Just two weeks after being sworn in as the Food and Drug Administrations new commissioner, Margaret Hamburg is being prodded to address a number of structural issues dogging the agency including improving transparency, implementing a medical-products-safety surveillance system and modernizing the agencys information technology systems.
... for another its transparency
Hamburg creates task force, GAO issues reports
Those concerns came to the forefront last week when Hamburg announced the creation of a transparency task force and the Government Accountability Office released two reportsone addressing the FDAs plans to implement a post-market medical-products surveillance program called Sentinel and another addressing its efforts to overhaul its outdated IT system.
Hamburg told reporters on a June 2 conference call that the transparency task force was established in response to a Jan. 21 memo in which President Barack Obama directed government agencies to find new ways for making information more readily available to the public. Over the years, there have been complaints made about FDAs lack of transparency, she said. The task forces job, Hamburg added, will be to recommend steps the FDA should take to give the public a more open view.
The two GAO reports came on the heels of Hamburgs response to the presidential transparency directive. The reports each addressed concerns over early-stage progress on two IT-related initiatives. GAO officials concluded that the FDA needs to address security risks to private medical information that will be reported to Sentinel. The GAO also concluded that the FDAs plan for modernizing its IT systems needs to include milestone and performance measures, which the effort currently lacks.
In his written responses to the GAO, former acting Commissioner Joshua Sharfstein, now principal deputy commissioner, agreed with most of the GAOs recommendations for both the Sentinel and IT modernization programs. He expressed concern, however, that the GAOs comments on the Sentinel program could lead some to believe that health information submitted to the surveillance database would be at risk.
FDA officials did not respond to requests for comment regarding Hamburgs strategies for addressing the GAOs concerns. But while such infrastructure issues are an early appearance on the new commissioners to-do list, some agency watchdogs say that they arent the only concerns she will need to successfully address in the nascent days of her leadership.
It makes sense to address important structural issues, but the ones were seeing now are just a piece of the lumberyard, said Jeff Lerner, president and CEO of the ECRI Institute. Lerner says he believes that Hamburg and her top staff will need to quickly focus on policy issues such as the relations between its supervising pre-market product reviewers and industry.
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