Biotech Values

[mouton29]

<<While the FDA had every reason to 'do the right thing' it seems the Law might be saying something else.>>

You need to check the cross reference in clause (vii) and also read (j)(4). These appear to be the key provisions the FDA relies on:

505(b)(1)(D) [the appplicant shall submit] a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug

and

505(j)(4) Subject to paragraph (5), the Secretary shall approve an application for a drug unless the Secretary finds—
(A) the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the drug are inadequate to assure and preserve its identity, strength, quality, and purity

The FDA's argument -- which is nicely set forth in the first few pages of their surreply -- is that these two clauses give them the power --indeed obligation - to assure themselves of the drug's purity and that the immunogenicity testing was a means to that end.

SNY's argument is that this is backdoor safety testing, which the statute does not permit. Also, that clause b(1)(D) requires the applicant to describe its manufacturing process, it does not allow the FDA to require tests analyzing the effects of such processes. Also, that the case law (especially Serono Laboratories v. Shalala (158 F.3d 1313 (Court of Appeals Dist Col. 1998) http://cases.justia.com/us-court-of-appeals/F3/158/1313/544860/ ) may permit the FDA to consider such information as immunogenicity testing if voluntarily submitted by the applicant, but does not permit the FDA to require such testing.

The FDA response is that while full blown safety trials cannot be required, so that the FDA could not require a randomized trial to ascertain the safety of the purportedly identical active ingredient, but instead must rely on the pioneer's safety data, it can require narrow testing of the type required here under its power to assure purity.

Put another way, as I understand SNY's argument, if the manufacturing description included the statement "we don't permit rusty nails to fall into our drugs" but the sample furnished the FDA had a rusty nail in one of the vials, the FDA could not require the applicant to perform a test demonstrating the drug was free of rust. The FDA could encourage, hope and pray that the applicant would provide the testing, but could not require it or fail to approve the application absent the test.