Former FDA Commissioner Chimes in on Preemption DebateMarch 2, 2008
Preemption of state law concerning FDA-regulated products (drugs, devices, and foods) has been the hot topic over the past few weeks. First, on February 20, 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that preemption principles and the 1976 Medical Device Amendments bar common law claims on the basis of safety or effectiveness of devices approved by FDA under a Premarket Approval Application (see 2/22/08 FDA Law Blog post). Then, on February 25, 2008, the U.S. Supreme Court heard oral arguments in Warner-Lambert v. Kent, which concerns Warner-Lambert’s REZULIN (troglitazone), certain people alleging injuries caused by the drug product, and a Michigan law immunizing pharmaceutical companies from products liability claims except in cases of “fraud-on-the-FDA.” Also, as we recently reported, the Supreme Court of California ruled in February 2008 in a case concerning farm-raised salmon that preventing a company from bringing a private action for violating a California law when the FDC Act authorizes such a state law would constitute an intrusion into state sovereignty.
Now, as reported by our fellow blogger Ed Silverman over at Pharmalot, former FDA Commissioner Dr. David Kessler and Georgetown University Law Professor (and former Public Citizen attorney) David Vladeck published an essay in the Georgetown Law Journal highlighting two of what they call the “most problematic aspects of the FDA’s pro-preemption policy – one legal, the other practical – that do not stand out in more comprehensive treatments of the issue.” The authors summarize their concerns as follows:
The first point we make is that the FDA’s pro-preemption arguments are based on a reading of the FDCA that, in our view, understates the ability of drug manufacturers to change labeling unilaterally to respond to newly discovered risks, or to seek labeling changes from the FDA. In fact, drug manufacturers have significant authority – and indeed, a responsibility – to modify labeling when hazards emerge and may do so without securing the FDA’s prior approval.
Our second concern is that the FDA’s pro-preemption arguments are based on what we see as an unrealistic assessment of the agency’s practical ability – once it has approved the marketing of a drug – to detect unforeseen adverse effects of the drug and to take prompt and effective remedial action.
The authors take exception to FDA’s current pro-preemption policy. They have a different perspective than FDA about the relevant Agency decision that should be subject to review in failure-to-warn cases arising under state law:
The FDA focuses on the approval process, suggesting that the FDA’s approval of a drug’s labeling reflects the agency’s definitive judgment regarding risks that must be shielded from the possible second-guessing that might take place in a failure-to-warn case. . . . But in our view, the FDA is wrong to focus on the moment of approval as determinative of the preemption question. The relevant timeframe is postapproval, and the question, in our opinion, is what did the FDA and the drug company know about a drug’s risks at the time the patient-plaintiff sustained the injury.
The authors also argue that a “Rule of Construction” included in the recently-enacted FDA Amendments Act (“FDAAA”) undercuts FDA’s pro-preemption position. In this provision, which was added to FDC Act § 505(o) by FDAAA § 901(a), Congress amended the law to state that the Agency’s labeling authority over drugs and biologics “shall not be construed to affect the responsibility of the [manufacturer] to maintain its label in accordance with existing requirements, including [21 C.F.R. § 314.70 and § 601.12] (or any successor regulations).” This provision was reportedly included in FDAAA instead of an express preemption provision. According to the essay’s authors, “[t]he codification of this obligation undercuts the key pro-preemption argument the FDA and manufacturers make – namely, that the FDA alone decides the content of drug labels.” In January 2008, we reported on FDA’s proposal to codify its “longstanding position” on postapproval labeling changes that could significantly affect preemption defenses. Two of the regulations cited in the proposal are 21 C.F.R. § 314.70 and § 601.12.