FDA Proposes a Rule that Would Undercut Generic Drug Preemption

By Jennifer M. Thomas –

The generic drug industry has waited with bated breath since, as we reported here and here, FDA signaled that it was “considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances.”  See Amicus Brief of the United States at 15, n. 2, Mutual Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013) (No. 12-142).  On Friday, November 8, 2013, the wait was over.

FDA’s Proposed Rule would allow generic manufacturers to independently update product labeling through the “changes being effected” (“CBE-0”) supplement process that is currently only available to branded drug manufacturers with respect to product safety labeling.  Under the Proposed Rule, generic manufacturers could unilaterally change their safety-related product labeling, and those changes could take effect simultaneous with the companies’ notification of FDA and of the branded drug manufacturer – no prior approval required.

The current regulatory scheme only permits generic manufacturers to use CBE-0 to update their labels in conformance with the branded drug (also called the Reference Listed Drug, or “RLD”) label.  See 21 C.F.R. § 314.150(b)(10).  Practically speaking, this means that the branded drug manufacturer must change its labels first, followed by the generics.  Most importantly, the Supreme Court has determined that generic manufacturers’ lack of independence with respect to drug safety labeling makes it impossible for them to comply with both Federal drug labeling requirements, and state tort law (failure to warn or design defect) requirements.  See PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011); Mutual Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013) (reasoning that the only way to correct a design defect with respect to a drug that cannot be reformulated is through labeling).  Thus, state product liability suits based on use of generic drugs have generally been held preempted by Federal law.  Id.

While FDA’s stated purpose in proposing the new rule is to “speed the dissemination of new safety information about generic drugs to health professionals and patients,” (FDA Press Release), it is no mistake that the first whisperings of this rule appeared in a case involving generic preemption.  FDA’s admission that “[i]f this proposed regulatory change is adopted, it may eliminate the preemption of certain failure-to-warn claims with respect to generic drugs,” seems a ridiculous understatement.  If finalized, this rule would change the entire regulatory and liability landscape for generic drug manufacturers.

But does FDA have the authority to promulgate the Proposed Rule?  And if so, should it?  Given the serious questions surrounding it, this Proposed Rule seems as likely to go the way of the dodo as to ultimately be finalized.

Concerns about FDA’s statutory authority are unavoidable.  FDA acknowledges that its proposed new regulatory scheme would result in at least a temporary multiplicity of labels for the “same” drug, a result that the statute appears to prohibit except in enumerated circumstances.  See 21 U.S.C. § 355(j)(2)(A)(v).  Specifically, the statute requires applicants for generic drug approval to provide “information to show that the labeling proposed for the new drug is the same as the labeling approved for the listed drug . . . except for changes required because of difference approved under a [suitability petition], or because the new drug and the listed drug are produced or distributed by different manufacturers.”  Id.; see also id. at § 355(j)(2)(C).

FDA’s Federal Register notice wisely avoids addressing the statutory “sameness” point directly.  However, it does note that by waiting to actually approve a safety-related CBE-0 supplement until FDA can simultaneously approve a change in branded-drug labeling, the Agency “ensures that the approved labeling for a generic drug continues to be the same as the approved labeling of its RLD.” (emphasis supplied).  See Proposed Rule at 34.  FDA is also careful to point out that the statute requires a generic drug label to be identical to the branded drug “at the time of approval,” and that only FDA regulations have taken the position that generic drug labeling must maintain the same label as the branded drug throughout the lifecycle of the generic product.  Proposed Rule at 13.  A position the Agency now proposes to alter.

Assuming FDA has authority to issue the Proposed Rule, it will give patients an avenue for recovery from generic drug companies after suffering an injury.  But will it keep patients from harm in the first place?  The desirability of FDA’s Proposed Rule from a patient-safety perspective is certainly open to debate, and will be a point of serious contention in the coming months.  This is evidenced both by the Agency’s own admittedly changed position, and by the immediate and opposite reactions to the Proposed Rule.  See, e.g., Statement of the Generic Pharmaceutical Ass’n; Press Release: Harkin Welcomes Release of Proposed Rules to Protect Consumers Using Generic Drugs.  

FDA acknowledges its previously long-held view that the labeling of generic drugs must be identical to that of the listed drug in order to ensure patient safety, not least because a generic drug’s approval relies upon safety and efficacy studies of the listed drug.  See 57 Fed. Reg. 17,950, 17,961 (Apr. 28, 1992).  It also “acknowledges that there may be concerns about temporary differences in safety-related labeling for drugs that FDA has determined to be therapeutically equivalent.”  Proposed Rule at 18.  Nevertheless,  the Agency argues that the changing prescription drug landscape, in which 80% of the drugs dispensed are generic, has altered the risk-benefit balance between clarity and consistency on the one hand, and speedier access to safety information on the other.  Proposed Rule at 14.  FDA proposes to address the inevitable confusion regarding multiple versions of safety labeling through increased transparency – a website listing all of the pending CBE-0 supplements for safety-related labeling changes.  Proposed Rule at 19-20.  We anticipate that, particularly in the case of drug products for which there are multiple generic manufacturers, this website would be a virtual cacophony of labeling.

The comment period on FDA’s Proposed Rule will be open at least 60-days after its publication in the Federal Register – until January 12, 2014 – and likely longer.  The Docket No. is FDA-2013-N-0500.