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Even before the intense scrutiny that started in September when Vioxxs manufacturer removed the drug from the market due to safety concerns, the U.S. Food and Drug Administration and the pharmaceutical industry faced a bumpy road.
One of the biggest challenges has been the pipeline problem, the slowdown instead of the expected acceleration in innovative medical therapies reaching patients. In its March 2004 Critical Path report, FDA explained that better tools are needed earlier in the drug development process to identify successful products and to eliminate products that will later fail.
The pipeline problem, along with heightened attention to drug safety issues and FDAs initiatives for bar codes and radio-frequency identification technology on pharmaceuticals, present multi-faceted opportunities for IT companies and researchers particularly for those with experience in health care or drug development. Each could be the subject of its own article. The items below highlight key areas of opportunity for IT innovators.Tools for Drug Development
The costs of bringing a new chemical entity from laboratory concept to commercial medical product has been estimated by some to be as high as $800 million to $1.7 billion. Inefficiencies in drug development contribute to rising costs. Preclinical tools for assessing product safety and demonstrating that a product will actually benefit people have not kept pace with advances in laboratory biomedical discoveries.
IT tools are a critical part of the better toolkit necessary to make drug development more predictable and efficient. New computer-based predictive models, for example, are urgently needed. Some have argued that extensive use of computer modeling technologies could reduce the overall cost of drug development by as much as 50 percent. FDA, for example, is working with outside partners to develop quantitative clinical trial modeling simulation software to improve clinical trial design and predict outcomes.
Better imaging technologies, such as for measuring drug absorption and distribution, may provide powerful insights into the biological effects of pharmaceuticals. But such tools need to be specifically developed and evaluated for drug development. These are but two examples.Assessing Drug Safety
New drugs are typically studied in about 3,000 patients before approval. As a result, serious adverse events that occur in one-in-10,000 patients substantial if the drug is used by millions of patients will not be identified until after a drug is widely used. FDAs adverse event reporting system is dependent on voluntary reports from health care providers.
Better computer systems are needed both for collecting data and analyzing patterns associated with the use of pharmaceutical products. In August, UnitedHealth, an insurer of more than 20 million, plans to implement its own computer monitoring system to track the four new drugs most frequently prescribed for its patients. And Medicare is considering using its database to track the safety and effectiveness of medications used by its beneficiaries. But these efforts, while promising, are in their infancy and leave out vast numbers of patients and drug products.Integrating Drug Bar Codes into Health Care
In February 2004, FDA finalized regulations requiring bar codes on most prescription drugs and certain over-the-counter drugs. This bar code rule is designed to support and encourage widespread adoption of advanced IT systems that, in some hospitals, have reduced medication error rates by as much as 85 percent. Newly approved drugs must comply within 60 days of approval. Already marketed drugs and all blood products must comply by April 2006.
FDA expects that the use of standardized bar codes will result in hospitals, pharmacies and other health care facilities accepting and investing in bar code technology at a faster rate. Demand for multi-faceted IT systems that improve both productivity and patient safety and well-being will only increase. Facilities already using bar coding will look for enhancements to these systems, and those considering whether and how to adopt bar coding will be evaluating their overall IT needs and options.Radio-Frequency Identification (RFID) Technology
FDA views RFID as critical to ensuring the long-term safety and integrity of the U.S. drug supply because of its ability to track, trace, and authenticate drug packages throughout the chain of distribution. RFID is not required at this time, but FDA expects to see widespread pharmaceutical industry adoption of the technology by 2007.
Last November, FDA issued guidance for implementing RFID feasibility studies and pilot programs for drug products. The initiative is intended encourage further activity in the area, including more applied RFID research in areas such as tag numbering, optimal frequency use, data management and effects of RFID on drug products, particularly biologicals. FDA also hopes that more companies will use RFID to gain experience with transferring, storing, securing and utilizing data RFID provides.
Wisconsins IT innovators are well-positioned to help FDA and the pharmaceutical industry meet the challenges of the bumpy road ahead and, at the same time, help strengthen the nations drug supply.
Patricia Kaeding, an attorney, was an associate chief counsel at the U.S. Food & Drug Administration from 1993-2003. This article opens a new monthly WTN column on FDA issues. Next months column will discuss FDA inspections of laboratories and clinical research facilities.