Defining the Challenges Surrounding Innovation and Safety (Part One)

author: Frank L. Douglas, Austen BioInnovation Institute
author: Una Ryan, Waltham Technologies, Inc.
author: Robert J. Spiegel, Schering-Plough Research Institute
author: Robert Tepper, National Advisory Council for Human Genome Research (NACHGR)
author: John A. Fallon, Massachusetts Association of Health Plans
author: Ernst R. Berndt, Sloan School of Management, Massachusetts Institute of Technology, MIT
published: June 4, 2013,   recorded: August 2005,   views: 61
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Description

Recent scrutiny of the pharmaceutical industry -- brought into sharp focus by Merck’s Vioxx trial -- is leading to some big changes in the development and marketing of drugs. This panel shares deep concerns about the direction of public opinion and policy. Una Ryan’s company has cooked up cost-effective vaccines that may help prevent and treat common diseases, and which can be administered orally, with a single dose, delivering quick protection. Now, new rules may demand more elaborate testing before her drugs come to market, says Ryan, with potential clinical trials running up to half a billion dollars. She says, “If we’re going to have to go through ridiculous and onerous regulatory cycles, we won’t be able to sell at low prices.”

Robert Spiegel wonders if the new regulatory environment will continue to allow drug makers to “take chances early, and make investments taking large risks?” If the movement is “toward zero tolerance toward drug safety, and there’s a frenzy to get rid of drugs with some safety issue,” then the whole economic model of the industry is in peril, he says.

Robert Tepper outlines the new, “post-Vioxx” pattern, “where regulators say the job of the company is to begin risk management from the lab. As soon as we see some side effect, we must build that into our development program so we understand how it plays out.” This means drawing up long-term plans involving follow-up studies and registries of every patient starting the drug. “My plea, says Tepper, is “to keep this flexible…based on science and feasibility.”

John Fallon worries that health plans like his will be playing catch-up to build electronic medical databases and physician-supported tools to help monitor drug reactions in large populations. Employer groups, already unhappy with the costs of health care, are now “saying to health plans…where were you when Vioxx got into trouble?”

Ernst Berndt notes that with new FDA standards involving drug surveillance, “IT and engineering are becoming an important part of the drug evaluation and monitoring process,” which will mean not only that databases must be standardized nationally, but internationally as well.

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