Professor Catherine M. Sharkey ·
83 Geo. Wash. L. Rev. 1609 ·
In the United States, food and drug safety is regulated in two ways: a
stringent ex ante, national regime led by the Food and Drug Administration
(“FDA”) and a robust ex post system of state-law enforcement. This federalist
structure of dual regulatory levels sets the stage for synergy and for conflict.
Two recent preemption lawsuits showcase a novel dimension of the dual
structure: states competing with or complimenting the FDA as regulators of
food and drug safety. In Zogenix, Inc. v. Patrick, a federal district court enjoined
Massachusetts from enacting a statewide ban on Zohydro, an FDA approved
opioid analgesic drug, but upheld the state’s subsequent prescription
and dispensation-related restrictions. In Grocery Manufacturers Ass’n v. Sorrell,
food industry representatives challenged a Vermont law mandating labeling
of genetically engineered food—labeling the FDA had not required.
Both cases explore how states can regulate drug and food safety without
treading impermissibly upon the FDA’s turf. In doing so, they raise the issue
of who should determine if state regulatory efforts advance or impede the federal
regulatory scheme. Are courts or the regulating agencies the better arbiters?
If the latter, when do their conclusions warrant judicial deference?
This Article advances two claims. First, courts, when facing implied obstacle
preemption challenges to state regulations, should consider the FDA’s
view on the matter—namely whether the agency considers the state-level regulation
to conflict with its national regulatory agenda. In Zogenix, the court,
strikingly, paid no attention to the FDA Commissioner’s support of Massachusetts’s
proposed restrictions on the prescribing and dispensing of Zohydro.
In Sorrell, the court had before it informal policy guidance from the FDA that
suggested that the agency was somewhat open to state labeling mandates. Deference
to the FDA’s position in each case would have readily resolved the
preemption challenge.
Second, these cases reiterate and reinforce the key argument of the Administrative
Conference of the United States (“ACUS”) 2010 Recommendation,
Agency Procedures for Considering Preemption of State Law: if there
will ever be a coherent body of case law and regulatory policy in the realm of
food and drug laws, courts must probe the extent to which the FDA considered
relevant state interests in the regulation enactment process. Rather than
blindly deferring to the federal agency’s view, courts should evaluate whether
that view resulted from a responsible process affording states the chance to
articulate how their own proposed state regulation fits with the federal regulatory
scheme.
