Wilson v. Pliva, Inc.’s Empirical Analysis

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1 federal appellate · 1 district ·

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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
   e.g. Bartlett v. MUTUAL PHARMACEUTICAL CO., INC.