Found this in the mouse maze! Patient last to know.

 Being a patient advocate is like running in a maze designed to disorient and exclude.

Regina Holliday (patient advocate, artist) painted this while attending the PCORI patient-engagement workshop in DC today.  It is unreasonable of PCORI/FDA to expect any patient or advocate to demonstrate more tenacity or willingness to work productively.  This system is rigged.  I await my invitation to the December 4 PCORI meeting.

FDA PushesDevice Surveillance Plan That Could Involve PCORI; Off-Label, Data Access Debated

Posted: September 11, 2012  (FiDA highlight)

FDA device officials are pushing for a national postmarket surveillance monitoring system that emphasizes Unique Device Identifiers and their incorporation into electronic health records, device registries, modernized adverse event reporting and new methods to analyze postmarket information, laying out the plan in a paper released late last week and discussed at a public meeting Monday (Sept. 10). The head of the health law's comparative effectiveness institute expressed interest in participating in the initiative, which FDA hopes will extend beyond the agency.

Stakeholders also debated potential governance structures, eventually floating a public-private partnership. When pressed on the role the health law's Patient-Centered Outcomes Research Institute could play, PCORI Executive Director Joe Selby said he is particularly interested in involving patients and contributing analytic methods. “We’d be glad to be party to discussions like that,” he told and FDA official during the meeting. He said, however, there should be a business case made to each party, and it is more challenging to make the case for patients and health systems.

While industry, consumer and academic stakeholders lauded FDA’s effort, concerns emerged about off-label uses and access to the data, given issues with patient protections and company proprietary concerns. “The key is going to be implementation,” said Paul Brown, government relations manager with the National Research Center for Women and Families. He cited examples in the report that spurred concerns about the potential to incentivize off-label use as the data collected through postmarket surveillance could support new indications.

“Analysis of de-identified EHR data containing a unique device identifier demonstrates that within the practice of medicine, physicians have been treating patients with incontinence due to other causes -- and the data demonstrates the device is as effective as it is in patients with incontinence due to prostate surgery,” according to an example comparing potential future uses of the system to the current state where manufacturers must conduct clinical trials to expand labeled indications. “The company submits the analysis and (the Center for Devices and Radiological Health) approves an expansion of the labeled indication solely on the basis of the collected postmarket data.”

Brown warned that, depending on implementation, the system could provide an incentive for companies not to conduct clinical trials and potentially exacerbate problems with off-label promotion. Another device safety advocate, however, said using the postmarket data would allow for a real-world analysis of devices as many risks are unknown until products are available to a broader patient population.

Brown also took issue with FDA suggestions that postmarket data could be used in support of device down classifications, saying such information should also be used to support up classification if appropriate. Further, he said FDA should have access to information in registries to detect safety signals, an issue that also emerged as academic and industry stakeholders debated who would have access to the device data as it could affect hospitals and individual practitioners. Industry stakeholders also expressed concern that the system should not try to be “all things to all people.”

FDA device center director Jeffrey Shuren emphasized that the agency would leverage national and international registries, as opposed to creating a registry repository.

“Let me be clear, we don’t need registries for every type of medical device nor is it feasible or sustainable to do so,” he said. “And we don’t want to develop a central repository.” Individual repositories should remain such as it helps protect patient privacy, he said.

Thomas Gross, director of the device center’s office of surveillance and biometrics, said the agency has already facilitated the development of dozens of registries. With regard to modernizing adverse event reporting, Gross touted the use of triggers in electronic health records to automate the reporting and a medical app that is being piloted.

FDA device officials said they hope to release a finalized version of the plan by the end of the year. -- Alaina Busch (abusch@iwpnews.com)