Experts speaking on behalf of Roche/Genentech's Avastin for use in breast cancer patients won't be required to disclose financial ties after the presiding officer of next week's hearing on the issue rejected an FDA request for greater transparency. The agency had petitioned presiding officer Karen Midthun, maintaining outside scientific experts should be required to disclose any financial ties to Roche or any companies making meds that compete with Avastin.
As Bloomberg notes, the decision is a victory for Roche, which is appealing the FDA's Dec. 16 proposal to withdraw the medicine's 2008 conditional approval for breast cancer.
In the petition signed by CDER's Carla Cartwright and Abby Brandel, the agency points out that the members of the presiding committee are required to disclose any financial interests related to the subject matter of the meeting. In fact, the presiding officer, the committee and the public are aware of any potential conflicts for all scientific experts at the meeting--except for those appearing on behalf of Genentech. However, Midthun said the agency's request proposal has no basis in regulations and isn't justified, Bloomberg notes.
"It will be apparent to all concerned that these presenters are appearing on behalf of Genentech," Midthun said in her response. The FDA can cross-examine the speakers about their financial ties if the agency "is concerned that there are additional financial interests that affect the credibility of the opinions advanced by the Genentech presenters," she said, as quoted by Bloomberg.