Replies to post #101635 on Biotech Values

[mouton29]

<<As biomaven noted in a prior thread, the intent of this provision in Hatch-Waxman Section 505(j) is to facilitate rather than hinder FDA approval of generic drugs. Thus, this H-W provision could have formed a basis for NVS/MNTA to have sued the FDA if their ANDA had been rejected on the basis on immunogenicity. >>

I don't see a post by Biomaven on the purpose of Hatch-Waxman (that may be my ineptness with the search function) However, what the SNY reply brief argues is that there is a balancing in Hatch-Waxman between facilitating generic drugs and inducing brand name pharmaceutical firms to develop new drugs. If the drug can be shown with limited statutorily specified types of data to be identical to the pioneer drug, then the FDA under 505(j) can find the generic to be the equivalent and substitutable and can approve on that basis. But the FDA could not, for example require a phase III trial under 505(j), if the data requires that kind of trial, approval should be under some other provision and in such case, unless I am mistaken, the generic would not be automatically substitutable.

I do see this post by biomaven:

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=52739468, where he said:

But I do think their basic argument is specious. Preclinical immunogenicity data can be reviewed independently from Sanofi's data file. And certainly the FDA has the right to review safety as it sees fit. For example, they could review excipients in a generic drug that were different from those used in the original drug.

Based on their reply memo, SNY would concede that the FDA has the "right to review safety" data. Their subtle (sophistical?) counter is that the while the FDA can review such data if voluntarily submitted, if such data is not volunteered by the applicant, the FDA cannot, under 505(j)(2)(A), REQUIRE it because it is not enumerated in clauses (i) - (viii). In the end, I find this argument bogus and I am with you that the court will not find for SNY.