Law

            Preemption

            For those heartened by any expansion of the FDA’s express preemption of state law, a bit is included in the draft, also under Subtitle E.   Section 586E(c), on p. 391, provides, “No State shall require licensure as a wholesale device distributor or third-party logistics provider by any person or for any activity related to the manufacture, distribution, delivery, or dispensing of a device for which licensure is not required under section 586B or 586C, including the distribution of a device which is not a prescription device.”  Device distributors in particular should watch this little gem.

            There’s also preemption with respect to something called a “Medicaid children’s case coordination program” for “children with complex medical conditions.”  Section 1947(h), on page 339.  This is something that would primarily interest malpractice defense lawyers.

            Exemption of Certain Transfers from Sunshine Act

            Another potentially defense-friendly provision appears in Subtitle S – Continuing Medical Education Sunshine Exemption.  Section. 4881(a)(2), at p. 344-45, exempts from the Sunshine Act’s manufacture transparency requirement “a transfer of anything of value to a covered recipient who is a physician if the thing of value is intended solely for purposes of providing continuing medical education to the physician.”  The purest benefit of this provision is its incentive for drug and device manufacturers to support continuing education.  From a defense perspective, if Congress regards such transfers as sufficiently benign as not even to require transparency, then that could be a counter to plaintiffs’ insinuations.

            Safe Harbor for Off-Label Promotion?

            Finally, we may be grasping at straws, but we are encouraged by a heading that promises text “to be supplied.”  Subtitle H (page 92) is headed “Facilitating Responsible Communication of Scientific and Medical Developments.”  We hope this means the only thing we believe it can mean – that Congress is finally prepared to shelter communications about new treatments – by definition, “off-label,” because they are new – by providing a safe harbor for certain types of truthful communication about off-label promotion in the FDCA. We will keep you posted if and when the missing language is supplied.

            In a 400-page bill there is necessarily much, much, MUCH more, but we thought these promising nuggets were worthy of mention.  Because we slogged through the thing, you don’t have to.