Benten v. Kessler : The RU 486 Import Case

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

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

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).

Benten Plaintiffs Tyrer Leona Dr. 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.

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).

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

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.

21 U.S.C. § 381(a)(3).

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

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

RPM Chapter 9-71-30(C) (adopted February 1, 1989).

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

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

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).

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

Id.

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

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).

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).

See 5 U.S.C. § 706(2)(A).

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

Id. at 2821.

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.

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

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).

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

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

Id., slip op. at 12.

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.

Id.

Id., slip op. at 24.

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.

Id., slip op. at 16–2.0.

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).

Id., slip op. at 25.

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.

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

112 S.Ct. at 2930.

Id.

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.

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

Id. at 2931.

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).

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)