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Jun 07, 2010
 |  BioCentury  |  Regulation

Seeking Clarity on Transparency

Investors, drug developers may not align on FDA transparency proposals

Draft transparency proposals released by an FDA task force would, if implemented, give the public, investors, competitors and researchers unprecedented insight into both the agency's decisions and the reasons it makes those decisions.

The most controversial proposal is to publicly release complete response and refuse-to-file letters for drugs and biologics, and not approvable letters for devices, at the time they are sent to sponsors.

FDA also is considering asserting its authority to disclose summary information from INDs and pending NDAs and BLAs "if disclosure is in the interest of the public health," including to correct misleading information about a product.

Other proposals include publicizing information about INDs and IDEs, such as when applications are submitted, as well as when and why they have been placed on hold or a hold has been lifted (see "Key Transparency Initiatives").

The proposals have revealed splits between big and small companies, with the Pharmaceutical Research and Manufacturers of America (PhRMA) categorically rejecting many of the task force's ideas about revealing more information about product applications and the Biotechnology Industry Organization (BIO) expressing an interest in discussing how to reconcile greater transparency with the protection of trade secrets.

FDA is accepting public comments on proposals made by FDA's Transparency Task Force and conducting internal reviews of its legal authority to institute them and the resources that would be required, according to Joshua Sharfstein, principal deputy commissioner. Information that could reveal trade secrets would be redacted, he said on a...

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