Information on the Rule of Construction Regarding Federal Preemption
Congress can and should expect substantial improvement in drug safety as a result of passing new law. But recent events remind us that the FDA often does not recognize drug harms until after many unknowing patients have been harmed and even when they do, the FDA must overcome substantial obstacles to insist on hazard warnings beyond what manufacturers chose to disclose. The FDA cannot catch every instance of manufacturer misconduct or provide maximum protection against adverse drug events. The FDA and state remedies are complementary; both are needed safeguards to protect American families.
The language in the discussion draft is designed to ensure that Congress does not inadvertently preempt common law remedies when it grants the FDA new authority to regulate drugs and devices in order to improve patient safety. The language says:
“Nothing in this Act or the amendments made by this Act may be construed as having any legal effect on any cause of action for damages under the law of any State (including statutes, regulations, and common law).”
Rule of Construction:
- What does the rule of construction accomplish? The language is essentially a savings clause that preserves state causes of action for damages from being barred simply by the mere fact of a comprehensive regulatory scheme. Preemption created by a comprehensive regulatory scheme is referred to as “field” preemption.
- What could happen if this language is not included? If PDUFA were construed to preempt state liability rules, once the FDA receives new safety data, manufacturers are shielded from liability for failing to tell the public about drug hazards, even if the FDA fails to analyze or review the data or takes no action to modify a drug label. Such a result would reverse the long established standard that the FDA’s approved label is the minimum requirement necessary to warn patients of drug risks.
- How does the rule of construction enhance safety? In most instances, drug companies have the right, under existing law voluntarily to modify drug labels to inform the public of potential risks. The common law duty to warn creates incentives to encourage drug companies to do so. When drug companies promptly disclose potential drug hazards as they become aware of risks, they face little threat of liability for failing to do so. The rule of construction would preserve this duty to warn regardless of any new data that is required to be disclosed to the FDA or any requirements for post-market testing or testing on particular patient populations.
- How would the rule of construction affect the House bill? The language would make clear that the House does not intend to preempt state remedies, even if it places additional requirements on the FDA or the pharmaceutical industry.
- How would the rule of construction affect the Senate passed bill? The discussion draft would make it clear that any new proposed safety requirements do not preempt state law requirements. Title II of the recently passed Senate version of the PDUFA reauthorization, S. 1082, grants the FDA new authority to conduct post approval safety surveillance activity in order to improve drug safety. Increased surveillance of drug effects will improve patient safety and will lead to a positive public health development. However, if the Senate version of the drug safety title is enacted, it likely will provide greater credibility to the arguments of drug manufacturers and the Bush Administration that the new law creates a “pervasive regulatory scheme” that preempts the field of drug labeling and shields drug manufacturers from the general duty to warn customers of the hazards posed by their products. Currently, courts are skeptical of such claims.
Preemption Basics:
- What is preemption? There are three types of preemption: express preemption; field preemption; and conflict preemption. Express preemption occurs where Congress has expressly stated that the federal law supersedes state law. Field preemption may be inferred from the existence of a pervasive regulatory scheme. Conflict preemption occurs where there is an actual conflict between the state and federal laws such that it is impossible to comply with both laws, or the state law stands as an obstacle to the accomplishment of the full purpose and objectives of Congress.
- How does conflict preemption differ from field preemption? A finding of conflict preemption requires the existence of a state law that covers the same subject matter. Field preemption does not require the existence of a state law which would make it impossible to comply with both state and federal law. Field preemption only requires a comprehensive federal regulatory scheme or other dominant federal interest that might justify an inference that Congress intended to displace state law. The drug safety provisions in the PDUFA reauthorization create field preemption.
- How does the drug safety bill (S. 1082) change the current labeling system to result in a court likely dismissing injured patients’ failure-to-warn claims under field preemption? Under the current labeling system, FDA regulations mandate the general format and content of all prescription drug labels. Final approval of a drug application is conditioned upon the applicant incorporating the specified labeling changes as directed. However, a manufacturer may voluntarily or unilaterally strengthen the warnings without prior FDA approval and without concern that the product will be deemed misbranded. Therefore, the FDA’s approved label is the minimum labeling requirement. However, under S. 1082, a drug manufacturer’s ability to voluntarily or unilaterally make changes to the warning label is eliminated. If the manufacturer takes such action, the FDA may deem the drug misbranded. Accordingly, the FDA standards no longer are the minimum standards – they become the pervasive regulatory scheme which preempts state law.
Warning Label Rule
- How can the rule of construction be improved? The rule of construction could be improved by adding language to address the problem of conflict preemption created by the FDA’s prescription drug warning label rule. It would merely require the insertion of a second sentence as follows: “An action for damages or liability under state law shall not conflict or render impossible compliance with a specific substantive requirement for a drug established under this Act or its implementing regulations.”
- Why is it necessary to address conflict preemption? In January, 2006, the Food and Drug Administration issued a final drug warning label rule, which noted in the preamble that the rule preempted all state law requirements pertaining to a drug company’s obligation to warn the public of a drug’s potential side-effects without regard to whether the drug company intentionally withheld information or negligently failed to continually monitor, test, and analyze data regarding the safety, efficacy, and prescribing practices of the drugs.
- How did the FDA exceed Congressional authority? The FDA concedes that Congress never expressly authorized them to preempt state law in this manner; yet the agency has ignored Congressional intent and preempted state remedies at the expense of consumer safeguards. This final rule, which completely reversed the agency’s long standing position against preemption in its Notice of Proposed Rulemaking, came on the heels of the agency filing several amicus briefs in favor of the drug manufacturers to the detriment of patients injured by defective drugs, even though the FDA was not under any obligation to become involved in these cases.
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