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FDA task force releases detailed report on proposed disclosure policies
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Yesterday, the FDA’s Transparency Task Force released a report on proposals for increasing the disclosure of information while protecting confidentiality and patient information.
The report was the second phase of the FDA’s Transparency Initiative, which was launched in June 2009 after President Barack Obama called for transparency in federal government agencies.
Among the 21 proposals — the product of more than 1,500 public comments submitted in the wake of two public meetings — are increased access to adverse event reports on regulated products; detailed disclosure of entities subject to inspection; disclosure of the termination or withdrawal of investigational new drug applications and investigational new device exemptions; and public notification of cases in which an application for a designated orphan drug was not withdrawn for safety reasons and that the drug, if approved, may offer significant therapeutic advances.
The proposals also call for the FDA to disclose relevant safety and effectiveness information for an investigational new drug or pending marketing application if the agency deems such disclosure to be in the interest of public health. In addition, one proposal calls for the FDA to disclose when a product recall is terminated.
Joshua M. Sharfstein, MD, FDA principal deputy commissioner and Transparency Task Force chair, and Afia Asamoah, FDA attorney and Transparency Initiative coordinator, reviewed the proposals and fielded questions during a live conference call.
“The proposals reflect what the task force believes is an appropriate balance for the agency to strike between disclosure and confidentiality in support of public health, clinical practice and innovation,” Sharfstein said.
Sharfstein emphasized that the proposals are not final and are subject to further public scrutiny and review by the task force. Some will require changes in law or regulation, and some may require significant resources, he said.
“[The] FDA has not made any final decisions on pursuing these proposals,” he said. “We’re looking for comment on whether we struck the right balance between disclosure and confidentiality, as well as comment on what the priorities of the agency should be in moving forward on transparency.”
The FDA’s Transparency Initiative also includes two online resources: FDA Basics and FDA-TRACK.
The FDA will accept public comment on the proposals for 60 days.