a more lenient basis than required by existing law? While the court understands Grandfather clauses, if one does exist in this case, they have no place where the public safety is involved.
Even assuming arguendo that the FDA need not apply its regulations on inactive ingredients to its consideration of the Repronex ANDA, it is uncertain whether the agency's decision meets the requirements of the Hatch-Waxman Amendments. The Court refers back to the FFDCA and its legislative history. See, generally, H.R. Rep. No. 857, 98th Cong. 1st Sess., pt. 1, at 36 (1984), reprinted in 1984 U.S.C.C.A.N. 2647, 2669 (explaining that ANDAs submitted before the effective date of the generic drug approval regulations "may be submitted in accordance with current regulations."). While the Hatch-Waxman Amendments of 1984 do not specifically require that the inactive ingredients of a generic drug be identical to those of the pioneer, they state that an ANDA must be denied if the drug's inactive ingredients make it unsafe. 21 U.S.C. § 355(j)(3)(H)(i).
The tentativeness of the agency's conclusion that "the difference in the amount of lactose present in [Repronex] does not raise serious questions of safety" is not reassuring. A.R. at 434 (emphasis added). The record makes clear that there has been debate within the FDA as to whether a full NDA should be required of Repronex.
This is not an area where the FDA can cut comers. The FDA shall either require a NDA of Repronex or establish a fuller basis on the record as to why a NDA is unnecessary.
II. Serono Will Suffer Irreparable Harm Unless the Court Grants a Preliminary Injunction
Serono will suffer irreparable injury in the absence of a preliminary injunction preventing Ferring from marketing Repronex in the United States. The analysis here is one of simple economics. A change in the number of manufacturers of a given drug product will change each manufacturer's market share, and those who lose market share are irreparably harmed. Allegran v. Shalala, 6 Food and Drug Rep. 389, 391, No. 94-1223 (D.D.C. Nov. 10, 1994). The FDA's approval of the Repronex ANDA would change the number of menotropins products in the market from two to three, with a corresponding loss of market share and revenue for Serono's Pergonal. In sum, Plaintiff represents that it expects "an annual loss of up to $ 50 million - nearly a 25% drop from the company's total 1996 revenues ($ 207 million) for all products, causing irreparable and severe economic harm to Serono." Memorandum of Points and Authorities in Support of Plaintiff's Motion for a Preliminary Injunction, p.38. Plaintiff also represents that it is in imminent danger of sustaining irreparable injury to the goodwill earned by its product during the past twenty-eight years.
The government argues that Plaintiff's fear of lost revenue and reputation is too speculative to constitute "irreparable harm" and falls short of the harm necessary to justify emergency injunctive relief. The government also claims that Plaintiff, a part of the multinational "Ares-Serono Group," can afford to endure economic loss while this matter is litigated and that such loss is not then "irreparable."
This Circuit has long used a flexible approach in weighing the preliminary injunction factors. See, e.g., Bracco Diagnostics, Inc. v. Shalala, 963 F. Supp. 20, 1997 U.S. Dist. LEXIS 5638 at *15 (D.D.C. April 21, 1997)(preliminary injunction factors "must be viewed as a continuum")(citing Washington Metropolitan Area, Etc. v. Holiday Tours, Inc., 182 U.S. App. D.C. 220, 559 F.2d 841, 843 n.3 (D.C. Cir. 1997)). While Plaintiff's actual and reputational losses can only be speculative, it is clear to this Court that Plaintiff's economic losses, at the very least, will be substantial in absolute terms.
What is more, any loss by Serono is not recoverable due to governmental immunity.
Plaintiff will be irreparably harmed if a preliminary injunction is not granted in this case.
III. The Balance of the Harms and Public Interest Both Favor a Preliminary Injunction
On balance, the public interest will be served in this case by granting Plaintiff's motion for a preliminary injunction. It is true that this injunction will delay the introduction into the market of a lower-priced generic drug. The Court recognizes that "the purpose of [the Hatch-Waxman Amendments] was to increase competition in the drug industry by facilitating the approval of generic copies of drugs." Mead Johnson Pharmaceutical Group v. Bowen, 267 U.S. App. D.C. 382, 838 F.2d 1332, 1333 (D.C. Cir. 1988).
"There is a strong public interest in meticulous compliance with law by public officials." Fund for Animals v. Espy, 814 F. Supp. 142, 152 (D.D.C. 1993). Here the FDA violated both the FFDCA and its own implementing regulations by approving a generic infertility product that, by the FDA's own admission, is not the same as the pioneer drug it seeks to copy. The FDA took such action in the face of information, studies and internal debate indicating that such differences between Pergonal and Repronex could present problems of safety and efficacy.
The public has a tremendous interest in ensuring that the FDA only approve generic drugs that are the same as the pioneer drugs they purport to copy. That is certainly true for patients undergoing fertility treatment with menotropins products. Because the reproductive potential of each woman declines with age, and this occurs quite rapidly, any lost cycle (usually of a month's duration) will contribute to the loss of reproductive potential if the fertility treatment is ineffective. FDA's finding of "therapeutic equivalence" and "AB" rating for Repronex could cause physicians to switch patients from Pergonal to Repronex in the middle of a fertility cycle. Yet, because the ingredients in Repronex are different from Pergonal, patients may lose the opportunity for conception and could be exposed to side effects resulting from administration of different menotropins products. See Plaintiff's Exh. Nos. 1 and 2.
While generic drugs provide the public with immediate cost savings, more is at stake. The U.S. has made tremendous strides in developing new medicines to cure the sick. To develop a new medicine requires the expenditure of a great deal of money and many years of testing to establish its safety and efficacy. The reasonable costs of developing new curative drugs must be able to be recouped by our research and pioneering pharmaceutical companies. The Congress certainly has every right to find that at times those companies may have gouged the public. To make certain allowances for the production of generic copies of "the real thing" without unduly cutting back on new drug research certainly will benefit the public. It is clear, however, for this policy to be effective there can be no short cuts. For the public safety, the generic drug must have the same therapeutic effect as the original. If this cannot be appropriately documented, the generic drug must not receive FDA approval without full testing as to the its safety and effectiveness. The record does not show that Repronex is a safe and effective equivalent of Pergonal. It will serve the public interest to grant a preliminary injunction in this case.
Plaintiff's motion for a preliminary injunction will be granted. The Court will preliminarily enjoin the FDA from approving the Ferring ANDA and will compel the FDA to rescind immediately its designation of an "AB" rating in the Orange Book. An appropriate order is attached hereto.
July 25, 1997
United States District Judge
This matter is before the Court on Plaintiff's motion for a preliminary injunction. The Court has considered the motion and the opposition thereto and heard argument on July 1, 1997. For the reasons cited in the accompanying Memorandum Opinion, it is hereby
ORDERED that Plaintiff's motion is granted; and it is
FURTHER ORDERED that, pending a trial of the permanent injunction, the FDA is preliminarily enjoined from approving the Ferring ANDA; and it is
FURTHER ORDERED that the FDA rescind immediately its designation of an "AB" rating for Repronex in the Orange Book.
July 25, 1997
United States District Judge