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Abstract:
When Vioxx was removed from the market because of risks found after approval, issues arose about the adequacy of FDA's authority and procedures to require warnings and testing for approved drugs. This paper examinies the regulatory and legislative history about the debate and the changes adopted by Congress in 2007 to strenthen FDA's authority. The agency has now been given authority to impose civil money penalties when needed changes are not made, but before this authority can be used the agency has to establish dispute resolution procedures about the changes needed. The article, published in 37 Seton Hall L. Rev. 941 (2007) considers the factors that bear on the type of dispute procedures that should be considered. The article also examines the value of encouraging better initial testing and comparative efficacy testing for drugs and the means to encourage that testing.

drug legislaton, drug safety, Vioxx, FDA, Food and Drug Administration, drug testing

Abstract:
Drugs are generally tested for efficacy against a placebo, rather than comparatively to determine if they have a significant therapeutic benefit with respect to existing drugs. Consumer advertisements for prescription drugs emphasize the benefit of the specific drug, even though the choice to be made by the physician is a relative one that takes account of lifestyle changes and other therapies and their risks and benefits.

This paper considers the need for better information in the consumer advertisements to put the relative choice into perspective. The advertisements should indicate the need for advice from the doctor about the range of treatments available. When a drug by the same maker succeeds a similar drug going off-patent, the advertisement should make clear the limited ways in which the new product is an advance. More broadly, the drug ads should disclose when drugs have not been comparatively tested to determine if they have a therapeutic advantage. Finally, the television ads should state orally the name of the generic version of the drug to make the name more familiar. These measures can help to alleviate consumer confusion about the benefits of a particular drug and reduce the potential that consumers will pressure doctors for a specific drug when alternatives or less costly ones may be suitable.

Abstract:
The extent to which FDA decisions preempt tort liability for prescription drugs has become an important and contentious issue. The agency has issued a Preemption Policy that favors preemption when a drug manufacturer consults with the agency about a risk. The Supreme Court has considered two preemption cases this term and is expected to make an important ruling on drug preemption next term in Wyeth v. Levine. Wyeth has some unusual factors, though, since the label had a warning about the risks from the method of administration, and the plaintiff's expert testified that the label should not have allowed the method at all.

The most important and difficult preemption question is the liability for risks that are found from use after the drug is on the market. This paper will examine the factors that could limit the scope of the Wyeth decision. Instead of having a broad rule that there never is preemption or there always is preemption, a better approach is to focus preemption on matters that the agency has specifically addressed based on current and accurate information. The consultation process between the agency and the drug company also needs to be made more transparent about the information available about emerging risks.

drug preemption, drug safety, torts, products liability, Wyeth v. Levine

Abstract:
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.

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

Abstract:
This article considers lessons from the history of the agency's adaptation of the regulatory statute to new developments. Some of these developments have been led by the agency and some by the courts. Notable measures include the recognition of a de minimis risk level for carcinogens in many products, the regulatory acceptance of accelerated approval for drugs to treat life-threatening conditions, and the policy of regulating genetically-modified foods within the existing regulatory framework. On the other hand the Supreme Court rejected the FDA's effort to extend its regulatory jurisdiction to cover tobacco. In recent years, the constitutional protection for commercial speech protections have made it necessary for the agency to adapt its traditional policies to the approach of permitting disclosures as an alternative to mandatory regulation. Agencies, including FDA, that find themselves involved in implementing the prescription drug benefits to seniors need to consider their role in adapting the law to meet the new challenge.

Administrative law, rulemaking, statutory interpretation, Delaney Clause, FDA, Food and Drug Administration

Abstract:
The lower courts have recognized that the constitutional protections for commercial speech permit food supplements to make health claims with disclaimers even though the claim does not comply with regulatory requirements for agency approval and scientific support. An example of a health claim is a claim that vitamins may reduce the risk of cancer. The court found that the marketer has to permit agency review of the disclaimers in advance, and that the agency could preclude a claim if the agency could show consumers would be deceived even with disclaimers.

On remand, FDA issued guidance on the type of disclaimer suitable for claims in light of the scientific support for the claim. The guidance makes it possible to consider in a concrete setting the adequacy of disclaimers to prevent consumer confusion on scientific matters that affect health. The guidance ranks the support by grades such as B, C or D and indicates a suitable disclaimer. Unfortunately, the FDA guidance did not provide for the use of the letter grade in the disclaimer on the label for the product, the type of information most likely to help consumers in understanding the strength or weakness of the claim. Lastly, the article examines a court decision finding that commercial speech did not permit a disease treatment claim with disclaimers for the non-food supplement saw palmetto. The court found disease treatment claims to be illegal without FDA approval, under the first step of the Central Hudson test, making the use of disclaimers to prevent deception irrelevant. While safety factors may also explain the result, it is notable that the courts have found a way to draw lines that allow Congress to establish mandatory testing and approval requirements for some drug claims.

Commercial speech, commercial free speech, FDA and the constitution, health claims on foods, health claims on supplements

Abstract:
Under FDA's labeling policy, no labeling is needed about the use of the process of genetic engineering in foods. Disclosures are only needed if the modification changes the material characteristics of the food in a way that requires a new name, or if the change involves risks to consumers such as the transfer of an allergen. This article considers the need for disclosure when the transfer involves a gene from a different species beyond the reach of traditional plant breeding. For example, if a sugar gene were transferred to a fruit or vegetable to enhance flavor, the name should reflect that the food is sweetened, but a disclosure also seems needed in the ingredient statement to reflect the new plant source of the characteristic.

Many gene transfers are made not for taste and nutrition but for agronomic purposes. Bacteria genes derived from genes used in pesticide sprays are widely incorporated in corn and other foods. A field test was even made about the ability to transfer a fish gene to a fruit to retard frost damage. Labeling agronomic uses presents special hurdles. FDA's authority over chemical pesticides is statutorily limited, and labeling only bioengineered pest-protectants could advantage chemical pesticides. The article suggests consideration of a labeling requirement that all foods using chemical or bioengineered pest protectors be labeled as having "crop protectors," leaving it to consumers to seek out more information through voluntary labeling. A transfer that involves use of an animal or fish gene as a crop protector should be specifically identified.

Lastly, bioengineered uses can present species environmental risks, as exemplified by the proposal for FDA approval of gene-modified salmon that would produce larger fish in fish-farms. However, some of these fish are likely to escape and there is scientific uncertainty whether the interbreeding or competition with the escaped fish could alter the natural species. One response to the uncertainty would be to have labeling that informs consumers that protective measures are in place to minimize and monitor the risk. That labeling might encourage the development of better techniques to prevent escape.

Biotechnology, genetically modified foods, food biotechnology, bioengineered salmon

Abstract:
The extent to which FDA decisions can preempt tort liability for prescription drugs is a critical issue that the Supreme Court will address this term in Wyeth v. Levine. The agency has issued a Preemption Policy that favors preemption when a drug manufacturer consults with the agency about a risk. Wyeth has unusual factors since the label warned of the risk from the method that led to the injury, and the plaintiff's expert testified that the label should not have allowed the method at all.

The most important and difficult preemption question is the liability for new risks that are found from use after the drug is on the market. This paper will examine the factors that can limit the scope of the Wyeth decision. Instead of having a broad rule recognizing preemption generally, the determination should focus on matters that the agency has specifically addressed based on current and accurate information. Moreover, the consultations between the drug company and the agency about the need for warnings for emerging risks need to be based on means that ensure "fairness and deliberation."