Replies to post #101076 on Biotech Values

[zipjet]

Selected quotes from SvS:

In this case we consider the validity of a district court order, preliminarily enjoining approval by the Food and Drug Administration ("FDA") of a generic drug, that was issued at the behest of the manufacturer of the competing brand-name drug. We previously stayed the preliminary injunction pending our resolution of this appeal. Because we find plaintiff has not satisfied the standards for a preliminary injunction, and in particular has not shown a likelihood of success [332 U.S.App.D.C. 410] on the merits, we now vacate the injunction.


The FDA's determination of what is required to establish "sameness" for purposes of the Act rests on the "agency's evaluations of scientific data within its area of expertise," and hence is entitled to a "high level of deference" from this court.

Dr. Woodcock was the authorized decisionmaker for the agency on this matter,... and hers is the view to which the courts owe deference.

But under Chevron, courts are bound to uphold an agency interpretation as long as it is reasonable--regardless whether there may be other reasonable, or even more reasonable, views.

Serono contends that it will be irreparably injured if the FDA is not enjoined from approving Repronex, because it will suffer an unrecoverable loss of sales to Ferring. But even if such a loss does constitute irreparable injury, as the district court found and defendants dispute, see Serono Laboratories, 974 F.Supp. at 35, that injury must be weighed against the next factor--the extent to which an injunction will substantially injure the other party, Ferring. And that balance of harms results roughly in a draw. Whatever sales Serono will lose to Ferring in the absence of an injunction, Ferring will lose to Serono in the presence of one.

Neither we, nor the district judge, are scientists independently capable of assessing the validity of the agency's determination--beyond holding it to the standards of rationality required by the Administrative Procedure Act

For the foregoing reasons, we vacate the preliminary injunction entered by the district court and remand the case for further proceedings consistent with this opinion. Our opinion does not foreclose the possibility that at a trial on the merits, and upon a fuller record, Serono may be able to establish that there are grounds for overturning the grant of Repronex's ANDA. We hold only that upon the current record, Serono has failed to establish that it meets the criteria for the grant of a preliminary injunction.

[biomaven0]

Of interest is this nugget from the FDA in its response to the Citizen's Petition:

Based on current relevant scientific data and information and our scientific experience and
expertise, we conclude that it is not necessary to completely characterize all the different
polysaccharide sequences of enoxaparin. Our finding of sameness for enoxaparin is not based
solely on the equivalence in molecular weight, anti-Xa activity, and/or anti-Xa/anti-lla ratio. We
conclude that the five criteria described in section III provide suffcient information to demonstrate
active ingredient sameness. Such a showing demo

So that suggests to me that complete characterization is not a requirement here.

My own take is that the FDA has now provided a roadmap to approval, and at some point Teva will indeed be able to comply. But my guess is that their current attempt (unless they are very lucky) will be found to fall short, and they will need to try again - that would entail something like 2 years or longer before approval.

Peter