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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.

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.

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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