MEMORANDUM OPINION
Plaintiffs, Association of American Physicians and Surgeons (“AAPS”), Competitive Enterprise Institute (“CEI”), and Consumer Alert, bring this lawsuit to challenge the authority of the United States Food and Drug Administration (“FDA”) to promulgate “Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients” (“Pediatric Rule”), 21 C.F.R. §§ 201, 312, 314, 601, 63 Fed.Reg. 66,632 (Dec. 2, 1998). Plaintiffs claim that the Pediatric Rule exceeds the FDA’s statutory authority and that the Rule’s promulgation was arbitrary and capricious. Plaintiffs thus petition this court for relief pursuant to the Administrative Procedure Act (“APA”), 5 U.S.C. § 701 et seq.
Before this court are the parties’ cross-motions for summary judgment. Upon consideration of the parties’ submissions and the summary-judgment record, 1 the court concludes that defendants’ motion for summary judgment must be denied and plaintiffs’ motion for summary judgment must be granted.
The Federal Food Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 321 et seq., provides a systematic scheme for the approval of new drugs and new drug formulations intended to be marketed for use in interstate commerce. Under the FDCA, a new drug product cannot be marketed unless the FDA approves the product and determines that it is safe and effective for its intended use. See 21 U.S.C. § 355(a). When the FDA approves a drug, it approves the drug only for the particular use for which it was tested, but after the drug is approved for a particular use, the FDCA does not regulate how the drug may be prescribed. Thus, a drug that has been tested and approved for adult use only can be prescribed by a physician for her pediatric patients.
Because of the expense and difficulty in finding substantial pediatric populations to undergo tests, along with the ethical complications associated with testing new drugs on children, many drugs are tested for safety and effectiveness in adults only. As a result, even though there are many diseases and ailments that are common to both children and adults, physicians with pediatric patients 2 often find their treatment options limited. Some physicians, forced “to choose between prescribing drugs without well-founded dosing and safety information or utilizing other, potentially less effective, therapy” respond by prescribing adult-approved drugs to children, but in a smaller dose. See Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients, 62 Fed.Reg. 43,900 (Aug. 15, 1997).
Prescribing adult-approved drugs to children is often referred to as going “off-label.” An off-label use is the prescription of a drug by a doctor for a condition not indicated on the label or for a dosing regimen or patient population not specified on the label. Off-label use of pharmaceuticals appears to be “generally accepted” in the medical community.
See Washington Legal Found. v. Friedman,
While it is a common practice for physicians to prescribe to children pharmaceuticals only approved for adult use, by doing so, they can expose children to various hazards. Children may be given an ineffective dose or an overdose, and they face an increased risk of side effects. See 62 Fed.Reg. 43,900, 43,901. This happens because:
Correct pediatric dosing cannot necessarily be extrapolated from adult dosing information using an equivalence based either on weight ... or body surface area.... Potentially significant differences in pharmacokinetics may alter a drug’s effect in pediatric patients. The effects of growth and maturation of various organs, maturation of the immune system, alterations in metabolism throughout infancy and childhood, changes in body proportions, and other developmental changes may result insignificant differences in the doses needed by pediatric patients and adults.
62 Fed.Reg. at 43,901.
In the face of insufficient information about a new medication, pediatricians do not merely prescribe inexact doses, however. Physicians sometimes prescribe for their young patients older, less effective, but well-tested medication-as opposed to newer, more effective, medication that has not been subjected to rigorous study on pediatric populations. This practice keeps children from benefitting from state-of-the-art medication. See 63 Fed.Reg. at 66,632.
In response to these concerns, in 1994, the FDA issued a regulation requiring manufacturers of marketed drugs to survey existing data and determine whether the data was sufficient to support pediatric use information on the drug’s labeling. If so, the FDA required manufacturers to submit a supplemental new drug application seeking the FDA’s approval of the labeling change. If the drug had not been sufficiently tested on children, the rule required the manufacturer to include in the product’s labeling a statement to read: “Safety and effectiveness in pediatric patients have not been established.” 21 C.F.R. § 201.57(f)(9)(vi).
Also in an effort to encourage pediatric testing, in 1997, Congress passed the Food and Drug Administration Modernization Act (“FDAMA”), Pub.L. No. 105-115, 111 Stat. 2296 (1997). This Act established a five-year experimental program to encourage pediatric drug-testing. Under this Act, the FDA could request (but never require) manufacturers of new drugs to conduct studies on pediatric patients. Drug manufacturers that agreed to conduct these pediatric tests could receive six months of market exclusivity for their products. See 21 U.S.C. § 355a(a). Similarly, for already-marketed drugs, Congress required the FDA to publish a “list of approved drugs for which additional pediatric information may produce health benefits.” § 355a(b). The statute also contained a requirement that the FDA report to Congress on the effectiveness and adequacy of this provision by January 1, 2001. 3
Finding that the voluntary incentive provisions of FDAMA did not increase pediatric testing as much as the FDA had hoped, after proper notice-and-comment, the FDA issued the “Pediatric Rule” in 1998. 4 See 63 Fed.Reg. at 66,632; see also id. at 66,639 (providing it “does not believe ... that incentives alone will result in pediatric studies of some of the drugs and biologies where the need is greatest.”); Letter from Hubbard to Rein, 11/1/2000 at 1 (hereafter “HHS Denial”) (“the voluntary nature of the pediatric exclusivity incentive is likely to leave many drugs, age groups, and indications unstudied”); id. at 7 (“data indicate that voluntary efforts had not, by 1997, substantially increased the number of products entering the marketplace with adequate pediatric labeling”). This Rule’s legitimacy is challenged here.
In application, the Pediatric Rule distinguishes new drugs from already-marketed drugs. Manufacturers of new drugs “may be required to submit an application containing data adequate to assess whether the drug is safe and effective in pediatric
The FDA presumes that sponsors will study all new drugs in pediatric patients unless the applicant can show that waiver is appropriate. Waivers are granted if: (1) necessary studies are impossible or highly impractical because, e.g., the number of such patients is so small or geographically dispersed; or (2) there is evidence strongly suggesting that the product would be ineffective or unsafe in all pediatric age groups. 6 21 C.F.R. §§ 314.55(c)(2), 601.27(c)(2). In addition, an applicant may request a partial waiver of the above testing and development requirements if the applicant certifies that the product: (1) does not represent a meaningful therapeutic benefit for pediatric patients over existing treatments; and (2) is not likely to be used in a substantial number of pediatric patients. §§ 314.55(c)(2), 601.27(c)(2); 63 Fed.Reg. at 66,634. Partial waiver may also be available if a manufacturer can demonstrate that reasonable attempts to produce a pediatric formulation necessary for a particular age group have failed. See 21 C.F.R. §§ 314.55(c)(3), 601.27(c)(3).
For already-marketed drugs, the Pediatric Rule still applies, but it has a more narrow sweep. For such drugs, the FDA may still require a manufacturer to submit an application containing adequate evidence to support dosage and administration in some or all pediatric subpopula-tions, and the FDA may also still require an applicant to develop a pediatric drug formulation. 21 C.F.R. § 201.23(a). In this context, however, the burden is on the FDA show that such testing and analysis is required. See id. The FDA satisfies this burden only if the absence of adequate labeling could pose significant risks to pediatric patients; and either (1) the drug is “used in a substantial number of pediatric patients for the labeled indications;” or (2) there is “reason to believe that the drug product would represent a meaningful therapeutic benefit over existing treatments for pediatric patients for one or more of the claimed indications.” 21 C.F.R. § 201.23(b).
This Rule’s application, for both new and existing drugs, is limited in three other respects as well. First, the Rule does not require a manufacturer to study its product for unapproved or unclaimed indications, even if the product is widely used in pediatric patients for those indications.
See
63 Fed Reg. 66,658; FDA Denial at 7. This means that a drug marketed as a cure for one disease in adults does not need to be tested for its ability to cure an entirely different disease in children. Second, the Pediatric Rule allows drug manufacturers to defer pediatric testing until after the
When the Pediatric Rule does apply, however, it has real teeth to force compliance. If a manufacturer refuses to submit an application containing indications for pediatric use or fails to submit a requested pediatric formulation, the FDA may seek a federal court injunction to declare that the product is “misbranded or an unapproved new drug or unlicensed biologic.” § 201.23(d); 63 Fed.Reg. at 66,636. The FDA may also request that the court impose fines or subject the manufacturer to contempt proceedings. Id. In addition, in rare cases, the FDA may withdraw approval of the drug or biological product. Id.
In 1999, plaintiffs filed a citizen petition with the FDA, challenging the Pediatric Rule’s wisdom and legal authority. The FDA denied the petition in 2000, advancing essentially the same defenses it advances here. This suit, brought under the judicial review provisions of the Administrative Procedure Act (“APA”), 5 U.S.C. § 701 et seq., followed.
Since the filing of this lawsuit, Congress has passed, and the President has signed into law, the “Best Pharmaceuticals for Children Act,” Public Law No. 107-109, 115 Stat. 1408 (2002) (“BPCA”). This Act reauthorized and expanded the pediatric testing incentives set forth in FDAMA. The BPCA endorses the goal of increasing the number of drugs studied in pediatric populations but does not authorize FDA to require manufacturers to conduct pediatric testing. Instead, the Act establishes a legislative framework to encourage voluntary testing. Under the Act, a manufacturer receives an additional six months of market exclusivity on a new or marketed drug if: (1) FDA determines that pediatric testing of the drug “may produce health benefits in that population;” (2) FDA makes a written request to the manufacturer to conduct such testing; (3) the manufacturer agrees to test the drug within an appropriate time-frame; (4) the manufacturer conducts the tests and submits reports of these tests to the FDA; and (5) the FDA accepts the testing reports. See 21 U.S.C. § 355 a(a), (c).
In addition, when the FDA determines that more information about a particular drug is needed, the BPCA establishes two ways third parties may be paid to generate this information. First, the FDA may “refer the drug to the Foundation for the National Institutes of Health” (“the Foundation”), a non-profit organization, and the FDA may authorize the Foundation to collect funds for pediatric pharmacologic research and drug testing.
See
42 U.S.C. § 284m(a). The Foundation may then award a research grant to a third party who will conduct the necessary studies and provide the FDA with its final report and supporting data. § 284m(b)(6)(A). Alternatively, if the Foundation has insufficient funds to pay for the pediatric testing, the BPCA establishes a public fund of $200 million for fiscal year 2002 and “such sums as are necessary for each of the five succeeding fiscal years” that FDA may use to
If relevant new information is discovered as a result of this third-party pediatric testing, the BPCA establishes a multi-step process by which the FDA may seek product reformulations and labeling changes. If the third-party’s results indicate that a formulation change is necessary and the FDA agrees, FDA will send a “nonbinding” letter of recommendation regarding that formulation change to the drug’s manufacturer. 9 See § 284m(c)(12). Alternatively, if the FDA determines that a labeling change is necessary, the FDA must first attempt to reach agreement with the manufacturer. See 42 U.S.C. § 284m(c)(7). If the FDA and drug manufacturer are unable to agree on the proposed change, the FDA “shall refer the request” to a Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee (“Subcommittee”), which will make a labeling recommendation within ninety days. The FDA will then review the Subcommittee’s recommendation and, if appropriate, request that the manufacturer change its label accordingly. § 284m(c)(9). If the manufacturer still refuses, after thirty days, the FDA may deem the drug to be misbranded § 284m(c)(ll). In addition, the United States may bring any other appropriate enforcement action authorized under the FDCA. § 284m(c)( 11). By statute, the BPCA is to sunset in 2007.
II. ANALYSIS
A. Legal Background
Plaintiffs claim that the FDA had no authority to promulgate the Pediatric Rule. Specifically, plaintiffs argue that the “FDA has no authority to require manufacturers to (1) conduct studies of drug uses for which they do not intend to seek approval or (2) devise formulations of the drug tailored to those uses.” Pis.’ Mot. for Summ. J. at 24. 10 Plaintiffs thus petition this court for injunctive and declaratory relief. Complaint ¶ 45.
It is a basic tenet of administrative law that “an administrative agency’s power to promulgate legislative regulations is limited to the authority delegated by Congress.”
Bowen v. Georgetown Univ. Hosp.,
To begin, it is well settled that, when interpreting its own statute, the FDA is to be given deference.
See generally Udall v. Tollman,
B. The FDA’s Authority to Promulgate the Pediatric Rule
Chevron, U.S.A., Inc. v. Natural Resources Def. Council, Inc.,
Where the issue is one of whether a delegation of authority by Congress has indeed taken place (and the boundaries of any such delegation), rather than whether an agency has properly implemented authority indisputably delegated to it, Congress can reasonably be expected both to have and to express a clear intent. The reason is that it seems highly unlikely that a responsible Congress would implicitly delegate to an agency the power to define the scope of its own power. When an agency’s assertion of power into new arenas is under attack, therefore, courts should perform a close and searching analysis of congressional intent, remaining skeptical of the proposition that Congress did not speak to such a fundamental issue.
Id.
at 1567 n. 32.
See also Continental Air Lines, Inc. v. Dept. of Transp.,
To determine whether Congress has delegated to the FDA the authority to promulgate the Pediatric Rule, the court must examine the FDCA, which the FDA claims provides the basis for its authority,
12
and the ever-evolving statutory scheme, recognizing that the FDCA’s meaning “may be affected by other Acts, particularly where Congress has spoken subsequently and moré specifically to the topic at hand.”
FDA v. Brown & Williamson Tobacco Corp.,
1. The FDCA
We first turn to the FDCA, which the FDA claims serves as the basis for its authority. The FDA claims that its au
Although deference is due, it is equally true that regulations issued under 21 U.S.C. § 371(a) “must effectuate a congressional objective expressed elsewhere in the Act.”
Pharm. Manuf. Assoc. v. FDA,
a. Labeling Provisions
FDA bases the Pediatric Rule, in part, on its authority under 21 U.S.C. §~ 352(a), 352(f), 355(d)(7), and 321(n), which pertain to labeling. See
Plaintiffs claim that § 352(n) and the other labeling provisions cannot support the Pediatric Rule because, according to plaintiffs, the FDA’s ability to require manufacturers to include “adequate directions for use,” simply permits the FDA to ensure that a product bears adequate directions for its claimed uses. In addition, plaintiffs contend that these provisions give the FDA limited power-power that truly extends to only “labeling and reporting” matters. According to plaintiffs, these provisions only authorize the FDA to require manufacturers to “(a) include in their labeling certain known material facts about products and (b) report to FDA on the use of the drugs in certain circumstances.” Pis.’ Mem. in Opp. to Defs.’ Mot. for Summ. J. at 25. Plaintiffs argue that “in no event” do these statutory provisions give the FDA the authority to “require manufacturers to generate new data and formulations.” Id.
The question is a close one, however. Section 321(n) plainly provides that, in determining whether a label is misleading, the agency should look to whether the "labeling fails to reveal [material] facts under such conditions of use as are customary or usual" (emphasis added). In adopting the Pediatric Rule, the FDA ~relied on extensive evidence demonstrating that at least some drugs are "commonly" or "usually" used by children, despite the absence of pediatric labeling. 62 Fed.Reg. at 43,900-01, 43,908; 63 Fed.Reg. at 66,-636-38, 66,658. In addition, there is authority for the proposition that a label can be misleading based on what it fails to say, in addition to what is actually said.
13
See
Although § 201 (n) and the other sections regarding labeling speak to some of the matters at issue here, FDA’s power to promulgate the Pediatric Rule cannot rest solely on these provisions. Most problematic are those Pediatric Rule provisions that require manufacturers to (1) conduct studies of drugs for unclaimed uses or (2) devise formulations of the drug tailored to those uses. It is simply difficult to see how such power can be wholly derived from the FDA’s power over drug labeling. Moreover, if Congress had intended for these sections to authorize the FDA to require manufacturers to test their drugs for unclaimed uses, Congress would likely have spoken more clearly, especially since “Congress can reasonably be expected to be quite precise in defining critical jurisdictional terms going to the very power of the agency to regulate.”
Continental Air Lines, Inc. v. Dept. of Transp.,
b. “Prescribed, Recommended, or Suggested”
The FDA also relies upon 21 U.S.C. §§ 321(p), 331(a) and (d), and 355(a), (j), and (d). See 62 Fed.Reg. at 43,908. Section 321(p) defines “new drugs” as those not recognized to be safe and effective under conditions “prescribed, recommended, or suggested” in product labeling. Section 355(a) forbids new drugs’ distribution. Section 352(j), provides that a drug shall be deemed misbranded if it is “dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.” § 352(j). Sections 331(a) and (d) proscribe misbranded drugs’ sale or introduction into interstate commerce. Finally, § 355(d) provides that manufacturers seeking to market a new drug must demonstrate that the product is safe “for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof.” 21 U.S.C. § 355(d)(1).
The applicability of the above provisions all turns on what is
“prescribed, recommended, or suggested”
in a product’s labeling. Thus, the import of those three words must be scrutinized, and the analy
Plaintiffs argue that, traditionally, the FDA has required manufacturers to test products only for the product’s labeled use. The Pediatric Rule, in contrast, requires manufacturers to test products for use on children, even if such a use is not “prescribed, recommended, or suggested” by the product’s label. Plaintiffs maintain that the Rule is all the more remarkable because it requires manufacturers to test products for use on children even if, in compliance with another FDA regulation, 21 C.F.R. § 201.57(f)(9)(vi), the label specifically disclaims the product’s effectiveness for pediatric populations. Plaintiffs contend that the Pediatric Rule, therefore, conflicts with the FDCA’s plain statutory language. Pis.’ Mem. in Opp. to Defs.’ Mot. for Summ. J. at 8.
FDA counters by claiming that the Pediatric Rule does not so expand its reach. FDA argues that the Rule “simply requires, in some instances, data on a reasonable sample of patients likely to be given a drug or biological product.” Defs.’ Mem. in Supp. of Mot. for Summ. J. at 12 (citing 62 Fed.Reg. at 43,907). FDA provides that, since there is uncontroverted evidence that many drugs officially indicated for adult use are routinely used by pediatric patients, “such pediatric use is ‘suggested.’ ” Id. at 19; Defs.’ Reply Mem. in Opp. to Pis.’ Mot. for Summ. J. at 13. This is true, according to the FDA even if pediatric use is specifically disclaimed on the product’s labeling. See 63 Fed.Reg. at 66,658 (“FDA may also consider pediatric use to be ‘suggested’ in a drug’s labeling even where such use is not expressly recommended or is even disclaimed.”). 16 FDA argues, then, since “pediatric use is a ‘suggested’ use,” the FDA has authority to regulate it, under its authority to ensure that products are safe and effective for all of their suggested conditions.
The FDA reaches its conclusion by conflating what is “suggested” with what is “likely” or “foreseeable.”
17
It is this court’s task to determine whether this con
Defendants and plaintiffs each cite a number of cases that concern whether a given article is a “drug” within the meaning of the FDCA. Under the Act, that question turns on manufacturer intent. See 21 U.S.C. § 321(g)(1)(B) (defining as a drug “articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals. ..”) (emphasis added). Thus, plaintiffs and defendants spend enormous energy feuding over how manufacturer intent may be discerned.
Plaintiffs point to a number of cases which provide that to determine “manufacturer intent,” the court need only look to the manufacturer’s specific and explicit representations.
See, e.g., Brown & Williamson Tobacco Corp. v. FDA,
Defendants, on the other hand, cite cases that support a broader view. Cases cited by defendants indicate that a product’s “intended use” can be determined not only from its label but also from “promotional claims, advertising, and any other relevant source.”
Harris,
While these cases are all tangentially relevant, none really speaks to the issue at hand. Here, we are not determining whether something is a drug; we are looking to a different section of the FDCA entirely. And this section requires that a drug be safe and effective for those uses “prescribed, recommended, or suggested
in the proposed labeling.”
§ 355(d) (emphasis added).
20
The only case cited by
In
Weinberger,
the plaintiffs challenged an FDA regulation restricting the distribution of methadone. The FDA promulgated the regulation because the agency feared that methadone was being diverted from its intended use-that of a “safe, useful, and effective agent in the treatment of severe pain.”
See Weinberger,
The FDA argued for a broad reading of § 355, which would divorce the word “safe” from the rest of the statutory provision, providing the FDA with the authority to regulate methadone, not just for labeled uses, but also for possible misuses.
Id.
at 828. As explained by Judge McGowan, “The FDA contends that where there exists a documented pattern of drug misuse contrary to the intended uses specified in the labeling, the drug is unsafe for approval unless controls ... are imposed.”
Mathews,
This court concludes that use of a drug nowhere indicated by the label and, in fact, specifically disclaimed by the label is, quite simply, not “suggested” by that label. For that reason, the court finds that the FDA’s expansive interpretation of the FDCA lacks firm support in law.
The FDA’s reading also lacks support in tradition. As plaintiffs point out, in recent years, even the FDA has repeatedly stated that it may only regulate claimed uses of
I need to acknowledge the limits of FDA’s authority. It is our job to review drug applications for the indications suggested by the manufacturer. We do not have the authority to require manufacturers to seek approval for indications which they have not studied. Thus, as a matter of law, if an application contains indications only for adults, we’re stuck.
David Kessler, Speech of FDA Commissioner to the American Academy of Pediatrics (Oct. 14, 1992) (Pis.’ Mot. for Summ. J., Ex. 6). 22
In addition, the FDA’s argument proves too much. If 21 U.S.C. § 355(d) truly gave the FDA the authority that it claims, the door would be open to FDA’s regulation of all off-label uses, based solely on the manufacturer’s knowledge that those uses are common-place. This authority would surely conflict with Congress’ will
23
and would eviscerate the long-established foundation of federal food and dnig law, which allows, not the FDA, but the “manufacturer of the article, through his representations in connection with its sale, [to] determine the use to which the article is to be put.” S.Rep. No. 73-493, at 3 (1934).
See Hams,
c. Other Statutory Provisions
Lastly, given that the court is to examine the statute in context, the court must consider the effects of 21 U.S.C. § 355(c) and (d), if any. These sections provide that once the FDA has determined that the new drug is safe and effective “for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof,” and once the manufacturer meets certain other requirements not at issue here, the FDA “shall issue an order approving the application.” See 21 U.S.C. § 355(c), (d) (emphasis added). While approval appears non-discretionary once certain congressionally-prescribed conditions are satisfied, under the Pediatric Rule, the FDA can withhold approval merely because a manufacturer has failed to test the drug on children. This tension between § 355(c) and (d) and the Pediatric Rule suggests at least some inconsistency between the Pediatric Rule and the broader context of the FDCA.
For the foregoing reasons, this court concludes that the Pediatric Rule does not have a sound statutory basis in the FDCA. Next, the court must look to the evolving congressional regulation of the area to determine whether Congress intended for
2. Evolving Regulation of the Area: BPCA
As previously noted, Congress enacted the FDAMA after the FDA had drafted, but before it had issued, the Pediatric Rule. When the FDAMA sunsetted in 2002, Congress reenacted a similar statutory provision, the BPCA. These two statutes address the same issue as that addressed by the Pediatric Rule: the need for drugs to be tested on children. This situation is therefore analogous to the one faced by the Supreme Court in
Brown & Williamson;
the FDA and Congress have both spoken and have taken two different approaches to respond to the same public health issue.
Brown & Williamson
suggests that by enacting a “distinct regulatory scheme” to address a given issue, as Congress did when it enacted the BPCA, Congress demonstrates its intention to occupy the field, and any attempt by the FDA to intervene with an inconsistent regime shall be deemed in excess of its authority.
a. The Legislative History is Inconclusive
On the other hand, militating in the Pediatric Rule’s favor is the fact that, when enacting the BPCA, Congress failed to expressly reject the Pediatric Rule, even though Congress was well aware of its existence. Generally, Congress’ “failure to revise or repeal the agency’s interpretation is persuasive evidence that the interpretation is the one intended by Congress.”
Young v. Cmty. Nutrition Inst.,
Some affirmative legislative history does support the Pediatric Rule, however. This history may be found in the Senate Report accompanying the BPCA. The Report provides:
[The Pediatric Rule] requires the manufacturers of certain new and marketed drugs and biological products to provide adequate labeling for the use of the products in children. The rule is both broader and narrower than the pediatric exclusivity provision enacted by congress in 1997. When them scopes overlap, Congress provided that pediatric studies required under the rule could also satisfy the requirements for market exclusivity.
S.Rep. No. 107-79, at 4 (2001). This language demonstrates some desire for the Pediatric Rule to exist along-side Congress’ scheme, and it is somewhat persuasive. However, given that the relevant legislative history is contradictory, 26 this statement shall not be accorded undue weight.
Given this conflicting authority, the court turns to the BPCA and Pediatric Rule themselves to determine whether the two regimes are indeed “perfectly harmonious,” as the FDA claims. Defs.’ Reply Mem. in Supp. of Mot. for Summ. J. at 18. After careful analysis, the court finds that they are not; the two methods of solving the same problem differ in key respects and are, in fact, incompatible.
Congress adopted an incentive scheme while the FDA adopted a command and control approach. The two schemes differ in almost every possible regard. First, as far as drug approval, the Pediatric Rule gives the FDA the authority to refuse to approve new drug applications if manufacturers refuse to conduct pediatric studies. The BPCA does not. Second, in terms of drug testing on pediatric populations, the Pediatric Rule provides that the FDA may “require” manufacturers to tests new drugs on pediatric populations. In contrast, the BPCA provides these tests may be merely “requested,” and the BPCA establishes a public fund to pay for third parties to conduct pediatric tests if the FDA determines that such tests are necessary but the manufacturer elects not to conduct them. See 42 U.S.C. § 284m(c)(l) and (d). For already-marketed drugs, the BPCA, unlike the Pediatric Rule, allows manufacturers to decline to conduct pediatric testing without any risk that their products will be deemed misbranded and pulled off the market. As for labeling changes, the BPCA sets up an elaborate scheme to force labeling changes if, as a result of what was unearthed during pediatric testing, the FDA determines that such changes are necessary. See § 284m (c)(8), (9). In contrast, the Pediatric Rules gives the FDA the authority to simply declare a drug misbranded. In regard to pediatric formulations, the Pediatric Rule requires their development, but the BPCA provides that the FDA “shall send a nonbinding letter” recommending a change in formulation “if a pediatric study completed under public contract indicates that a formulation change is necessary and the Secretary agrees.” § 284m(e)(12). Finally, the very thrust of the BPCA-providing marketing incentives to encourage voluntary testing-is entirely anomalous with the very thrust of the Pediatric Rule-requiring such tests in the absence of a deferral or waiver.
Far from complementing Congress’s voluntary incentive scheme, the Pediatric Rule usurps it by superimposing an often-incompatible regime. This case, therefore, is like
Ragsdale v. Wolverine World Wide, Inc.,
Here, Congress clearly considered a command and control approach. During passage of FDAMA (BPCA’s predecessor), Senator Christopher Dodd, one of the cosponsors of FDAMA’s pediatric exclusivity provisions stated that in drafting these provisions:
[I]n 1997 ... there was a debate on whether we should mandate [pediatric drug testing provisions] and say you have to do it whether you like it or not, which is one approach, or should we say we will give you a chance to prove to us you can do it by providing 6 months of exclusivity in the marketplace....
147 Cong. Rec. S10826 (daily ed. October 18, 2001). Congress opted for the latter
III. CONCLUSION
In its submissions to this court, the FDA provides, time and time again, that “[i]t is significant that drug manufacturers, who are those most affected by the Pediatric Rule, are not complaining about the requirements.” Defs.’ Reply Mem. in Supp. of Mot. for Summ. J. at 1. In so arguing, the FDA misses the point. This court does not pass judgment on the merits of the FDA’s regulatory scheme. The Pediatric Rule may well be a better policy tool than the one enacted by Congress; it might reflect the most thoughtful, reasoned, balanced solution to a vexing public health problem. The issue here is not the Rule’s wisdom. Indeed, if that were the issue, this court would be a poor arbiter indeed. The issue is the Rule’s statutory authority, and it is this that the court finds lacking.
For the foregoing reasons, this court finds that the Pediatric Rule exceeds the FDA’s statutory authority and is therefore invalid. Accordingly, plaintiffs’ motion for summary judgment is granted, and defendants’ motion for summary judgment is denied. An appropriate order accompanies this memorandum.
ORDER
Pursuant to Fed.R.Civ.P. 58 and for the reasons stated by the court in its memorandum opinion docketed this same day, it is this 17th day of October, 2002, hereby
ORDERED that judgment is entered in favor of plaintiffs; it is further
ORDERED that the Food and Drug Administration and the Department of Health and Human Services, and all persons acting under their direction or authority, or in active concert or participation with them, are hereby enjoined from enforcing the Pediatric Rule.
Notes
. The court has also considered the views of the amici curiae, the American Academy of Pediatrics, the Elizabeth Glaser Pediatric AIDS Foundation, and the Pediatric Academic Societies.
. The FDA defines "pediatric patients” as "the pediatric age group, from birth to sixteen years, including age groups often called neonates, infants, children, and adolescents.” See 21 C.F.R. § 201.507(0(9). In this memorandum opinion, those in the age group affected by the Pediatric Rule will be referred to both as "pediatric patients” and as "children.”
. The FDA provided this Status Report to Congress in January 2001. The Report provided that the "pediatric exclusivity provision has been highly effective in generating pediatric studies of many drugs and in providing useful new information in product labeling.” Status Report to Congress at i.
. The Pediatric Rule was actually proposed in 1997, finalized in 1998, and became effective on April 1, 1999. Manufacturers have been required to submit pediatric testing mandated by the Rule since December 2, 2000.
. The term "meaningful therapeutic benefit” is defined as a significant improvement in the treatment, diagnosis, or prevention of a disease, compared to marketed products adequately labeled for that use in the relevant pediatric population. 21 C.F.R. § 314.55(c)(5).
. If a waiver is granted because the manufacture shows that the product would be ineffective or unsafe in pediatric populations, this information must be included on the product's labeling. See 21 C.F.R. § 201.23(c)(3).
. Deferrals may be granted if, among other reasons: (1) the drug is ready for approval in adults before studies in pediatric patients are complete; or (2) pediatric studies should be delayed until additional safety or effectiveness data have been collected. § 314.55(b).
. A suitability petition is a petition to file an Abbreviated New Drug Application for a product that differs from an approved pioneer drug in its route of administration, dosage form, or strength. See 21 U.S.C. § 355Q)(2)(C); 21 C.F.R. § 314.93.
. The more precise term is "holder(s) of an .approved application,” but for ease of reference, the term "manufacturer” is used.
. Plaintiffs also attack the Pediatric Rule on a number of other bases. First, they claim, the FDA has never shown that the purported absence of pediatric labeling information poses significant risks to children and in the absence of such a showing, "the agency’s decision should be rejected.” Pis.' Mot. for Summ. J. at 40 (citing
Burlington Truck Lines, Inc. v. United States,
. The FDA relies heavily on the Supreme Court’s recent decision in
United States v. Mead Corp.,
. If statutory language is unambiguous and "the statutory scheme is coherent and consistent,” the inquiry begins and ends with statutory text.
See Robinson v. Shell Oil Co.,
. FDA also points to 21 U.S.C. §§ 355(i) and (k) as well as 42 U.S.C. § 262.
See
62 Fed.
. FDA spends considerable energy arguing that "[a]gencies are permitted to promulgate requirements that are not stated explicitly in the authorizing statute.” Defs.’ Reply Mem. in Supp. of Mot. for Summ. J. at 10. FDA argues, for' instance, that 21 C.F.R. § 201.57 spells out exactly what headings drug labels should include (e.g., Description, Clinical Pharmacology, Indications and Use, etc.), even though the "statute says very little about the content of drug labeling, let alone section headings or the order for such headings.”
Id.
at 10. This
misses
the
point,
however. No one challenges the FDA’s authority to promulgate rules in the "exercise [of] its judgment as to how best to implement a general statutory mandate.”
Am. Mining Congress v. MSHA,
. The following analysis highlights § 355(d), since the FDA emphasizes that section and, according to Judge McGowan, § 355(d) is the "pivotal provision of the Federal Food, Drug, and Cosmetic Act.”
Am. Pharm. Assoc. v. Mathews,
. In FDA Denial at 8, FDA reiterated this exact (and unfortunate) position.
. The FDA also relies on its own regulation defining the term "intended uses.” This definition provides, in part, that a manufacturers’ intent "may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised.” 21 C.F.R. § 201.128. While this definition is surely broad enough to encompass the circumstance here, that fact is of no legal consequence because "no order or regulation issued by an administrative agency can confer on it any greater authority than it has under statute.”
Office of Consumers' Counsel v. FERC,
.
See also,
e.g.,
Nat'l Nutritional Foods Ass'n v. Mathews,
.
See, e.g., United States v. Storage Spaces Designated Nos. "8” and “49",
.At times, the FDA appears to argue that pediatric use is not “off-label” use but rather use for labeled indications in a distinct patient population. It has long been recognized that pediatric use is off-label use.
See Washington Legal Found. v. Friedman,
.
Weinberger’s
use of the word "intended” has potentially led the FDA to conclude that the instant inquiry melts into an inquiry of "intended” under 21 U.S.C. § 321(g)(1)(B), the statute governing the definition a drug under FDCA. Such an interpretation would be inappropriate. The court must, as always, base its decisions in the plain meaning of a statute, if that statute is clear, and the court must “give effect to all words of a statute when construing it.”
State of N.J., Dept. of Envtl. Prot. and Energy v. Long,
. The court recognizes that these comments are not binding on the FDA and do not represent the FDA’s "formal position.”
See
21 C.F.R. § 10.85(k). Nevertheless,
like
the Fourth Circuit in
Brown & Williamson,
the court finds these statements to be illuminating.
See Brown & Williamson,
. See H.R. Conf. Rep. No. 105-399, at 97 (1997), reprinted in 1997 U.S.C.C.A.N. 2880-2887 ("The off-label use of a medical device by a physician using his or her best medical judgment in determining how and when to use the medical product for the care of a particular patient is not the province of the FDA.”).
. FDA cites extensively to
Pfizer v. Shalala,
. In fact, two Senators did contemplate giving the FDA such authority. "Senator Kennedy offered and then withdrew an amendment to require pediatric testing of new drugs for their approved uses in adults." S.Rep. No. 107-79, at 7 (2001). In addition, Senator Clinton offered and then withdrew an amendment to "require manufacturers to include in an application for study of a new drug their intent for pediatric studies of the drug.” Id.
. For instance, the House Report that accompanied the FDA Modernization Act ("FDAMA”) stated that "FDA has no authority to regulate how physicians prescribe approved drugs in the context of their medical practice. Physicians prescribing off-label uses of approved drugs is not within the jurisdiction of the FDA.” H.R.Rep. No. 105-310, at 60 (1997). This Report provides some evidence of Congress’ intent for such off-label use not to be regulated. This conflicting authority further underlines the fact that looking to legislative history can sometimes be akin to "looking over a crowd and picking out your friends.”
United States v. Bohai Trading Co., Inc.,