It is not necessary that the request for such administrative relief be made by any of the defendants if made by any other responsible medical practitioner or institution.
In sum, with respect to the federal defendants, plaintiff is permitted to seek prospective relief challenging any federal agency refusal to waive upon request any regulatory prohibition blocking her from continuing to receive an investigational medication previously administered to her as party of a study. Any claim that federal agencies or personnel must require a hospital or other administrator of a medical study to provide a drug is dismissed.
Discovery is stayed until a ruling is made with respect to viability of plaintiff's remaining claims. The defendant hospital must supply a statement to this court as of forty-five (45) days of the date of this memorandum order, as to whether or not any requests have been made to any federal agency seeking approval of, or waiver of any barrier to, continued administration of the drug involved to plaintiff.
The submissions plaintiff is permitted to make by this memorandum order shall be provided within forty (40) days of the date of this memorandum order based upon information available to plaintiff without discovery except as noted above.
Except as outlined above, the United States Attorney's motion is denied without prejudice.
Because of the importance of investigational pharmaceutical testing, it is important to set forth at the outset those rulings now made finally or tentatively which will function to protect those conducting such tests:
(a) No damage suits against any federal agencies or personnel are authorized.
(b) Federal law does not require anyone conducting such testing to continue anyone in a testing program or to continue to provide the product being tested.
Unless otherwise shown, it also appears that for reasons outlined below, federal law precludes any state law requirement that participation in a federally sponsored drug testing program entitles a participant to continue to receive the drug being tested, although breach of contract claims under state law may, if independently viable and not barred by defenses not mentioned above, be pursued.
The court has subject matter jurisdiction under 28 USC 1331 over claims arising under federal law. See Bowen v. United States, 485 U.S. 991, 99 L. Ed. 2d 508, 108 S. Ct. 1299 (1988).
A procedural framework for private suits challenging federal agency action or inaction was established by the Administrative Procedure Act, permitting challenge to be brought in the district courts where a private party is adversely affected by final agency action claimed to be contrary to law. 5 USC 702; see Abbott Laboratories v. Gardner, 387 U.S. 136, 18 L. Ed. 2d 681, 87 S. Ct. 1507 (1967). The APA constitutes a waiver of sovereign immunity with respect to equitable relief but not damages where a violation of federal law supporting relief under the Act can be shown. Alabama v. Bowsher, 734 F. Supp. 525 (DDC 1990); see Bowen, supra. APA coverage, however, is not necessary for subject matter jurisdiction under 28 USC 1331. Air Courier Conference v. Postal Workers, 498 U.S. 517, 523 n 3, 112 L. Ed. 2d 1125, 111 S. Ct. 913 (1991); Califano v. Sanders, 430 U.S. 99, 105, 51 L. Ed. 2d 192, 97 S. Ct. 980 (1977).
Existence of subject matter jurisdiction does not necessarily mean that relief can be granted. See Bell v. Hood, 327 U.S. 678, 90 L. Ed. 939, 66 S. Ct. 773 (1946). A violation of law and appropriateness of the relief are both necessary for that purpose. See Webster v. Doe, 486 U.S. 592, 100 L. Ed. 2d 632, 108 S. Ct. 2047 (1988).
Monetary relief beyond recovery for confiscatory acts raising constitutional questions or recovery authorized by specific statutes may have adverse effects on the deep-pocketed federal Treasury. In part for this reason, suits against federal agencies for damages in their regulatory as distinct from proprietary capacity is limited to situations where a statute expressly or impliedly so indicates. United States v. Mitchell, 463 U.S. 206, 77 L. Ed. 2d 580, 103 S. Ct. 2961 (1983).
In order to protect the public from unsafe or ineffective pharmaceuticals, the federal Food, Drug and Cosmetic Act requires advance approval of New Drug Applications by the United States Food and Drug Administration prior to their distribution. See United States v. Generix Drug Corp, 460 U.S. 453, 75 L. Ed. 2d 198, 103 S. Ct. 1298 (1983). The delays inherent in the testing necessary for approval has been recognized as presenting a problem requiring reasonable steps to expedite action where feasible and to minimize resultant hardships. Burroughs Wellcome Co v. Schweiker, 649 F.2d 221 (4th Cir 1981); Drug Price Competition and Patent Term Restoration Act of 1984, Public Law 98-417, 98 Stat 1585; see Westwood v. Cohen, 838 F. Supp. 126 (SDNY 1993).
Where other effective treatments are unavailing, prescription of medications not yet approved for general distribution have been authorized for compassionate reasons, especially since 1980. See 21 USC 355; 21 CFR 312; Hearings before the Subcommittee on Health, Committee on Energy & Commerce, 97th Cong, 1st Sess 49 (March 9, 1991); Ahern, "Drug Approval in the United States and England," 17 Suffolk Transnational L Rev 93 (Winter 1994); Henry, "Problems With Pharmaceutical Regulation in the United States," 14 J Legal Medicine 617 & n 51 (Dec 1993); Panel Discussion, 45 FDC LJ #4 at 327 (1990).
The Food and Drug Administration has thus increasingly recognized that a rigid regulatory prohibition on continued administration of a product previously permitted to be provided to a patient as part of an investigation, would appear to serve none of the public purposes for which the statutes involved were enacted. Neither 21 CFR nor the objectives of the statute do not preclude consideration on the merits of applications for waiver of a barrier to administration of an investigational drug if made by a responsible medical practitioner or institution.
As stated by Chief Justice Stone in United States v. Classic, 313 U.S. 299, 317-18, 85 L. Ed. 1368, 61 S. Ct. 1031 (1941):
To decide, we turn to the words [of the document involved] read in their historical setting as revealing the purposes of its framers, and search for admissible meanings of its words which, in the circumstances of their application, will effectuate those purposes.