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We blogged about possibly interesting nuggets in the 21st Century Cures Act (“21CCA”) back in February, 2015 – when it was only 400 pages long.  In true congressional fashion, it’s now twice as long and loaded up with enough goodies (mostly of the $$$ variety) that it just passed the House of Representatives by a 392 to 26 margin.  It thus seems poised to become law.  Given the prospects for imminent passage, we decided to revisit this monster and see if there’s anything more of interest to product liability defendants.  We aren’t interested in the spending-related aspects of this bill, which are what’s really greasing its skids.

So here goes.


The first thing we wanted to see is if there is any preemption of civil lawsuits, so we searched the text of the bill for the word “state.” More than 100 matches.

We looked through them all and didn’t find any preemption provisions that could be useful in product liability litigation. Dry hole, that.

Off-Label Promotion and First Amendment Issues

However, some of the appearances of the word “state” did occur in sections of the 21CCA that were of interest for other reasons. The most promising material we found relates to our continuing interest in off-label promotion and the First Amendment.

One thing we’ve found is subtitle F, entitled “Facilitating Responsible Manufacturer Communications.” Our reading of the amendment to the FDCA’s definition of “false and misleading label” (21 U.S.C. §352(a)) looks like Congress is poised to legalize the provision by regulated manufacturers of some information about off-label uses to third-party payors, formulary committees and other entities that decide whether uses of drugs are reimbursable.  The off-label issue is addressed by disclaimers:  “a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug.”  21CCA §2101(4).  It doesn’t cover pure off-label promotion (§2101(5) – new §(2)(A)), but the connection of the information to on-label uses would no longer be limited by the phrase “directly relates.”

This legalization should get rid of some of the current TPP (as plaintiffs) litigation over purported “illegal” off-label drug promotion. More broadly, for First Amendment purposes, it demonstrates the feasibility of the disclaimer alternative to the FDA’s increasingly tattered flat ban.

Oddly, this new language applies only to “drugs” and does not mention devices. Device companies might want to complain to their senators (since it’s passed the House) about this disparate and unequal treatment.

As to off-label promotion generally, there’s this congressionally mandated deadline:

Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue draft guidance on facilitating the responsible dissemination of truthful and nonmisleading scientific and medical information not included in the approved labeling of drugs and devices.

21CCA §2102(a). The FDA has been dragging its feet on off-label promotion and the First Amendment literally for years.  Congress might not be able to decide what it wants to do, but it recognizes that something must be done, and soon, but why only “draft guidance”?   That’s not legally binding.  What the FDA needs to do is update and create new regulations.

Congress labored mightily and brought forth this mouse.

Another recurring issue in First Amendment/off-label promotion litigation is what replaces the FDA’s “substantial scientific evidence” (two double-blinded clinical trials) standard for truthful off-label promotion.  Defenders of the FDA’s ban raise the prospect of a slippery slope if anything less is considered not “false and misleading” for First Amendment purposes.

We recommend reviewing 21CCA §511 as an alternative. The 21CCA is proposing to allow new antibiotics and antifungals – to fight multi-drug resistant organisms, a major public health problem – be marketed with less than the FDA’s current scientific evidence floor behind them.  Since less restrictive alternatives are one aspect of First Amendment protection of commercial speech, it’s nice for Congress to provide advocates of truthful off-label promotion with such an alternative.

Sections 511(b)(2)(C), 511(b)(4), and 511(e)(2)(b) indicate how far down the slippery slope Congress is willing to go.

We point out that the 21CCA attempts to limit its jettisoning of the substantial evidence standard to these products, §511(g), but we doubt that the First Amendment, and particularly the “topic” analysis of Reed v. Town of Gilbert, 135 S. Ct. 2218 (2015), permits such content- and speaker-based discrimination.  Also there’s plenty of First Amendment authority (that we mentioned here) for the proposition that restrictions on speech that are shot full of holes and exceptions fail to “directly advance” purported governmental interests for the restrictions.  The 21CCA adds more such exceptions to and already porous prohibition.


Since plaintiffs love to impugn all payments that physicians receive from our clients, another useful provision of the 21CCA is §3041, which eliminates from federal “transparency” reporting a variety of payments made for continuing medical education (“CME”) purposes, under certain limited circumstances – CME “that does not commercially promote a covered drug, device, biological, or medical supply” and payment of “the tuition required to attend an educational event.”  It’s not a lot, but it’s something.

This section would support the argument that, since Congress explicitly exempts them from reporting, there’s nothing questionable about these types of payments.

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And that’s it. For an FDA-related bill that long, it’s pretty thin gruel.  Maybe our clients will fare better in the next Congress.