We opposed the FDA’s ill-advised 2013 proposal to revamp the process for changing generic drug labeling from the outset. We had legal objections – that an FDA regulation could not alter the statutory “sameness” requirement imposed on generic labeling. We had practical objections – that the change was a sop to the plaintiffs’ bar, intended primarily to reduce generic preemption in civil litigation, rather than to pursue any legitimate FDA objective. And we had procedural objections – that FDA had secretly colluded with the plaintiffs’ bar in coming up with the proposal.
We were hardly the only ones to object, and the proposal was repeatedly deferred. Once the proposal was postponed until after the 2016 election, we pronounced it dead. Either the Ds would win, and approach the preemption issue directly by changing the makeup of the Supreme Court (Mensing/Bartlett were 5-4 decisions), or the Rs would win and the FDA would stop carrying water for the plaintiffs’ bar.
The latter happened, with [fill in the blank] consequences for the country and the world, but with predictable consequences for the FDA’s generic labeling proposal. After a reasonable interval, the FDA formally put an end to the lingering 2013 proposal last week. Here is the bottom line, from a December 13 statement posted on the FDA’s website:
In November 2013, the FDA proposed a rule . . ., which, if finalized, would have allowed generic drug makers to independently – meaning, without prior FDA review and approval – update and promptly distribute new safety information in drug labels. This is something that currently only branded drug makers can do.
This rule, if implemented, would have allowed generic manufacturers to independently update their drug labels with new information. We heard from manufacturers that they believed this change would have imposed on them significant new . . . liabilities. We heard arguments that the proposed rule could impose new costs on generic manufacturers that might have raised the price of generic drugs. . . . And, among other challenges, the new policy would have resulted in labels for the same drug that varied between different generic manufacturers, for some period of time. This could have led to consumer and provider confusion.
Today, the FDA is withdrawing this proposed rule. . . .
Dick Tracy signing off! The bottom line is that, after five years, nothing has changed, particularly the scope of and basis for generic preemption. Nor will there be any change to the FDA’s requirement of agency preapproval to changes to the “highlights” section of branded drug labeling – another potential source of preemption in civil litigation (this isn’t mentioned in the FDA statement, but is discussed in the accompanying Federal Register notice).
This agency coup de grâce is accompanied by the usual regulatory word salad about “ensur[ing] that generic companies continue to engage in an appropriate level of post-market safety surveillance” and “hurdles that – if the rule was implemented – could compromise public health.” The FDA admitted:
[A]dditional or different warnings [could] temporarily appear in generic drug labeling compared to the brand drug – depending on the availability of information to various manufacturers and the timing of updates. Such differences, even if temporary, could undermine confidence in generic drugs and their therapeutic equivalence. We understand that the proposed rule may have also led to confusing, conflicting generic labels that were crowded with redundant safety information. Individual generic manufacturers might have added additional and at times superfluous information to their individual labels to avoid the risk of liability for failure to warn.
This, of course, is a problem hardly limited to generic drugs. Competing branded drugs have all of these issues, too, which is one reason that the FDA frequently imposes class-wide labeling. There’s a solution for it – called “Expedited Agency Review” (“EAR”) – that would involve the FDA at an earlier stage in all labeling changes to ensure that this kind of chaos from occurring. EAR was proposed as an alternative to the 2013 proposal, but is not mentioned in the FDA’s statement, probably because it would require “additional resources and help from Congress.”
The FDA’s statement does contain a useful clarification of the responsibility for labeling changes, after a branded “reference listed drug” is withdrawn from the market:
If the brand drug manufacturer has voluntarily withdrawn their marketing application, generics that reference the brand medicine can still be approved and marketed. But the brand drug manufacturer is no longer responsible for making any necessary label updates that generic applicants can follow.
See also Federal Register Notice. We add emphasis to this statement, since today is also the first anniversary of T.H. v. Novartis Pharmaceuticals Corp., 407 P.3d 18 (Cal. 2017), a case in which the California Supreme Court failed to recognize this basic fact.
More information on the withdrawal of the FDA’s 2013 generic labeling proposal is available at 83 Fed. Reg. 64299 (FDA Dec. 14, 2018)