FDA launches focus on transparency
Having established its transparency task force the US Food and Drug Administration (FDA) is holding a public meeting today to help understand how the agency “can make understandable and useful information available to the public”.
The FDA has sought feedback from the start of the process, establishing a blog to ask the public how best to structure the meeting and stimulate discussion about what information the agency should disclose and what tools should be used.
Although Deputy FDA Director Joshua Sharfstein has acknowledged that some information may remain confidential the task force’s brief appears to cover areas companies have traditionally considered private.
Whether this will extend to increased publication of information relating to manufacturing data, formulation details or preclinical or clinical research will likely remain unclear until the task force submits its report to the FDA Commissioner.
Establishment of the taskforce is part of President Obama’s openness pledge, which aims to strengthen democracy “by creating an unprecedented level of openness and public participation in government”.
A webcast of the FDA consultation can be viewed here from 7:30am ET.
EMEA seeks input
The European Medicines Agency (EMEA) is also revising its transparency policy and has invited the public to comment on its draft publication.
In the draft policy the EMEA states it will take a more proactive approach to transparency, strengthen interactions with stakeholders and promote discussion with national competent authorities (NCAs).
The EMEA believes “transparency is a pivotal element in building trust and confidence in the agency’s operation”. Previous transparency initiatives have been launched but the EMEA considers this new, single policy “a more robust and consistent approach”.
Comments can be submitted until 25 September, after which the EMEA will hold a workshop to discuss the feedback in preparation for publishing the final document.
The complete draft policy can be viewed here.
