Mensing v. Wyeth, Inc.’s Empirical Analysis

Citation profile

3 federal appellate · 5 district ·

Most-quoted passages

The sentences later courts lift from this opinion, ranked by how many decisions quote each — the parts of the opinion doing the work. These counts are smaller than the citation total above because most of the 17 citing decisions cite the case generally; a passage count includes only decisions quoting that exact language verbatim.

1. “are subject to the labeling requirements” set forth at 21 C.F.R. § 201.80 , see note 13, supra, the defendants argue that the rule "does not mean ANDAs are subject to the requirements in § 201.80; it means that any NDA drug first-approved before June 2001 is subject to the regulation.” The defendants do not explain, though, how an ANDA-approved drug is anything other than a "[prescription drug product[ ] not described in paragraph (b)(1).” So the court rejects their interpretation. 29 . In proposing the regulations, the FDA noted that it would “not accept ANDA's for products with significant changes in labeling,” on the theory that those might be necessitated by other kinds of differences from the listed drug that would "jeopardize the safe or effective use of the product.” 54 Fed.Reg. at 28885 (emphasis added). 30 . To like effect is the FDA's remark, in response to a comment on 21 C.F.R. § 314.127 (a)(7), that it had "revised § 314.150 to require ANDA holders to maintain current labeling.” 57 Fed.Reg. at 17968. 31 . The remarks do note that § 314.150 "permitís] the agency to withdraw approval of the ANDA if the applicant fails to maintain labeling in compliance with the requirements of the Act,”

   1 later decision quote this exact passage · from the majority
   e.g. Bartlett v. MUTUAL PHARMACEUTICAL CO., INC.

2. “Although [ 21 C.F.R. § 314.97 ] contains a provision requiring [ANDA] applicants to ‘comply with the requirements of § 314.70 ... ’ that provision does not modify the requirement that the drug label for a generic drug must be the same as the label for the approved innovator drug ... Any ambiguity in the regulatory text has been clarified by FDA, which explained at the time of the promulgation that the regulations do not authorize drug manufacturers to add new warnings to the approved labeling for the innovator drug. See 57 Fed. Reg. at 17961, 17953, 17955.”

   1 later decision quote this exact passage · from the majority
   e.g. 586 F. Supp. 2d 642 - Demahy v. Wyeth Inc.