We wanted to draw your attention to a draft bill recently released by House Republicans, proposing amendments and overhauls of numerous FDCA provisions. It is a monster – 400 pages long – and you can read it here. Here is the summary that accompanied the draft. We haven’t seen anything looking at this bill through the lens of litigation, and we thought we would. Several potentially defense-friendly provisions caught our attention:
Definition of Prescription Medical Device
Title V of the draft is entitled “Modernizing Medical Product Regulation.” Subtitle E under this title, “Supply Chain Security for Devices,” includes, for the first time in an FDCA provision, a definition of “Prescription Medical Device.” Section 586(7), at page 370, provides that a “prescription device” is a restricted device which “which, because of any potentiality for harmful effect, the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device” and “for which the Secretary has determined adequate directions for use cannot be prepared” and which therefore must a carry a designation that it is for physician- or dentist-use only, “or a statement that Federal law restricts the device to sale by or on the order of a licensed health care practitioner.” How something becomes “prescription only” is one of those FDCA basics that has always struck us as needlessly complex to explain. This definition does a good job of that.
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.