FDA modernization; genetic privacy

While the negotiations have been "collegial," BIO President Carl Feldbaum said the negotiators have failed to come to terms on how to modify restrictions on dissemination of information about approved products, the most contentious issue under discussion. However, Feldbaum cited FDA's acknowledgment that the policies need to be modified as a sign of significant progress.

The industry/agency negotiations are intended to develop a consensus that can be taken to Congress, which will have the last word on modernization. Feldbaum said meetings with FDA are scheduled through April, but the two sides are ready to brief lawmakers "as soon as they whistle."...