Addressing Potential Drug Risks: The Limits of Testing, Risk Signals, Preemption and the Drug Reform Legislation

44 Pages Posted: 22 Nov 2007 Last revised: 2 Jun 2013


The cardiovascular risks for Vioxx found in tests after it was on the market were known for some time before a warning was added to the label following extensive negotiations between the agency and the drug sponsor. That delay led to calls for drug reform. This paper examines why pre-market testing is limited in its ability to detect risks as described in a report of the Institute of Medicine. The article also surveys the important expansions in regulatory authority recently signed into law. The new law will give the Food and Drug Administration (FDA) the resources to establish an active surveillance system to detect adverse drug effects. The agency has also been given express authority to require postmarket tests and labeling changes and has stronger enforcement powers. Before the new authority can be implemented, though, the agency will have to adopt rules on the governing procedures, a process which could take some time. While the new law aims to address the safety issues raised by Vioxx, it basically is a compromise that needed to be signed to renew the user fees that fund a major part of FDA's drug regulatory program.

Another focus of this paper is to raise matters that need to be addressed by the agency as it implements its new authority, including the adequacy of the present scope of clinical drug testing and the impact of the new surveillance system. The paper also stresses the need for disclosures to physicians about the limits that remain, and about notable risk signals that are found postmarket. The agency has an important role as an authoritative gatekeeper in determining when an emerging risk warrants being included in the labeling. This paper suggests supplementing that approach with an access model that alerts physicians to important risk signals that are under agency review. These signals include undertakings by the sponsor for additional follow-up studies on emerging risks and the factual findings about serious risk made in medical reviews of clinical studies for drugs on the market. Putting these signals in the labeling or on an agency website can permit physicians to make a more informed judgment in advising patients about the balance of risks and benefits that a drug has. The paper also examines the IOM recommendations that there be a moratorium on consumer advertisements for newly-approved drugs because the risks are not fully known. Congress has not required a moratorium, nor a disclosure about the potential for additional risks, and has instead provided for a report on the use of a symbol in the advertisements.

The extent to which drug risks need to be disclosed is also of key importance for product liability suits. FDA issued a policy statement in 2006, based on an authoritative expert model, which would preempt liability suits if the substance of the risk had been proposed in some way to the agency and no change in the labeling had been made. Litigation is pending on the agency's policy and the Supreme Court has granted certiorari on some FDA preemption cases involving drugs and devices. The aim here is to examine the agency's Preemption Statement on a policy basis. Among the difficulties is that agency inaction leads to preemption without providing for accountability and that the policy does not reinforce the responsibility of the manufacturer to reduce risk. While reconsideration of the agency's statement is needed, leaving the need for warnings about emerging risks to be resolved in liability suits is also not an ideal way to address an important and difficult issue. The agency should recognize that a drug sponsor can petition the agency when the sponsor is uncertain if new risk information requires an immediate change in the labeling. After a limited time for agency review, an agency website should indicate that the matter is under review. That designation and the agency's response is a better candidate for having a preemptive effect on tort liability than the agency's present policy.

Keywords: drugs, drug risks, limits of testing,notable risk signals, preemption, drug reform, drug legislation, drug reform legislation, Vioxx, cardiovascular risks, pre-market testing, FDA regulatory authority, Food and Drug, active drug surveillance, user fees

Suggested Citation

Gilhooley, Margaret, Addressing Potential Drug Risks: The Limits of Testing, Risk Signals, Preemption and the Drug Reform Legislation. South Carolina Law Review, Vol. 59, p. 347, 2008, Seton Hall Public Law Research Paper No. 2007-010, Available at SSRN:

Margaret Gilhooley (Contact Author)

Seton Hall Law School ( email )

One Newark Center
Newark, NJ 07102-5210
United States

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