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

Therapeutic Innovation & Regulatory Science
Mark SlomianyMahmud Hassan

Abstract

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 ...Continue Reading

References

May 1, 2002·JAMA : the Journal of the American Medical Association·Karen E LasserDavid H Bor
Dec 2, 2004·JAMA : the Journal of the American Medical Association·Phil B FontanarosaCatherine D DeAngelis
May 9, 2007·Health Affairs·Michael B Enzi, Edward M Kennedy
May 6, 2009·Health Affairs·Susan H Busch, Colleen L Barry
Oct 9, 2013·Medical Dosimetry : Official Journal of the American Association of Medical Dosimetrists·Jennifer L PetersonStephen J Ko

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Citations

Oct 2, 2020·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Reynold D C FranciscaSabine M J M Straus
Aug 16, 2018·Expert Opinion on Drug Safety·Reynold D C FranciscaSabine M J M Straus

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Software Mentioned

Symbicort
REMS

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