On New Years’ Eve, the FDA released an interesting, and unsettling, proposed guidance indicating that it has plans to go public with what are essentially regulatory guesses, based on what it calls “emerging signals” that might suggest medical device risks. The formal title of the proposed guidance is “Public Notification of Emerging Postmarket Medical Device Signals.” It’s not final, and there is currently open a 60-day comment period that closes March 4, 2016. Basically the FDA is proposing to make public statements about possible device risks (and can drugs be far behind?) if the “emerging signals” meet the following criteria of “proof” – quotation marks intended:
- the information represents a new,potentially causal association, or a new aspect of a known association (e.g., increased rate or severity of event or reduced benefit), between a medical device and one or more adverse events or clinical outcomes;
- the available information is reliable and supported by sufficient strength of evidence; and
- the information could have important clinical implications for patient management decisions and/or could it significantly alter the known benefit-risk profile of the device.
Proposed Guidance at 6 (emphasis added). The guidance cautions, however, that such “information has not been fully analyzed, validated or confirmed, and . . . the Agency does not yet have specific recommendations.” Id. at 4. Further, the communications that the FDA is proposing “may lack certainty about the significance of the information.” Id.
Let’s unpack that a bit. These statements are internally – and we would say fatally – contradictory. How can risk data that “has not been fully analyzed, validated or confirmed” nonetheless be “reliable and supported by sufficient strength of evidence”? It can’t, not under any standard articulated under either the FDCA or FDA regulations, which is why the draft relies on no articulable regulatory standard but rather a dozen bullet point “factors.” Id.at 5-6.
That unvetted and unconfirmed information can nevertheless be “reliable” and of “sufficient strength” to do anything makes ourDaubert-acclimated heads spin. It’s like Schrodinger’s cat being alive and dead at the same time. But this is real-world public health, not a quantum mechanical thought experiment. In lay terms, the FDA is proposing to take regulatory shots in the dark based on preliminary information that is admittedly scientifically unverified and which the Agency can’t even say is significant. The Agency knows that there are risks that some of its shots will go off half-cocked:
We also recognize the potential unintended consequences of public communication about emerging signals, prior to confirmation and full evaluation of the data, including the possibility that a beneficial device’s use may be avoided or inappropriately stopped because of uncertain or unproven risks or uncertainty around the benefits.
Id. at 5.
We’re litigators, not regulatory experts, so our view of the “unintended consequences” of this proposed FDA guesswork is a little different. We expect that premature FDA announcement of unconfirmed potential device risks will lead to: (1) additional frivolous litigation, generated by lawyer solicitation and advertising that will surely lack any of the disclaimers mentioned by the FDA; (2) companies being burdened with inquiries from both medical and lay people about potential risks, which have little basis and about which the companies might not even know ahead of time, since the proposed guidance does not even mention, let alone mandate, prior consultation with the affected device manufacturer; (3) artificial spikes in adverse event reporting – confounding future risk assessment – because the spikes will be caused by the FDA, rather than by the actual risk, and (4) a regulatory “Catch-22” where the FDA is presuming to make announcements about purported “risks” where the data is too uncertain for regulated companies to support labeling changes. These are in addition to the potential adverse impact on patient care that the FDA’s proposal admits is there.
The FDA is supposed to be protecting the public health. In doing that, the benefits of medical devices are of equal importance as their risks. Beneficial products should be made available, not just risky products prevented. Yet the FDA is proposing to announce unverified and speculative risk information only – not benefit information of similar (in)significance. Not only is the agency proposing shots in the dark, it is proposing to do so in an entirely unbalanced fashion.
We also have two other specific comments about this proposal.
First, the FDA’s standards for what actually goes into device labeling – requiring “reasonable evidence of an association” even though a “causal relationship need not have been proved” – is already well below the standard of proof that a plaintiff must prove at a civil trial, as we discussed at length here. That’s okay as far as it goes, because administrative agencies like the FDA can act prophylactically and aren’t bound by legal standards of proof. However, this latest proposal goes deep into the realm of speculation, predictions, and involves admittedly unconfirmed information.
Thus, we think it would not be too much to ask that the FDA ameliorate its proposed actions – which will be inevitably exploited by the other side in litigation solicitation – by specifying that any agency “emerging risk” statements are not admissible for any purpose in civil proceedings. There’s precedent for the FDA doing this; it has prohibited discovery of the identities of persons reporting adverse drug and device reactions, which we discussed here, because preemption was involved. This is a similar situation. All of the drawbacks that the FDA has already acknowledged (see above) will be exacerbated if plaintiffs are allowed to admit such speculative FDA communications as evidence of notice, causation, duty to test, or generalized reptilian-trial tactics hysteria.
The second point we’d like to make is that what’s sauce for the goose is sauce for the gander. The FDA can’t arrogate to itself the exclusive authority to provide public information about device safety under the loose standard being proposed. If it’s okay for the government to speak – with all the caveats that the FDA specifies in Appendix A to its proposed guidance – about “specific information on the known benefits and risks of the device and its use,” Proposed Guidance at 7, then regulated entities and other stakeholders must have a similar right to speak. Yes, we’re talking about the First Amendment and off-label promotion. One of the interesting issues involving off-label promotion is how far below the FDA’s “substantial evidence” (two controlled studies) standard may scientific support for truthful off-label promotion go before the science gets too weak to be reliable. We’re not sure where that is, but if the FDA is proposing to take it on itself to provide public information on preliminary data, then we doubt that courts will look kindly on it trying to shut down similarly supported (or unsupported, as the case may be) speech on off-label uses by the entities it regulates.
So if the FDA presumes to make public statements on the basis of the slim evidence it describes in this proposed guidance, it should expect that the same rules will apply to other speakers under the First Amendment.