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designated orphan drug was not withdrawn for safety reasons and that the drug,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. ADVERTISEMENT
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.
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