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By Donna Young
Washington Editor
WASHINGTON - As the FDA sets out to implement its congressional mandate to develop a national active surveillance network for monitoring medical products, the agency must first and foremost ensure that the privacy of patients is not breached, health policy experts said.
While the use of electronic health information can accelerate the timeliness, accuracy and effectiveness of drug safety monitoring, it also poses concerns about patient privacy, said Kristen Rosati, a partner with the Phoenix law firm Coppersmith Gordon Schermer & Brockelman plc.
The legal risk is not high for health information exchange programs using electronic health data for monitoring drug use as long as the program rigorously protects the privacy and security of individually identifiable information, she told attendees at a Washington forum where health policy experts and analysts gathered to examine the challenges the FDA is facing in developing its Sentinel network - a national, integrated electronic system for monitoring medical product safety, which was mandated by Congress under the FDA Amendments Act (FDAAA) of 2007. (See BioWorld Today, May 23, 2008.)
The FDA's system, noted Richard Platt, an epidemiologist and professor of medicine at Harvard Medical School, will not be one large database. Rather, he explained, it will be a so-called distributed data network in which the health information remains with the participating organizations but is accessible for research queries.
The network will consist of multiple, existing data sources, such as electronic health record systems and medical claims databases maintained by private or government entities, he added.
FDAAA calls for the public-private network to have accessible data for drug monitoring from 25 million American patients by 2010 and 100 million by 2012, said Mark McClellan, director of the Engelberg Center for Health Care Reform at the Washington think tank the Brookings Institution, which hosted the forum.
With the new funding and authorities granted under FDAAA, said McClellan, who served both as the head of the FDA and the Centers for Medicare & Medicaid Services during the Bush administration, "there is considerable momentum for working together to establish a fundamentally better system for post-market evidence on drugs and other medical products."
"With the new law and new opportunities, we may be entering a new era in terms of how drugs are evaluated and how they are used once they are on the market," he said.
The Sentinel network is "far more than just being able to create a more elegant system for adverse-event detection and reporting," said FDA Commissioner Andrew von Eschenbach. "This is about transforming health care," he declared.
The agency is not pursuing the Sentinel system now "only because Congress told us to do it," but because the information technologies and infrastructure are available to gather and analyze data about medical product use, the FDA chief insisted.
Concerns about how the data will be used should not stand in the way of the FDA moving forward with creating the system, von Eschenbach maintained, adding that minor flaws, defects or blemishes should be overlooked for the time being.
"If it isn't a fatal flaw," he argued, "it shouldn't stop us from doing it."
Issues of privacy and scientific accuracy and reliability "will be addressed" by the agency "before the data are used," von Eschenbach assured.
With the potential for a broad range of collaborators to be involved in the Sentinel network, Rosati said, the FDA must consider several privacy questions, such as the HIPAA status of those participants, who will have access to the individually identifiable information and what type of data will be used.
In addition to the HIPAA privacy rules, she said, the FDA also must think about how Sentinel could be impacted by other federal regulations, such as the substance abuse treatment rules.
Those rules, known as Part 2, greatly restrict the ability to use information received from federally assisted alcohol or drug abuse programs for pharmacovigilance, Rosati noted.
States also have their own various privacy and confidentiality laws that could affect access to health data, she added.
In addition to the legal and privacy issues, the FDA must grapple with in establishing Sentinel, McClellan said, it must figure out how results of the data analyses can be communicated effectively to physicians and the public, "not just when there are definitive results, but when there are interim findings, when an association between a drug and a safety problem has been identified or is suspected and is being investigated but not resolved."
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, noted that even after Sentinel is established, the agency will continue to track and analyze data from its other processes for collecting adverse events, such as its AERS spontaneous reporting system, which relies on voluntary reporting from physicians and patients.
Drug firms also will continue to be required to report adverse events to the agency, she noted.
"That's not going to vanish or go away because we have these other ways of getting information," Woodcock said. "It isn't as if we are putting all of our eggs in the Sentinel basket and walking away from these other types of things," she added. | 
