REQUESTED BY: Dear Senators Cullan and Wesely:
This is to advise you that United States v. Rutherford, ___ U.S. ___(1979), referred to in our Attorney General Opinion, No. 222 (February 13, 1980), did not finally decide whether Laetrile is a new drug which cannot be introduced into interstate commerce unless an application under the Federal Food, Drug Cosmetic Act (the Act) has been approved except for certain investigational use by qualified experts. That decision will come next from the 10th Circuit Court of Appeals to which the Supreme Court remanded the case for further proceedings consistent with its opinion. After that, another appeal to the Supreme Court is possible.
The circuit court should decide whether Laetrile comes within a grandfather clause which would permit its distribution if it is safe, even if not effective, and whether the FDA violated a right of privacy of terminally ill cancer patients to take a safe drug.
In the meantime, the FDA finding that Laetrile is a new drug is vacated and the FDA is enjoined from interfering with the interstate transport of Laetrile, from interfering with the use of Laetrile by terminally ill cancer patients and from interfering with medical practitioners in administering Laetrile in the care or treatment of cancer patients. See, Rutherford v. United States, 438 F. Supp. 1287, 1301 (1977). That court refused to stay its order pending appeal.