Biotech Values

[Mpower]

MNTA Opinion on PI

First a point of clarification, for the confused.
FDA SEC. "505" = "21 USC 355".

Mouton, I agree with you that the Judge cited 355(j)(2)(A)(vi) as justification. However, I respectfully disagree with your assertion that the holding was not justified under the bioequivalence clause 355(j)(2)(a)(iv). The thrust of the courts opinion is that clauses (355)(j)(2)(A)(i)-(viii) are "sufficiently broad" and "provide the FDA with ample discretion to evaluate an ANDA."

Please note the following on page 15-16 of the opinion....


"Sanofi argues that this case should be resolved under Chevron step one because § 355(j)(2)(A) “unambiguously prohibits FDA from requiring an ANDA applicant to conduct basic safety testing such as immunogenicity testing.” Pl.’s Reply Br. at 5. While it is undoubtedly true that the FDA may not require an ANDA applicant to submit information beyond what is specified in § 355(j)(2)(A)(i)-(viii), the FDA persuasively counters that “the categories of required information are set forth in broad, general terms that provide FDA with ample discretion to determine what information it may assess to evaluate an ANDA.” Fed. Defs.’ Surreply at 4; see also Serono, 158 F.3d at 1324 (“[T]he clauses [in § 355(j)(2)(A)(i)-(viii)] simply describe what the ‘information’ in an application must ‘show.’ They do not specify the kinds of studies that can or cannot be used to satisfy the requirement[s].”). This Court agrees."

The main thrust of the original post I referenced was: "The Sanofi suit alleges that FDC Act § 505(j)(2)(A)“specifically precludes FDA from requiring the submission of such [safety and effectiveness] information." This is NOT true. "

The opinion is consistent with what I stated above.... reliance on (j)(2)(A)(iv) vs. (j)(2)(A)(vi) is IMHO immaterial.

(My original post is at http://investorshub.advfn.com/boards/read_msg.aspx?message_id=52744625)