In a lengthy essay in The Georgetown Law Journal, David Kessler, the former commish, and David Vladeck, a Georgetown University Law Center professor, are very clear about preemption - they don't like it. The issue, of course, is whether FDA approval of a drug preempts state law claims challenging safety, efficacy, or labeling. The concept is being reviewed by the US Supreme Court, because preemption would preclude patients from suing a drugmaker through state law. This is a brief excerpt...
"This essay highlights what we believe are two of the most problematic aspects of the FDA's pro-preemption position - one legal, the other practical - that do not stand out in more comprehensive treatments of the issue. The first point we make is that the FDA's pro-preemption arguments are based on a reading of the (Food, Drug & Cosmetic Act) 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. After all, there are 11,000 FDA-regulated drugs on the market...with nearly 100 more approved each year. The reality is the FDA does not have the resources to perform the Herculean task of monitoring comprehensively the performance of every drug on the market...Given the FDA's inability to police drug safety effectively on its own, we question the wisdom of the FDA's efforts to restrict or eliminate the complementary discipline placed on the market by failure-to-warn litigation.
"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 post-approval, 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. After all, the FDA's knowledge-base of the risks posed by a new drug is far from static. At the time of approval, the FDA's knowledge-base may be close to perfect, but it is also highly limited because, at that point, the drug has been tested on a relatively small population of patients.
"Once the drug enters the marketplace, risks that are relatively rare, that manifest themselves only after an extended period of time, or that affect vulnerable subpopulations, begin to emerge. These are often not risks foreseen by the drug's manufacturer or the FDA and, for that reason, are not addressed on the label. And at the time the FDA adopted its pro-preemption position, the agency did not have the authority to compel labeling changes, but instead had to negotiate changes with the drug's sponsor. The FDA's statutory and regulatory tools for gathering post-approval information are relatively crude and often ineffective, especially when contrasted with its tools for information gathering prior to approval. For that reason, the tort system has historically provided important information about these newly emerging risks to physicians, patients, and the FDA.
"The FDA's shift of position also comes at a particularly inopportune time for the agency. Although the FDA now argues for broad preemption of failure-to-warn claims, the agency's assertion that it is able single-handedly to ensure drug safety has been undermined by a number of highly publicized regulatory failures."