In a failure-to-warn case arising out of the use of the prescription drugs, Elidel and Protopic, Judge Hood noted that the FDA’s position had been inconsistent, and concluded that, while “to the degree that the FDA seeks to address ambiguities in the FDCA or in its own regulations, we will give that opinion great weight. Where, however, the agency attempts to ‘supply, on Congress’s behalf, the clear legislative statement of intent required to overcome the presumption against preemption,’ no deference is warranted.” Then, looking to Sixth Circuit precedent, the court acknowledged that prescription drug failure-to-warn claims “premised on the adequacy of the warnings approved and reviewed by the FDA” would be preempted. However, “a state law requirement to provide an additional warning would not conflict with federal regulations.” The court recognized that “a manufacturer can add or strengthen a warning without FDA approval so long as the warning does not render the label misleading. 21 C.F.R. § 314.70(c)(2), 21 U.S.C. § 352(a). If the manufacturer obtains new evidence regarding a risk the FDA previously found unsubstantiated, the manufacturer may still inform the FDA and seek approval for a new label. 21 C.F.R. § 314.70(b). Finally, the regulations encourage drug manufacturers to periodically send important information, including information regarding risks, to healthcare providers. Id. § 200.5…. In this case, At the time Elidel was prescribed for Philip Weiss, the FDA had not made a conclusive finding regarding a link between the use of topical calcineurin inhibitors and increased cancer risk. In addition, NPC could conceivably have possessed information not available to the FDA that they could have communicated to the FDA, to healthcare providers, or to patients, consistent with FDA regulations. Finally, state law failure-to-warn claims would not disrupt the FDA’s regulatory scheme because FDA’s regulations specifically provide avenues by which pharmaceutical companies may strengthen warnings following approval of the original label.” Hence, the motion to dismiss was denied. See Weiss v. Fujisawa Pharmaceutical Co., No. 5:05-527, 2006 U.S.Dist.LEXIS 86179 (E.D.Ky. Nov. 28, 2006). [See also: In re Medtronic, No.05-MDL-1726, 2006 U.S. Dist. LEXIS 86199 (D.Minn. Nov. 28, 2006)(rejecting FDA preemption in MDA case).]