USV Pharmaceutical Corp. v. Richardson
USV Pharmaceutical Corp. v. Richardson
Opinion of the Court
Unlike the drug manufacturers in Ben-tex,
The threshold question raised by the defendants and overruled by the District Court may be quickly disposed of. Under similar circumstances in Bentex, we sustained the right of the District Court to entertain an action for declaratory judgment. We reach the same result here. Since we dismiss the claim of the plaintiff for exemption on behalf of its drugs on substantive grounds, it is unnecessary to consider the additional objection that plaintiff has failed to exhaust administrative remedies.
The substantive issue posed by this action is the right of the plaintiff to the exemption provided by section 107 (c) (4) from the revised definition of “new drug” incorporated in the 1962 Amendments. In resolving that issue, we must differentiate, even as the “grandfather clause” itself does, between the plaintiff’s drugs, which were covered by an “effective NDA”,
It is the contention of the plaintiff that all its drugs in question, both those previously NDA’d and those not, are protected by the permanent “grandfather clause” (i. e., Section 107(c) (4)). Because the statute seemingly makes a distinction between the two, it is proper to consider separately the two groups of drugs: i. e., those having NDAs and those without NDAs.
Taking up first plaintiff’s NDA’d drugs: There is no dispute that such drugs met criteria (A) and (B), as set forth in the “grandfather clause”, but the defendants seriously dispute the claim that they meet condition (C). Facially at least, this contention of the defendants seems unanswerable. These drugs are “covered by an effective application” or NDA, and are thus specifically barred by condition (C) from qualifying for exemption from the ap
The plaintiff, though, presses another theory upon the basis of which it claims the previously issued NDAs are to be regarded as ineffective on October 9, 1962. Thus it argues that its pre1962 NDA’d drugs became generally recognized as safe on or before October 9, 1962. So much the defendants seem to concede in the Stipulation of Facts submitted to the District Court. From this fact, it reasons that its NDA drugs ceased to be “new drugs” as defined in the Act, on or before October 9, 1962, and, ergo, its previously issued NDAs were no longer needed or “effective” on the critical date of October 9.
The plaintiff has, however, two drugs,
It is the contention of the FDA that an approved NDA covers not merely the marketing of the parent but also its “me-too” offsprings and for that reason the “me-too” drugs have been permitted to be marketed without an NDA. Accordingly, under this theory, the withdrawal of the approved NDA of the pioneer operates as a withdrawal of marketing rights for the “me-too”, unless the latter, either individually or in conjunction with its pioneer, provides substantial evidence o,f effectiveness. This view has, however, been severely criticized and with considerably reason. It is, as one critic has observed, “at variance with the uniform position it (FDA) has taken over the years with regard to the nature of NDAs.” This position, which is termed the “personal approach” holds that “Section 505 applies to drugs as individual articles, not as collective groups, and that each manufacturer of a new drug must file his own NDA.” This critic concludes with the observation that it is “an unjustifiable exercise in semantics to say that a drug legally marketed without an NDA was
That the policy of FDA has heretofore been contrary to the position now taken by it is further illustrated by the circumstances under which at least one of the “me-toos” of the plaintiff began marketing. Prior to marketing Bivam, one of its “me-toos” similar in formula to other drugs previously NDA’d by it, the plaintiff inquired of FDA whether it was an “old drug” entitled to be marketed without an NDA. FDA, after reviewing its composition and labeling, advised the plaintiff it was a product “generally regarded as safe” (and thus an “old drug”) and could be marketed without an NDA. There was no suggestion by the plaintiff that it sought to market this drug under any previous N DA granted one of its products nor did the FDA base its advice on that basis. Both the plaintiff and FDA assumed at that time that a “me-too”’ drug, which had become generally recognized as safe, was entitled to be marketed without an NDA; in short, that the qualification for marketing a “me-too” drug was general recognition of safety and not the NDA of its pioneer.
It would seem that the consistent construction of the Act by the FDA for thirty years
But even if it be assumed that “me-too” drugs are generally entitled to section 107(c) (4) protection, provided they were generally recognized as safe on October 9, 1962, that does not resolve the right of the plaintiff’s “me-toos” to exemption. As has been pointed out, the reasoning on which “me-toos” are regarded as not covered by the NDAs granted the manufacturers of their pioneers is that an NDA is regarded as “personal” to the manufacturer submitting the application and to the drug covered. But in this case, the “me-toos” are similar in formula and labeling to other drugs for which the plaintiff itself applied and obtained NDAs. It is true that, in the case of one drug at least, to which reference has already been made, plaintiff’s “me-toos” were regarded as exempt, not because plaintiff had an approved NDA for a similar drug,, but because FDA was of the opinion that it met the requirements for classification as an old drug. Nonetheless, it is the “personal” character of the NDA that has been deemed as the basis on which it is contended that the “me-toos” are not covered by the NDA granted another manufacturer, albeit the drugs involved may be similar. That reasoning manifestly cannot sustain a right of exemption in favor of plaintiff’s “me-toos”. The plaintiff’s NDAs, being “personal” to it, would cover all its products similar in formula, including those specifically described in its applications and all others like in
Reversed, with directions to enter judgment for the defendants.
Reversed.
. Bentex Pharmaceuticals, Inc. v. Richardson, 463 F.2d 363 (4th Cir., 1971).
. “Effective”, as used in this phrase, means simply approved. Hagan, Grandfather Protection Under the Drug Amendments of 1962, 19 Food Drug Cosm.L.X, 119, p. 121.
. This is the term used to describe an approved preclearance application under Section 355.
. “Substantial evidence” is defined in the Act (21 U.S.C. § 355(d)).
. Section 355(e), 21 U.S.C.
. Section 107(c) (3) (B), 21 U.S.C., note foil. Section 321.
. Note, Drug Efficacy and the 1962 Drug Amendments, 60 Georgetown L. Journal, 185 at p. 198, n. 77 (1971).
. See Barth, Following the NAS-NRC Effectiveness Review, What?, 22 Business Lawyer, 1185, 1187 (1967).
. Jarecki v. G. D. Searle & Co. (1961) 367 U.S. 303, 307, 81 S.Ct. 1579, 6 L.Ed.2d 859; Ginsberg & Sons v. Popkin (1932) 285 U.S. 204, 208, 52 S.Ct. 322, 76 L.Ed. 704.
. United States v. Allan Drug Corporation (10th Cir. 1966) 357 F.2d 713, 718, cert. denied 385 U.S. 899, 87 S.Ct. 203, 17 L.Ed.2d 131.
. Duo-C.V.P. with Vitamin K Capsules and Bivam.
. Stipulation of Facts, Number 17.
. A “me-too” drug is generally defined as “one which is equivalent to another, pioneer drug, which preceded it on the market.” Note, Drug Efficacy and the 1962 Drug Amendments, 60 Georgetown L. Journal, 185, at p. 198, n. 78 (1971).
. See, Note, Drug Efficacy and the 1962 Drug Amendments, 60 Georgetown L. Journal, 185, at p. 203 (1971) :
“Surely, me-too drugs never processed through the new drug procedures satis-
fy all the requirements of section 107 (e) (4).”
To tlie same effect is Hagan, Grandfather Protection Under the Drug Amendments of 1962, 19 Pood Drug Cosm.L.J., 119, at pp. 125-6; D’Andrade, The Effect of NAS-NRC Review on Me-Too and Post-’62 Drugs, 25 Food, Drug, Cosm.D.J., 330, 334 (1970).
. This, of course, is not the only inequity in the Amendments. There are other inequities, as FDA freely conceded at a House Healing before a Subcommittee of the Commission on Government Operations on Drug Efficacy, Part 2, 91st Cong., 1st Sess. (1969), pp. 384^5.
. Note, Drug Efficacy and the 1962 Drug Amendments, 60 Georgetown L. Journal, 185, at p. 203, n. Ill (1971).
. See, Hagan, supra., at p. 125:
“Furthermore, the concept that new drug clearance by one manufacturer affects the rights of subsequent manufacturers is inconsistent with the established doctrine that new drug clearance is personal to the applicant, and does not embrace the drug per se.”
. Cf., comment in Note, Drug Efficacy and the 1962 Drug Amendments, 60
Georgetown L. Journal 185, at pp. 206-7 (1971) :
“Ultimately the issue of the status of me-too drugs will have to be squarely faced, and the FDA interpretation of section 107(e) (4), holding that they follow the pioneer’s fate, should be repudiated by the courts. In that event the agency will undoubtedly ask Congress for new legislation to remedy the situation. In view of the obvious inequities in the present situation, this would seem to be the most desirable solution.”
Reference
- Full Case Name
- USV PHARMACEUTICAL CORPORATION v. Elliot L. RICHARDSON, Secretary of Health, Education, and Welfare, and Herbert L. Ley, Jr., Commissioner of Food and Drugs, Food and Drug Administration
- Cited By
- 10 cases
- Status
- Published