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BENTEN v. KESSLER

July 14, 1992

LEONA BENTEN, on behalf of herself and all others similarly situated, DR. LOUISE B. TYRER, and LAWRENCE LADER, Plaintiffs, against DAVID KESSLER, in his official capacity as Commissioner of the Food and Drug Administration, CAROL HALLETT, in her official capacity as Commissioner of the Bureau of Customs, ANTHONY LIBERTA, in his official capacity as Regional Commissioner of Customs for New York, and ROBERT K. HERING, FDA Compliance Officer, Defendants.


The opinion of the court was delivered by: CHARLES P. SIFTON

 SIFTON, District Judge.

 She is right that the FDA has proceeded illegally, and she is entitled to the narrower relief she seeks, namely, the release of the drug to her. The broader remedy she asks for has not, at this juncture, been demonstrated to be necessary. The still larger question, whether RU486 should be available to women in this country, generally, is not before this Court for decision but should promptly be addressed by the agency assigned the task of resolving it according to the legal procedures mandated by Congress for resolving such issues.

 * * *

 This action -- brought by plaintiffs Leona Benten, Dr. Louise B. Tyrer, and Lawrence Lader, pursuant to the Administrative procedure Act, 5 U.S.C. §§ 706(2)(A) and 553, 21 C.F.R. § 10.70, and the United States Constitution -- seeks to secure the return of a small quantity of the abortifacient drug Mifepristone, known colloquially as RU486, seized by the defendants from two of the plaintiffs on July 1, 1992, at John F. Kennedy International Airport. In addition, the complaint seeks to enjoin the enforcement of a ban on the importation of the drug.

 The matter is currently before the Court on an application by plaintiffs seeking preliminary relief in the form of an order directing the immediate return of the drug to Ms. Benten so that she can, under the supervision of her personal physician, Dr. Tyrer, use it to terminate her pregnancy prior to July 18, 1992, after which date the drug can no longer be employed for that purpose. In addition, plaintiffs seek an order restraining defendants from implementing a ban on the importation of RU486 pending the trial of this action.

 This matter is being determined on the basis of the papers, including affidavits from the plaintiffs and others, submitted by both sides without an evidentiary hearing, with the parties' consent. *fn1"

 Having considered the affidavits and exhibits as well as the factual arguments presented both in the papers in support of and in opposition to the motion and at a hearing held on July 10, 1992, I find that plaintiffs are entitled to part of the emergency relief they seek, that is, the return of the medication for the purposes and according to the protocol set forth in plaintiff Tyrer's affidavit of July 6, 1992. The broader preliminary relief sought by the plaintiffs is, at this juncture, denied. What follows sets forth the findings of fact and conclusions of law on which these determinations are based as required by Rule 65(a) of the Federal Rules of Civil Procedure.

 BACKGROUND

 Plaintiff, Leona Benten, is a twenty-nine-year-old resident of California who is currently in her seventh week of an unwanted pregnancy. She has been pregnant before and in mid-1983 underwent a surgical abortion in a hospital ward in Oakland, California, under general anaesthesia.

 RU486 is a medical abortifacient approved and in general use in Great Britain and France, where, it is reported to have extraordinary success in achieving complete abortion and to pose acceptable health risks. L. Silvestre et al., "Voluntary Interruption of Pregnancy with Mifepristone (RU 486) and a Prostaglandin Analogue: A Large-scale French Experience," 322 New England J. Med. 645 (1990); Michael Klitsch, Antiprogestins and the Abortion Controversy: A Progress Report, 23 Fam. Plan. Persp. 275 (1991).

 RU486 is only recommended for use under medical supervision. It can be used to induce an abortion without surgical intervention or hospitalization. Therefore, RU486 abortions can be done in the privacy of one's home. However, RU486 is only recommended for use during the first eight weeks of pregnancy. The procedure involves the ingestion of 600 milligrams of Mifepristone on an empty stomach, followed forty-eight hours later by the ingestion of Cytotec (or another prostaglandin), a prescription drug generally available in the United States. The amniotic sac is generally passed as part of a flow of blood and clots several hours after the second medication is taken.

 Surgical abortion (the alternative method of ending pregnancy commonly used in the United States) is not generally recommended until the eighth week of pregnancy. Surgical abortion is generally performed at a clinic or hospital. *fn2"

 Having explained the procedure, the risks of failure, and side effects of RU486 and having obtained plaintiff Benten's consent, Dr. Tyrer prescribed the requisite dosage. Plaintiff Benten, in the company of plaintiff Lader, traveled to London, where they filled the prescription. On July 1, having alerted defendants that she would be arriving with the drug and would be seeking to import it under an exception to the ban on the importation of untested drugs described more at length hereinafter, she was met at Customs by representatives of the FDA and of Customs who seized the drug and furnished plaintiff Benten with a notice of detention describing as the "Reason for Detention(:) Automatic Detention, Alert 66-47, RPM."

 Regulatory Scheme

 In order to understand the legal morass in which the FDA has fallen in this area, it is necessary to have some understanding of how new drugs such as RU486 are regulated in this country. As a general matter, such drugs must be approved by the FDA before they may be distributed in the United States under the Federal Food, Drug and Cosmetic Act. ("FDCA"), 21 U.S.C. §§ 301 et seq. However, since Congress has not given the FDA the resources or the authority to conduct the large-scale laboratory, animal, and human studies necessary to determine the safety and effectiveness of new drugs, the burden has been placed on drug companies to come forward, sponsor the drug, and test it, submitting either a new drug application or investigational new drug application, 21 U.S.C. § 355(a)(i), (b)(1), (c)(1), and (d), to obtain FDA approval.

 The FDA possesses the authority to prohibit the importation of drugs not approved pursuant to this process, 21 U.S.C. § 381(a)(3), although it also possesses the authority in its discretion to allow the importation of new drugs which have not gone through this approval process. Id.; Heckler v. Chaney, 470 U.S. 821, 84 L. Ed. 2d 714, 105 S. Ct. 1649 91985); Community Nutrition Inst. v. Young, 818 F.2d 943, 950 (D.C. Cir. 1987).

 In July 1988, the FDA exercised this discretion compassionately to promulgate a revision of its Regulatory Procedures Manual ("RPM") addressing the situation of persons suffering from the AIDS epidemic and persons suffering from cancer who sought to import by mail small doses of untested drugs from abroad for personal use for their conditions under the supervision of their physician, in situations in which there was no reason to suspect that the persons were the victims of quacks or that the drugs posed an unacceptable risk to health. This program was announced as a temporary change in the regulations generally prohibiting the importation of unapproved drugs, and the announcement stated that, if the project "proves successful, with no significant problems, Chapter 9-71 of the Regulatory Procedures Manual may be appropriately revised." Pilot Guidance, July 20, 1988, Exhibit A to the Complaint.

 On September 26, 1988, foreshadowing the administrative confusion which has characterized latter stages of this dispute, the FDA issued Import Alert 66-813, stating that the July 20, 1988 pilot program on mail importations did not apply to RU486, presumably because the drug has nothing to do with the treatment of AIDS or cancer.

 Neither the July 20 or the September 26 revisions of agency practice were published for public comment before their promulgation. Nor, as far as this record shows, were they the product of any investigative proceeding by the agency. Perhaps this failure may be explained by their "pilot" or temporary nature.

 In all events, the pilot program was apparently judged successful and led, on February 1, 1989, to a formal revision of the agency's RPM. This revision expanded the pilot program to a substantial exception to the new drug approval procedures, no longer confined to AIDS or cancer drugs, which became known as the personal use exception. Not only was the pilot program expanded from mail imports to imports in personal luggage, the new laissez-faire approach included as well drugs for all life-threatening or serious conditions whether or not AIDS-related or the result of cancer, as well as less than serious medical conditions where the product "is not known to represent a significant health risk." The RPM reads in pertinent part as follows:

 In deciding whether to exercise discretion to allow personal shipments of drugs or devices, FDA personnel should consider a more permissive policy in the following situations:

 when the intended use is appropriately identified, such use is not for treatment of a serious condition, and the product is not known to represent a significant health risk; or

 when (1) the intended use is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means; (2) there is no known commercialization or promotion to persons residing in the United States by those involved in the distribution of the product at issue; (3) the product is considered not to represent an unreasonable risk; and (4) the individual seeking to import the product affirms in writing that it is for the patient's own personal use (generally not more than three months supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product or provides evidence that the product is for the continuation of a treatment begun in a foreign country.

 RPM 9-71-30(C).

 Once again, no notice was given of the agency's intent to adopt this major revision in the agency's regulatory stance towards unapproved drugs, nor was comment invited either before or after it was adopted. Nevertheless, unsolicited comment ...


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