Drug Safety and the Cost of Monitoring: The Role of REMS in Risk Management.

BACKGROUND: The mission of the US Food and Drug Administration (FDA) can be viewed as a pendulum that swings between protecting public health and patient safety and promoting the public health through the drug review and approval process. Two decades of legislation have by and large provided the FDA with additional resources under the successive reauthorizations of the Prescription Drug User Fee Acts (PDUFA) to provide a necessary infusion of funds to hire medical experts, scientists, and epidemiologists, among other disciplines, to expedite review of new drug and biologic applications. However, a renewed attention to potential adverse drug experiences, culminating in the Vioxx withdrawal, has resulted in the passage of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Under this act, the FDA was authorized to impose postapproval requirements on the biopharmaceutical industry through the imposition of risk evaluation and mitigation strategies (REMS) and postmarketing trial (PMT) requirements to improve drug safety. Despite the extensive dialogue between stakeholders and lawmakers in the development of the FDAAA, there remains some uncertainty as to the exact impact of REMS on not only operational costs for both industry and health care professionals but also product sales and prescribing habits in the 5 years since its implementation. METHODS: Recognizing that in the past 2 years, the use of REMS has shifted markedly, we sought to provide greater clarity on the duration of REMS requirements and impact of REMS on drug sales. RESULTS: While in absolute terms, the use of REMS may be declining, the REMS experience has provided an important, perhaps even critical, step in the development of current risk management strategies aimed at improving patient safety.

Organizational boundaries of medical practice: the case of physician ownership of ancillary services.

Physician ownership of in-office ancillary services (IOASs) has come under increasing scrutiny. Advocates of argue that IOASs allow physicians to supervise the quality and coordination of care. Critics have argued that IOASs create financial incentives for physicians to increase ancillary service volume. In this paper we develop a conceptual framework to evaluate the tradeoffs associated with physician ownership of IOASs. There is some evidence supporting the existence of scope and transaction economies in IOASs. Improvement in flow and continuity of care are likely to generate scope economies and improvements in quality monitoring and reductions in consumer transaction costs are likely to generate transaction economies. Other factors include the capture of upstream and downstream profits, but these incentives are likely to be small compared to scope and transaction economies. Policy debates on the merits of IOASs should include an explicit assessment of these tradeoffs.This research was supported in part by funding from the American Association of Orthopaedic Surgeons (AAOS).

Pregnancy at or beyond age 40 years is associated with an increased risk of fetal death and other adverse outcomes.

OBJECTIVE: The objective of the study was to determine the frequency of fetal death in women 40 years of age or older (AMA). STUDY DESIGN: Retrospective study of all singleton pregnancies delivered at our institution between the years 1989 and 2004 was performed. The primary outcome measure was the risk of fetal death at various gestational ages. We also investigated the frequency of maternal comorbidities, preterm delivery (PTD), and low and very low birth weights (LBW, VLBW). RESULTS: Data were available for 126,402 singleton deliveries. AMA was an independent risk factor for fetal death at 28-31 weeks (adjusted odds ratio [AOR] 2.93, 95% confidence interval [CI] 1.76-4.92), 32-36 (AOR 1.73, 95% CI 1.05-2.83), 37-39 weeks (AOR 1.63, 95% CI 0.97-2.75), and 40-41 weeks (AOR 2.28, 95% CI 1.18-4.4). AMA was associated with increased rates of PTD, LBW, and VLBW. CONCLUSION: AMA is associated with an increased rate of fetal death and other adverse obstetrical outcomes. Antepartum fetal surveillance may be warranted in these women.

Synthesis and biological properties of novel glucocorticoid androstene C-17 furoate esters.

A series of novel corticosteroid derivatives featuring C-17 furoate ester functionality have been synthesised. Profiling in vitro and in vivo has resulted in the identification of a compound with a longer duration of action and a lower oral side effect profile in rodents compared to budesonide.