FDA Transparency Task Force unveils draft proposals for more public disclosure relating to pharma; agency to appoint biosimilars director

The US Food and Drug Administration's Transparency Task Force yesterday released 21 draft proposals for public comment on public disclosure policies aimed at helping consumers, stakeholders and others understand how the agency operates and makes decisions. The Transparency Task Force will review the comments and decide which proposals to recommend for implementation.

The Task Force was set up last summer in response to US President Barack Obama's call for 'an unprecedented level of openness in government'(The Pharma Letter June 3, 2009), and after the FDA previously came under significant criticism from doctors, consumers and lawmakers for failing to disclose risks associated with several drugs that it had approved.

The proposals, to be published in the May 21, 2010, Federal Register, are part of the second phase of the FDA's Transparency Initiative launched last summer by FDA Commissioner Margaret Hamburg.