Wow, ChromaDex on Tuesday filed a supplement to its FDA petition, and it's a doozie! You can read the supplemental petition here:
The petition itself is clear and compelling -- I really do encourage you to read it -- but there is still a lot for us to unpack. First,
Welcome King & Spalding
A warm welcome to ChromaDex's newest law firm, King & Spalding. Until now, Cooley has been handling ChromaDex's commercial litigation, and Steptoe has been patent counsel. Cooley and Steptoe are first-rate firms, and they have been doing great work. King & Spalding is of the same very high calibre.
However, King & Spalding is here no doubt because one of their partners, Sheldon Bradshaw, is an FDA specialist -- and not just any FDA specialist: Former Chief Counsel to the FDA. So he knows what he is talking about. And you will see in this supplemental petition that when a specialist comes onto the field, it's a thing of beauty. This is world-class lawyering.
Okay, let's cut to the chase:
ChromaDex's supplemental argument is this:
1. The whole reason that Congress and the FDA created these regulatory processes is because they are necessary and important to protect the public
2. Elysium's behavior in general, and its response to ChromaDex's FDA petition in particular, appears to flout the regulatory requirements
3. The FDA has specifically stated that it wants to reward good citizenship and to discourage companies from ignoring these requirements
4. If the FDA does not respond to Elysium's behavior, then it will be undercutting its own legal processes
What's really great about this petition is that it is chock full of footnotes quoting the FDA's own statements asserting that it cares about the processes that ChromaDex is trying to vindicate.
The way you win as a lawyer is by convincing the decision-maker that they already decided the case; now they just need to act. I find the supplemental petition extremely convincing in this respect, and I think the FDA will, too.
SDNY Implications
We will go into the details of the argument in a moment, but first let's consider the effect that this petition has on the litigation in the Southern District of New York.
ChromaDex filed its original FDA petition on August 18, 2017. Elysium responded with a public comment filed on September 22, and then with a complaint in federal court on September 27 arguing that the FDA petition was a "sham" that was only intended to harm Elysium and could not reasonably have been expected to have been acted upon by the FDA.
The "sham" issue was important, because ChromaDex has a First Amendment right to petition the FDA. Elysium's lawsuit needs to establish that ChromaDex was not REALLY petitioning the FDA, or else the lawsuit would be thrown out based on Noerr-Pennington immunity.
We predicted here that Noerr-Pennington immunity applied, and that Elysium's complaint would be dismissed, but Judge Caproni has not yet ruled on ChromaDex's motion to dismiss Elysium's complaint.
ChromaDex's new supplementary petition will not directly affect the SDNY litigation, but it sheds a great deal of light on whether the original petition was a sham petition or not. In fact, the supplemental filing absolutely destroys the notion that the ChromaDex does not and cannot expect the FDA to act. So, although I already expected that the SDNY would dismiss Elysium's New York claims, I would now be shocked and astounded if Judge Caproni found that ChromaDex had done something wrong by filing its citizen petition. Why? Because...
The Supplemental Petition
The entire purpose of the supplemental petition is to request EVEN MORE action from the FDA than was requested in the original petition.
The original petition, you will recall, requested that the FDA (1) determine that New Basis is adulterated, and (2) determine that New Basis is being sold without an NDIN.
Now, in addition, ChromaDex requests that the FDA:
(1) Publicly state that the guidelines addressing residual solvents in drugs do not apply to dietary supplements;
(2) Determine that nicotinamide riboside chloride is not reasonably expected to be safe if it contains new impurities such as toluene that were not included in the toxicology studies conducted to establish its safety; and
(3) Finalize the FDA's 2016 draft guidance that the FDA will prioritize enforcement of the NDIN requirement in circumstances where a dietary supplement manufacturer has complied with the law, but other manufacturers continue to distribute products containing the same New Dietary Ingredient without complying with that law.
In other words, ChromaDex says to the FDA, we are following your rules. Are those rules real? We are asking because...
...In its comment, Elysium did not deny that it failed to file an NDIN for NR. Elysium did not attempt to justify its violation of the FD&C Act or assure FDA that it is planning to comply with the Act. Moreover, Elysium did not deny that Basis contains toluene in measurable levels, as shown in the laboratory report filed with FDA, nor did Elysium promise to remove toluene from its product.
Instead, Elysium suggested that the presence of toluene in dietary supplements is acceptable due to guidelines that do not apply to dietary supplements. The guidelines cited by Elysium...outline prohibitions relating to the presence of residual solvents in drug manufacturing...
Elysium's response is alarming because it appears that Elysium (1) is willfully disregarding the NDIN requirement established in Section 413(a)(2) of the FD&C Act...and (2) is not making any attempt to remove toluene from its product.
ChromaDex argues that "Elysium's willingness to ignore this issue...should be a wake-up call for FDA. If the FDA does not prioritize enforcement in this area, then the NDIN requirement will become a dead letter in the law."
ChromaDex then marshals this kind of evidence to suggest that the FDA actually does care about this kind of thing:
1. In 2016, an FDA official was quoted in a journal article as saying, "The NDI notification process is very important to the FDA. The notification process is FDA's only premarket opportunity to review products, to review the formulation and the safety of products, and we take that seriously."
2. An FDA compliance policy guideline governing drugs notes that the FDA will take enforcement action against unapproved drugs when one provider has followed the drug approval process and other providers have not.
3. Draft industry guidance states that each manufacturer must submit its own NDIN; Elysium can't rely on ChromaDex's NDIN. "In fact," says ChromaDex, "this situation reveals precisely why a separate notification is needed." ChromaDex's NDIN highlighted manufacturing controls that precluded the use of toluene, whereas Elysium's manufacturing process obviously does not have the same controls that were part of the approved NDIN.
Conclusion
We are still more interesting in the outcomes of the litigations before the SDNY, PTAB, and the CDCal than we are in how the FDA responds to ChromaDex's citizen petition.
However, this supplemental response may impact what goes on in New York, and certainly illustrates the general strength of ChromaDex's position, as well as ChromaDex's competence at asserting its legal position.