Senate Vote On FDA Reform/PDUFA

Early last week the Senate voted in in favor of a cloture a second timeon the Food and Drug Administration Modernization/Prescription Drug User Fee bill. A spokesman for the Pharmaceutical Research and Manufacturers of America spokesman told the Marketletter that he saw a good possibility of a final vote by the end of the week, largely because Senator Kennedy has been mollifed and now seems willing to proceed.

There were some hard-nosed negotiations; Sen Kennedy got a lot of what he wanted and some honorable compromises were made. The FDA and the patients' groups are on the edge of their seats, the spokesman said, and reported a conversation with someone at the FDA who indicated that the agency should have already sent out about 200 warning notices to employees, as required by law. The FDA is holding off in the hope that PDUFA will be reauthorized, he said, and this urgency is rubbing off on other people; the cornerstone of the bill is renewing PDUFA.

The PhRMA sees no major warning signals from the House version, which was due to be marked up in subcommittee last Wednesday. This is basically a sound bill, said the spokesman; the Democrats are not "screaming," and if Commerce Committee staff member Kay Holcombe says she can live with it, then she is also speaking for John Dingell and Henry Waxman.