As such, there is no relevant factual dispute providing a basis on which to grant a hearing. Further, FDA regulations clearly state that hearings will not be granted on issues of policy and law under 21 C.F.R. § 12.24(b)(1).Given PMRS’s litigation track record, this probably isn’t the last FDA or the courts will hear from them.

FDA’s 54-page Proposed Order deals (in one way or another) with each issue raised in comments, and concludes:[T]the Commissioner finds that the PEG 3350 ANDA holders have failed to raise a genuine and substantial issue of fact requiring a hearing in their responses to the NOOH. A hearing, therefore, is not required under 21 CFR 12.24(b). The PEG 3350 ANDA holders submitted anecdotal evidence to support their factual assertions and did not submit any specifically identified reliable evidence demonstrating that a hearing is necessary.