MEMORANDUM OPINION
Denying the Plaintiffs’ Motion for a Temporary Restraining Order
I. INTRODUCTION
The plaintiffs, Biovail Corporation and Biovail Laboratories International SRL *157 (collectively, “the plaintiff’ or “Biovail”) manufacture the drug Wellbutrin XL. De-fendanWIntervenor Anchen Pharmaceuticals, Inc. (“Anchen”) is awaiting defendant Food & Drug Administration’s (“FDA”) 1 approval of its generic version of Wellbut-rin XL. In December 2005, Biovail filed a citizen petition 2 with the defendant to raise Biovail’s concerns regarding.the defendant’s evaluation of generic versions of Wellbutrin XL. Specifically, the plaintiffs petition sought to ensure that the defendant applied the proper standards in determining whether the generic drugs pending FDA approval are the bioequivalents 3 of Wellbutrin XL. The plaintiff asserts that some versions of generic Wellbutrin XL may contain dangerous versions of a chemical known to cause grand mal seizures, and, as a result, the introduction of these generic drugs into the market threatens public safety and damage to Wellbutrin XL’s reputation. The plaintiff alleges that the defendant routinely withholds ruling on citizen petitions until after approving a generic drug and, consequently, eliminates any opportunity for meaningful judicial review of its decision.
The plaintiff now brings this motion for a temporary restraining order (“TRO”) alleging that the defendant violated the Administrative Procedures Act, 5 U.S.C. § 706 (“APA”), and the plaintiffs right to constitutional due process, U.S. Const. Amend. V, by failing to respond substantively to the plaintiffs citizen petition within 180 days. The plaintiff asks the court to compel the defendant to rule on the plaintiffs citizen petition one week prior to approving the generic drugs. The plaintiff also asks the court to enjoin the defendant from ruling on citizen petitions concurrent to approving Abbreviated New Drug Applications (“ANDA”). The defendant and Anchen oppose the plaintiffs motion, arguing that the defendant acted properly by issuing a tentative response within 180 days. Moreover, they assert that the defendant is not required to rule on a citizen petition prior to approving a generic drug. Because the plaintiff has not demonstrated a substantial likelihood of success on the merits of its claims or irreparable injury, the court denies the plaintiffs motion for a temporary restraining order.
II. BACKGROUND
A. Factual History
The plaintiff manufactures and sells the prescription drug Wellbutrin XL. Compl. ¶¶ 7-8, 11. Wellbutrin XL is an FDA-approved “innovator” 4 prescription drug used to treat depression. Id. ¶ 10. Well-butrin XL contains the active ingredient bupropion hydrochloride in extended-re *158 lease tablets for use in once-daily doses. Id. ¶ 13.
The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 321 et seq., allows parties seeking approval for generic forms of FDA-approved drugs to file ANDAs. Compl. ¶ 14. If an ANDA for a generic drug “relies upon the findings and safety effectiveness for the innovator drug,” the FDA may approve the generic version of the innovator drug. Id. ¶ 14. The FDA may not approve an ANDA unless the generic drug is the “bioequivalent” of the innovator drug. Id. ¶ 15.
Although no generic version of Wellbut-rin XL is currently on the market, on November 14, 2005, the FDA granted “tentative approval” to an ANDA filed by Anchen. Id. ¶ 17. Concerned that improper doses of bupropion can cause grand mal seizures, the plaintiff filed a citizen petition on December 20, 2005. Compl. ¶ 18. In its petition, the plaintiff requested that the FDA apply specific criteria in the approval process to determine the bioequivalence of any generic version of Wellbutrin XL prior to granting approval for that generic drug. Id. ¶ 18. On June 7, 2006, the defendant informed the plaintiff that it would be unable to decide the plaintiffs citizen petition within the 180-day period “because it raised complex issues requiring extensive review and analysis by Agency officials.” Id. ¶ 19. On June 29, 2006, the plaintiff sent a letter to the defendant requesting that it take immediate action on its citizen petition. Id. ¶ 21. The plaintiff claims that the defendant has failed to respond to the letter. Id.
B. Procedural History
On August 23, 2006, the plaintiff filed a motion for a TRO, requesting that the court compel the defendant to rule on the plaintiffs citizen petition. PL’s Mot. at 1. In addition, the plaintiff asks the court to require the defendant to rule on the plaintiffs petition at least one calendar week prior to granting any application for a generic Wellbutrin XL product, thereby affording the plaintiff “a meaningful opportunity to seek judicial review” if the FDA denies its petition. Id. at 1.
Because of the time-sensitive nature of the plaintiffs motion, the court ordered expedited briefing. On August 24, 2006, the defendant and Anchen opposed the plaintiffs motion by arguing that it cannot succeed on the merits of its claim because the defendant issued a tentative response regarding the plaintiffs citizen petition within 180 days. Def. FDA’s Opp’n to PL’s Mot. (“FDA’s Opp’n”) at 6. Moreover, the defendant argues that the law does not require it to respond to a citizen petition prior to ruling on an ANDA. Id. at 2. The defendant and Anchen also assert that the plaintiff demonstrates little more than speculative economic harm, which is an insufficient showing to warrant a TRO. FDA’s Opp’n at 8-11; Anehen’s Opp’n to Pi’s Mot. (Anchen’s Opp’n) at 13-16. The court now turns to the plaintiffs motion.
III. ANALYSIS
A. Legal Standard for Injunctive Relief
This court may issue interim injunctive relief only when the movant demonstrates:
(1) a substantial likelihood of success on the merits, (2) that it would suffer irreparable injury if the injunction is not granted, (3) that an injunction would not substantially injure other interested parties, and (4) that the public interest would be furthered by the injunction.
Mova Pharm. Corp. v. Shalala,
The four factors should be balanced on a sliding scale, and a party can compensate for a lesser showing on one factor by making a very strong showing on another factor.
CSX Transp., Inc. v. Williams,
Moreover, the other salient factor in the injunctive-relief analysis is irreparable injury. A movant must “demonstrate at least ‘some injury’ ” to warrant the granting of an injunction.
CityFed Fin. Corp.,
Because interim injunctive relief is an extraordinary form of judicial relief, courts should grant such relief sparingly.
Mazurek v. Armstrong,
B. The Court Denies the Plaintiffs Motion for a TRO
As discussed below, the plaintiff fails to demonstrate that it is substantially likely to succeed on the merits of its claims. Although the plaintiff demonstrates some potential for irreparable injury, the plaintiffs showing of injury is inadequate to justify the extraordinary relief of a TRO. Accordingly, the court denies the plaintiffs motion.
1. The Plaintiff Fails to Demonstrate a Substantial Likelihood of Success on the Merits
This case involves a dispute over the text of a regulation. The plaintiff alleges that the defendant violated the APA and the plaintiffs rights to due process by failing to comply with the regulation governing the defendant’s response- to citizen petitions and by routinely ruling on citizen petitions at the same time as ANDAs. Pl.’s Mot. at 12-16. The plaintiff also argues that the defendant has denied the plaintiff its property rights in Wellbutrin XL without due process. Id. at 19. Central to the plaintiffs claims is 21 C.F.R. § 10.30, which states that once a party files a citizen petition, the defendant must do ■ one of three things: (1) approve the petition, (2) deny the petition, or (3) issue a tentative response that indicates “why the *160 agency has been unable to reach a decision on the petition.” 21 C.F.R. §§ 10.30(e)(2)(I)-(iii).
The defendant asserts that it complied with the regulation governing its response to citizen petitions by issuing a tentative response to the plaintiffs petition within 180 days. FDA’s Opp’n at 6. The defendant further asserts that it is under no legal requirement to rule on citizen petitions prior to ruling on ANDAs and that the plaintiff- enjoys no property rights entitling it to due process. FDA’s Opp’n at 8. Because the defendant’s tentative response complies with the regulation, the court concludes that the plaintiff has failed to demonstrate that it is substantially likely to succeed on the merits of its APA claims.
Mazurek,
a. The Plaintiffs APA Claims
The plaintiff alleges that the defendant’s tentative response is insufficient to meet the requirements of 21 C.F.R. § 10.30. The court, therefore, analyzes the plaintiffs claims as challenges to agency inaction pursuant to the APA.
Norton v. S. Utah Wilderness Alliance,
i. Legal Standard for Judicial Review of Agency Actions
The APA entitles “a person suffering legal wrong because of agency action, or adversely affected or aggrieved by agency action ... to judicial review thereof.” 5 U.S.C. § 702. Under the APA, a reviewing court must set aside an agency action that is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”
Id.
§ 706;
Tourus Records, Inc. v. Drug Enforcement Admin.,
the agency has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.
Motor Veh. Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co.,
As the Supreme Court has explained, however, “the scope of review under the ‘arbitrary and capricious’ standard is narrow and a court is not to substitute its judgment for that of the agency.”
Motor Veh. Mfrs. Ass’n,
The court’s jurisdiction to entertain the plaintiffs challenge to the FDA’s inaction falls under section 706(1) of the APA. 5 U.S.C. § 706(1). Although civil litigants are typically able to bring suit only for
final
agency action, “agency action” includes,
inter alia,
agency “failure to act.” 5 U.S.C. § 551(13). In instances in which a litigant is challenging an agency failure to act, the APA provides relief under section 706.
Norton,
ii. The Plaintiff has Not Shown that the Defendant’s Tentative Response was Insufficient
The plaintiff concedes that the defendant issued a tentative response to the plaintiffs citizen petition, but it charges that the tentative response fails to constitute an adequate response under 21 C.F.R. § 10.30(e)(2). PL’s Mot. at 13-15. The defendant argues that it satisfied the requirements of the regulation by issuing its tentative response on June 7, 2006, which explained “why the FDA had been unable to reach a decision” on the plaintiffs citizen petition. FDA’s Opp’n at 6; Anchen’s Opp’n at 7. ■
The court begins with the plain text of the regulation.
In re England,
Again, the regulation only requires that a tentative response “indicatfe] why the agency has been unable to reach a decision on the petition.” 21 C.F.R. § 10.30(e)(2)(iii). The regulation provides that a tentative response could indicate that the agency was unable to reach a decision, “e.g., because of the existence of other agency priorities, or a need for addi
*162
tional information.”
Id.
The regulation goes on to say that “[t]he tentative response
may also
indicted the likely ultimate agency response, and
may
specify when a final response may be furnished.”
Id.
(emphasis provided). The plaintiff construes the statute as requiring a response which gives one or more of these explanations used as examples. Although the regulation indicates examples, it does not indicate that the FDA’s reasoning must be of a certain degree of detail. The court, accordingly, “declines to tinker with [the language of the regulation] by transmuting its meaning into something it does not say through judicial alchemy.”
Guam Indus. Servs., Inc. v. Rumsfeld,
Moreover, the court must defer to the defendant’s interpretation of the regulation unless it is “plainly erroneous or inconsistent with the regulation.”
Mistick PBT v. Chao,
iii. The Plaintiff has Not Shown that the Defendant is Required to Rule on a Citizen Petition Prior to Ruling on an ANDA
The plaintiff also alleges that the defendant employs a “demonstrable pattern of not deciding Citizen Petitions with respect to ANDAs until it approves ANDAs.” PL’s Mot. at 13. The plaintiff charges that the FDA routinely and deliberately “hold[s] off on deciding Citizen Petitions until the last possible moment, without regard to its obligation to decide such petitions unless it is ‘unable’ to do so.” Id. at 13-14. To the plaintiff, the defendant’s failure to timely act on citizen petitions could result in the “approval of drugs that are not. the bioequivalent to the innovator drug.” PL’s Mot. at 14.
The plaintiff, however, fails to offer any legal authority for the proposition that the defendant must rule on citizen petitions prior to approving an ANDA. Indeed, the plaintiff concedes that it “does not contend that there is [any such requirement],” PL’s Reply ¶ 2, and it offers' nothing more than allegations to support its statement that “[t]his practice is capricious and an abuse of discretion and one that poses a threat to public safety and harms the rights of those that submit Citizen Petitions.”
Id.
at 14. The plaintiff, in essence, asks the court to assume that the defendant will approve unsafe drugs' for the market if it does not respond to the plaintiffs citizen petition prior to approving the pending ANDA. Without more, however, the court fails to see how this result necessarily flows from the defendant’s practice of deciding citizen petitions simultaneously with ANDAs. Indeed, absent legal authority requiring the defendant to rule on citizen petition prior to ruling on an ANDA, the plaintiffs allegations are insufficient to demonstrate a substantial likelihood of success on the merits.
See Chaplaincy of Full Gospel Churches v. England,
b. The Plaintiffs Due Process Claim
The plaintiff also argues that it is likely to succeed on the merits of its suit because the defendant’s actions constitute a violation of the plaintiffs due process rights. Compl. ¶ 33. The defendant and Anchen assert that the plaintiff has no property right associated with the timing of the FDA’s decision, Anchen’s Opp’n at 9, or with preventing generic versions of Well-butrin XL from entering the market, FDA’s Opp’n at 7.
To establish a due process claim, the plaintiff must demonstrate that (1) it has a constitutionally protected property interest and (2) “the procedures employed deprived the plaintiff of that interest without constitutionally adequate procedure.”
Beverly Enters., Inc. v. Herman,
The plaintiff, however, cites no legal authority to support its claim that its business reputation, under these circumstances, constitutes a protected property interest. Generally, personal and business reputation are not protected by due process.
Paul v. Davis,
Assuming,
arguendo,
that Wellbutrin XL’s good reputation is protected by due process, “[t]he fundamental requirement of due process is the opportunity to be heard at a meaningful time and in a meaningful manner.”
Mathews v. Eldridge,
*164 2. The Plaintiff has Made an Insufficient Showing of Irreparable Harm
Because the plaintiff failed to show a substantial likelihood of success on the merits, it must make a “very strong” showing of irreparable harm to obtain a TRO.
Sandoz, Inc. v. Food & Drug Admin.,
The plaintiff alleges that if non-bioequivalent generic versions reach the market and cause patients treated with bupropion to suffer from
grand mal
seizures, Wellbutrin XL’s reputation would suffer. Pl.’s Mot. at 17. The plaintiff asserts that generic drugs, once approved, quickly saturate the market and, when those generic drugs are unsafe, produce a devastating effect on those with rights to the innovator drug. Pl.’s Mot. at 18 (quoting
Collagenex Pharm., Inc. v. Thompson,
It is well established that economic loss is insufficient to demonstrate irreparable injury.
Wisc. Gas Co. v. FERC,
Similarly deficient to a showing of irreparable injury is the plaintiffs claim that its reputation will suffer if the generic drugs cause grand mal seizures. The plaintiff argues that it will suffer “inevitable and irreparable harm” if a generic form of Wellbutrin XL has a higher risk than the original of serious side effects. PL’s Mot. at 2. According to the plaintiff, the negative impact of an increase in bupropion-related seizures would affect “not only the manufacturer of the dispensed generic product, but will inevitably reach Wellbutrin XL as well.” Id. at 17.
Absent evidence that the generic drug-pending approval will actually cause harmful health effects, however, these allegations fail to meet the requisite standard.
Bristol-Myers Squibb Co.,
The plaintiff also alleges that if the defendant announces a denial of the plaintiffs petition along with an approval of a generic version of Wellbutrin XL, “judicial review will follow rather than proceed [sic] harm to Biovail.” Pl.’s Mot. at 18. Moreover, the plaintiff must then “challenge simultaneously both FDA’s denial of its Petition and the Agency’s approval of the ANDA.” Id. at 19 (emphasis in original). In this circumstance, the plaintiff alleges that “it is unlikely that a TRO would take effect before Biovail suffered irreparable tarnishment to the reputation of the brand Wellbutrin XL.” Id. But, the plaintiff will still have an opportunity to appeal any denial of its citizen petition, albeit after the ANDA is approved. 21 C.F.R. 10.45(d). The plaintiff has not shown why the economic harm that may occur in the interim is sufficient to render the review of the decision meaningless. Accordingly, the plaintiff has not met its burden of demonstrating irreparable injury flowing from simultaneous decisions on its citizen petition and the ANDA.
Finally, the court notes that the plaintiff “knew there were pending Wellbutrin XL ANDAs for more than a year before it filed its citizen petition.” Anchen’s Opp’n at 15-16. On June 7, 2006, the defendant issued its tentative response to the plaintiffs petition. Compl. ¶ 19. The 180-day window in which the defendant had to respond to the plaintiffs citizen petition ended in June 2006. Therefore, the plaintiff had notice from these dates that the defendant did not intend to either approve or deny its citizen petition. The delay in filing this suit further undermines any showing of irreparable injury.
Sandoz, Inc. v. Food and Drug Admin.,
3. Other Interested Parties
The plaintiff asserts that no interested parties, including those with pending AN-DAs, will “clearly be harmed” by the relief the plaintiff seeks because the plaintiff only requests that “the FDA act on its pending Citizen Petition and provide very short notice of that action prior to issuing final approval of any ANDA for a generic version of Wellbutrin XL.” Pl.’s Mot at 20. Anchen counters that it has an “unqualified statutory right to FDA approval,” and that it would be substantially harmed if the court were to issue a TRO. Anchen’s Opp’n at 16. As the plaintiff asserts, “[w]hen a generic drug is approved, the generic drug manufacturer usually is prepared immediately to fill the distribution pipeline with its product.” Pl.’s Mot. at 3. Therefore, the court concludes that An- *166 chen and any other parties with pending ANDAs may be harmed by an injunction. 5
4. Public Interest
The plaintiff argues that unless the defendant ensures that the generic Wellbutrin XL products are the bioequivalent of Wellbutrin XL, the public will face serious health risks. Pl.’s Mot. at 2. In addition, the plaintiffs citizen petition also seeks to prevent the FDA from permitting misleading labeling relating to the safety of generic Wellbutrin XL products. PL’s Mot. at 2. It goes without saying that the public has a strong interest in preventing unsafe drugs from entering the market. At the same time, the public also has an interest in “receiving generic competition to brand-name drugs as soon as is possible,”
Boehringer Ingelheim Corp. v. Shalala,
IV. CONCLUSION
For the foregoing reasons, the court denies the plaintiffs motion for a TRO. An order consistent with this Memorandum Opinion was issued on August 25, 2006.
Notes
. The defendants are the U.S. Food and Drug Administration and Andrew C. Von Eschen-bach, M.D., in his official capacity as Acting Commissioner of Food and Drugs, U.S. Food and Drug Administration. The court refers to the defendants collectively as “the defendant” or as "the FDA.”
. When the FDA is considering the Abbreviated New Drug Applications ("ANDA”) of a generic drug, individuals with rights to or scientific knowledge of the brand name drug (known as an "innovator drug”) may provide technical information relating to the generic drug’s bioequivalence by filing a citizen petition with the FDA. Compl. ¶ 16. After receiving a citizen petition, the FDA must consider and take action on the petition within 180 days unless it is unable to do so. 21 C.F.R. § 10A0(e)(2).
. A drug is the bioequivalent of an innovator drug if "the rate and extent of absorption of the generic drug do not show a significant difference from the rate and extent of absorption of the listed drug.” 21 U.S.C. § 355(j)(8)(B).
. An "innovator” prescription drug is also referred to as a "pioneer,” "brand name,” or “branded” drug. Compl. ¶ 10.
. The plaintiff also alleges that physicians would be affected by the marketing of unsafe generic drugs in that they will either have to prescribe other bupropion products or resort to competitive products that do not contain bupropion. Pl.'s Mot. at 18. The court, however, fails to see how this cursory argument indicates a harm to physicians. Rather, this appears to be yet another incarnation of the alleged harm to the plaintiff's reputation and market share.