Excerpt from a presentation by the author, Pine, Rachael N., at American Society of Law & Medicine meeting, Toronto, Canada (July 1992).Google Scholar

Complaint, Benten et al. v. Kessler et al., No. 92-3161 (E.D.N.Y. filed July 7, 1991).Google Scholar

The ban is largely symbolic in effect because the French company that manufactures RU ₄86, Roussel-Uclaf, has never applied to the FDA for the regulatory authority to test and distribute the drug in the U.S. Such FDA regulatory approval, following an appropriate application by the manufacturer, see note 7 infra, would be unaffected by the import ban, which applies only to drugs not approved through this process. The company's decision not to seek approval for full scale marketing of the drug is a consequence of its perception that doing so in the present political climate could present long-term economic liabilities for Roussel and its German parent company. See Reproductive Health Technologies Project, The Case for Antiprogestins at 13–14 (1992).Google Scholar

Benten, Plaintiffs Leona, Dr.Tyrer, Leona and Lade, Lawrence were represented by Heller, Simon, Esq. and the author from The Center for Reproductive Law and Policy and by Marshall Beil, Esq. of the firm of LeFrak, Newman and Myerson.Google Scholar

See Benten v. Kessler, 112 S. Ct. 1919 (1992) (denial of application to vacate stay of district court's order releasing the drugs to plaintiff Leona Benten).Google Scholar

See Memorandum Decision and Order, Benten v. Kessler, No. 92-3161 (E.D.N.Y. July 14, 1992); see discussion infra.Google Scholar

See 21 U.S.C. § 301 et seq. This regulatory approval process ordinarily follows the filing of an Investigational New Drug Application (IND), id. at § 355(a)(1), and/or a New Drug Application (NDA), id. at § 355(c), by the drug sponsor.Google Scholar

21 U.S.C. § 381(a)(3).Google Scholar

Id.; Heckler v. Chaney, 470 U.S. 821 (1985); Community National Inst. v. Young, 818 F.2d 943, 950 (D.C. Cir. 1987).Google Scholar

FDA Pilot Guidance (July 20, 1988) (revising Regulation Procedures Manual Chapter 9–71 on a pilot basis).Google Scholar

The final version of what has become known as the “personal use” rule 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 Chapter 9-71-30(C) (adopted February 1, 1989).Google Scholar

FDA Import Alert 66–813 (issued September 26, 1988).Google Scholar

FDA Import Alert 66–47 (issued June 6, 1989).Google Scholar

See generally Benten v. Kessler, No. 92–3161, slip op. at 8–12 (discussing the history of the current import ban and the political pressure that led to its issuance).Google Scholar

See FDA Import Alert 66–47 (issued June 6, 1989).Google Scholar

Id.Google Scholar

Benten v. Kessler, No. 92–3161, slip op. at 12.Google Scholar

Benten v. Kessler, 112 S. Ct. at 2931 (Stevens, J, dissenting) (Opinion of the Court did not discuss the safety record of RU ₄86 at all). For a complete review of the medical literature demonstrating the safety and effectiveness of RU ₄86 as an abortifacient when coupled with an appropriate prostaglandin, see Irving Spitz and C. Wayne Bardin, RU 486 (1992) (available from the Institute of Biomedical Research of the Population Council, New York, NY); Michael Klitsch, Antiprogestins and the Abortion Controversy: A Progress Report, 23 Fam. Plan. Persp. at 275 nn. 5–6 (1991).Google Scholar

See 5 U.S.C. § 553(b). See generally Bellarno International Limited v. Food and Drug Administration, 678 F. Supp. 410 (E.D.N.Y. 1988) (FDA import alert providing for detention and re-exportation of over-the-counter drugs found to be invalid due to lack of public notice and comment).Google Scholar

See 5 U.S.C. § 706(2)(A).Google Scholar

Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 416 (1971).Google Scholar

Planned Parenthood of Southeastern Pennsylvania v. Casey, 112 S. Ct. 2791, 2820 (1992) (O'Connor, Kennedy, Souter, JJ.). In an opinion by Justices O'Connor, Kennedy, and Souter, the Court articulated and explained a new “undue burden” standard as follows: To protect the central right recognized by Roe v. Wade while at the same time accommodating the State's profound interest in potential life. We will employ the undue burden analysis as explained in this opinion. An undue burden exists, and therefore a provision of law is invalid, if its purpose or effect is to place a substantial obstacle in the path of a woman seeking an abortion before the fetus attains viability. Id. at 2821.Google Scholar

Tight control of access to RU ₄86 by its manufacturer, Roussel-Uclaf, and by the regulatory authorities of countries like Britain and France, which have approved the drug's use, insure that few women will be able to obtain even a personal dose of the drug for importation purposes.Google Scholar

Benten v. Kessler, 112 S. Ct. at 2930 (Stevens, J. dissenting).Google Scholar

While prevailing surgical methods of abortion are exceedingly safe and effective in the U.S., physical and psychological factors can render a non-surgical method, in the form of RU ₄86, preferable. Such drug-induced abortion is less invasive, more private and more natural, in the sense that it resembles a miscarriage. See Marge Berer, Inducing a Miscarriage: Woman-Centered Perspectives on RU ₄86/Prostaglandin as an Early Abortion Method (this issue).Google Scholar

See Complaint, Benten v. Kessler, No. 91–3161.Google Scholar

Benten v. Kessler, No. 92–3161, slip op. at 2.Google Scholar

Id., slip op. at 12.Google Scholar

Congressman Dornan urged, inter alia, that “[t]he U.S. government should not be involved in abetting abortion. This includes regulations that would allow the use of abortifacients such as RU ₄86.” Letter of Congressmen Dornan, Hyde and LaFalce to then- Commissioner of the FDA, dated May 5, 1989, cited in Benten v. Kessler, No 92–3161, slip op. at 10–11.Google Scholar

Id.Google Scholar

Id., slip op. at 24.Google Scholar

Id., slip op at 14. Responding to the goverment's suggestion that Leona and her physician simply turn around, get back on a plane, and perform the abortion procedure in a “hotel room in Paris or London,” the court noted the regulatory restrictions in these countries, the interest of Ms. Benten in obtaining her medical care at home and concluded that the suggestion “mistakes the role of equity.” Id. slip op at 15–16.Google Scholar

Id., slip op. at 16–20.Google Scholar

Id., slip op. at 20–21, citing Vargas v. INS, 938 F.2d 360, 363 (2d Cir. 1991); Detsel by Detsel v. Sullivan, 895 F.2d 58, 63–64 (2d Cir. 1990).Google Scholar

Id., slip op. at 25.Google Scholar

Id., slip op at 23. As stated above, the court was not asked to reach the constitutional issues in the context of the motion for urgent relief for Leona Benten.Google Scholar

Benten v. Kessler, 112 S.Ct. 2929.Google Scholar

112 S.Ct. at 2930.Google Scholar

Id.Google Scholar

While the Benten case as a whole is not, technically speaking, moot, for all practical purposes it may well have run its course in the courts.Google Scholar

Benten v. Kessler, 112 S.Ct. at 2930 (Stevens, J., dissenting).Google Scholar

Id. at 2931.Google Scholar

See Id. at 2930 (weighing “the relative significance of the burden [on the exercise of the constitutional right] …and the governmental interest at stake” under the Court's new “undue burden” analysis).Google Scholar

See generally Pine, Rachael N. and Law, Sylvia, Envisioning a future for Reproductive Liberty; Strategies for Making the Rights Real, 27 Harv. C.R.-C.L. 407, 441–42 (Summer 1992)Google Scholar