AMERICAN HOME PRODUCTS CORPORATION v. Richardson, Civ. A. No. 3744.
| Decision Date | 28 June 1971 |
| Docket Number | Civ. A. No. 3744. |
| Citation | 328 F. Supp. 612 |
| Court | U.S. District Court — District of Delaware |
| Parties | AMERICAN HOME PRODUCTS CORPORATION, Plaintiff, v. Elliott L. RICHARDSON, Secretary of Health, Education and Welfare, and Charles C. Edwards, Commissioner of Food and Drugs, Defendants. |
William E. Wiggin, of Richards, Layton & Finger, Wilmington, Del., Andrew J. Kilcarr, and Joseph E. Fortenberry, of Donovan, Leisure, Newton & Irvine, Washington, D. C., and John R. Stafford, New York City, of counsel, for plaintiff.
F. L. Peter Stone, U. S. Atty., and Norman Levine, Asst. U. S. Atty., Wilmington, Del., John L. Murphy and Howard Epstein, Attys. U. S. Dept. of Justice, Washington, D. C., and William W. Goodrich, Asst. Gen. Counsel, United States Dept. of Health, Education and Welfare, Washington, D. C., of counsel, for defendants.
In this proceeding American Home Products Corporation, on behalf of its Wyeth Laboratories' division ("Wyeth"), moved for leave to file an amended complaint requesting declaratory and injunctive relief prohibiting the Commissioner of Food and Drugs ("the Commissioner") from withdrawing certification of Wycillin SM-600,1 one of Wyeth's fixed combination antibiotic drugs.
This case was last before this Court in the summer of 1969. The manner in which this action originally arose, the narrow issue then involved and the relief afforded is set forth in American Home Products Corp. v. Finch, 303 F. Supp. 448 (D.Del.1969). Thus the historical background of this litigation need not be repeated in its full detail here.2
This controversy stems from the 1962 amendments to the Federal Food, Drug and Cosmetic Act ("the Act"), 21 U.S.C. § 301 et seq., which for the first time, required manufacturers of all drugs marketed in the United States to prove their products effective for the use intended.3 At the request of the Food and Drug Administration ("FDA") extensive drug efficacy studies were undertaken between 1966 and 1968 by the National Academy of Science—National Research Council ("the "NAS/NRC") to evaluate the manufacturers' claims of effectiveness for all drugs approved for marketing after 1938. The NAS/NRC reported to the FDA in September 1968 that a number of Wyeth's fixed combination antibiotic drugs, including Wycillin SM-600, were "ineffective as fixed combinations." On April 2, 1969, the Commissioner sent a copy of the appropriate NAS/NRC report to Wyeth and caused to be published in the Federal Register (34 Fed.Reg. 6006-6007) a notice of intention to amend the appropriate FDA regulations to delete certain of Wyeth's fixed combination antibiotic drugs from the list of drugs acceptable for certification pursuant to section 507 of the Act, 21 U.S.C. § 357. The notice stated that the Commissioner "concurred" in the findings of the NAS/NRC that certain of Wyeth's drugs were "ineffective" or "ineffective as fixed combinations" and that there was a lack of substantial evidence to support the efficacy claims of these combinations. The notice invited Wyeth to submit any additional "pertinent data."
On May 1, 1969, Wyeth submitted what it then believed to be "pertinent data" and requested a hearing. On June 13, 1969, the Commissioner caused orders to be published in the Federal Register (34 Fed.Reg. 9333-9338) deleting Wyeth's fixed combination antibiotic drugs from the list of drugs eligible for certification, prohibiting all further certification, and revoking previously issued certificates. The reason stated by the Commissioner for these actions was that Wyeth's May 1, 1969 submission did not contain any "new clinical data" and did not "provide substantial evidence of the effectiveness of such combination drugs." The June 13, 1969 orders provided that objections could be submitted and a hearing requested within thirty days, but that withdrawal of the products from the market had to be accomplished within forty days. The orders also required that a statement setting forth reasonable grounds for a hearing be filed and that it identify the claimed errors in the NAS/NRC evaluation and identify any adequate and well-controlled investigations from which it could reasonably be concluded that the fixed combination drugs would have the effectiveness claimed and would be safe for their intended use. Wyeth submitted objections on July 9, 1969, within the thirty day period, and again requested a hearing.
When the Commissioner failed or refused to rule upon Wyeth's objections and it was faced with the immediate removal of the drugs from the market, Wyeth filed this action requesting declaratory and injunctive relief. After several hearings, this Court, on August 18, 1969, enjoined the defendants from further proceeding against Wyeth's fixed combination antibiotic products until thirty days after the date the Commissioner completed action on Wyeth's objections and request for a hearing. American Home Products Corp. v. Finch, supra, 303 F.Supp. at 456-457.4
Following this decision, several significant developments occurred. On September 19, 1969, the Commissioner promulgated general regulations ("the September regulations") designed to facilitate the implementation of the NAS/NRC effectiveness review. 34 Fed.Reg. 14596. These regulations for the first time described in detail the kind of evidence that the FDA would deem necessary in order to meet the requirements of "substantial evidence" of effectiveness as that term was defined in section 505(d) of the Act, 21 U.S.C. § 355(d), applicable to non-antibiotic drugs, subject to section 505, and to certain antibiotic drugs, subject to section 507(h), 21 U.S.C. § 357(h). Pursuant to the authority granted under section 507(a) and (b) and delegated to him by 21 CFR § 2.120(a), the Commissioner promulgated regulations to insure the "efficacy of use" of drugs, such as Wycillin SM-600, subject to section 507(a) of the Act, 21 U.S.C. § 357(a), by ordering that the same efficacy standards applicable to drugs subject to sections 505 and 507(h) be made applicable to drugs subject to section 507(a).5 34 Fed.Reg. at 14597.
The September regulations defined "substantial evidence" solely in terms of "adequate and well-controlled clinical investigations", spelled out the criteria for such investigations, and dismissed as irrelevant other clinical evidence. Further, the drug manufacturer affected was required to show reasonable grounds for a hearing by presenting studies to the FDA which fully met the criteria for adequate and well-controlled investigations of the kind set forth in the regulations. 34 Fed.Reg. at 14597.
In Pharmaceutical Manufacturers Association v. Finch, 307 F.Supp. 858 (D. Del.1970) this Court rejected the Commissioner's characterization of the September regulations as "interpretative" and, because of their pervasive and substantial impact upon the drug industry, held the September regulations invalid on the ground that, contrary to the requirements of section 4 of the Administrative Procedure Act, 5 U.S.C. § 553, they were issued without the required notice of proposed rule making and opportunity for interested persons to comment.
In response to this decision, the Commissioner on February 17, 1970 published a notice of proposed regulations ("the February proposals") and invited comment by interested parties. 35 Fed.Reg. 3073. The February proposals were similar in material content to the September regulations.
After considering the various comments submitted by interested parties, the Commissioner on May 8, 1970, published in the Federal Register a statement discussing and disposing of the comments, and an order setting forth the final regulations ("the May regulations"), which became effective upon publication. 35 Fed.Reg. 7250; codified in 21 CFR, parts 130 and 146. The May regulations again made the same standards of "substantial evidence" of effectiveness applicable to drugs subject to section 507(a) as were applicable to drugs subject to section 505 and section 507(h). 35 Fed.Reg. at 7253; codified as 21 CFR § 146.1(g) (1) and (2).
By delineating the scientific content necessary for "adequate and well-controlled clinical investigations", the May regulations established standards of evidence which the FDA deemed necessary in order for a manufacturer to demonstrate the effectiveness of drug products, including drugs such as Wycillin SM-600, subject to the "efficacy of use" requirement of section 507(a). See 35 Fed.Reg. at 7251-7252; codified in 21 CFR § 130.12(a) (5) (ii). The May regulations also set forth the procedural requirements for obtaining an evidentiary hearing when the Commissioner proposed to amend or repeal an antibiotic certification regulation on efficacy grounds. 35 Fed.Reg. at 7252; codified as 21 CFR § 146.1(d). The Commissioner's authority to issue the May regulations, when challenged in this Court by the Pharmaceutical Manufacturers Association, was upheld. Pharmaceutical Manufacturers Association v. Richardson, 318 F.Supp. 301 (D.Del.1970).
During the time that the Pharmaceutical Manufacturers Association litigation was proceeding in this Court, the August 18, 1969 preliminary injunction issued in this case remained in effect. The Commissioner continued to review Wyeth's objections and consider its request for a hearing with respect to its fixed combination antibiotic drugs. A change occurred during 1970, however, when Wyeth voluntarily ceased the manufacture and sale of all of its fixed combination antibiotic drugs affected by the Commissioner's June 13, 1969 orders, except Wycillin SM-600. On or about June 3, 1970 Wyeth advised the FDA that these products were no longer being produced. At the same time Wyeth withdrew all its objections to the June 13, 1969 orders, except to the extent that those objections and the request for a hearing related to Wycillin SM-600.
On June 23, 1970, the present Commissioner published in the Federal Register (35 Fed.Reg. 10211) notices confirming each...
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