2 Citing briefs
Beaty et al v. Food and Drug Administration et al
REPLY to opposition to motion re MOTION for Summary Judgment on Counts I and III MOTION for Declaratory Judgment
Filed June 3, 2011
Indeed, as noted above, see supra at 18, the Secretary of Health and Human Services has thus far refused to make the certification contemplated by Section 804 of the FDCA that foreign drugs “pose no additional risk to the public’s health and safety.” 21 U.S.C. § 384(l)(1)(A). The government cannot seriously contend that foreign unapproved drugs like thiopental are indistinguishable from their FDA-approved counterparts and create no additional risk to patients to whom they might be administered.
Beaty et al v. Food and Drug Administration et al
REPLY to opposition to motion re MOTION to Dismiss and/or for Summary Judgment MOTION for Summary Judgment
Filed July 8, 2011
See, e.g., Dubois, 820 F.2d at 950-51; Clarke, 2011 WL 1045543, at *6-8; K&K, 1996 WL 183023, at *8. As evidence that FDA’s exercise of enforcement discretion under Section 381(a) is consistent with legislative intent, FDA explained that the enactment of 21 U.S.C. § 384 in 2000 and subsequent amendment of that provision in 2003, “ratified FDA’s exercise of enforcement discretion under the agency’s personal use policy.” Defs’ Opening Mem., at 23.