be fruitful (Harter 1982:47).
6. Such negotiation may be consistent with the public interest; as Harter has noted, “there is some indication that rules that emerge from [negotiated rulemakings] are more stringent than those the agency would have been able to issue on its own” (Harter 1997:1403–4).
7. While this chapter does not seek to identify particular representatives for the proposed negotiated rulemaking, the mission statements of FDA, brand-name and generic pharmaceutical industry trade associations, organizations of health care professionals, and consumer advocacy groups suggest that this may be a shared value. See, e.g., “About FDA: What We Do,” Food and Drug Administration, last updated August 5, 2014, http://www.fda.gov/AboutFDA/WhatWeDo/default.htm; “About PhRMA,” Pharmaceutical Research and Manufacturers of America (PhRMA), accessed March 28, 2014, http://www.phrma.org/about; “About: The Association,” Generic Pharmaceutical Association (GPhA), accessed March 28, 2014, http://www.gphaonline.org/about/the-gpha-association; “AMA Mission & Guiding Principles,” American Medical Association, accessed March 28, 2014, http://www.ama-assn.org/ama/pub/about-ama/our-mission.page?; “Health and Safety,” Public Citizen, accessed March 28, 2014, http://www.citizen.org/Page.aspx?pid=524.
8. As noted earlier, if no consensus is reached, FDA may proceed with informal rulemaking.
9. In addition, FDA likely does not have the resources to effectively monitor and update generic drug labeling (Wyeth v. Levine 2009:578, 578 n.11). Accordingly—although not unique to negotiated rulemaking—investing in the creation of a better regulatory system, in which drug manufacturers are responsible for labeling updates and state failure-to-warn claims are not preempted, may be especially important in promoting drug safety.
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