PhRMA Press Briefing On FDA Reform/PUDFA

With the earlier 89-5 Senate vote on US Food and Drug Administrationreform/PDUFA reauthorization bill that allowed the Senate to move to debate on the bill, there is now sense of inevitability, according to Pharmaceutical and Research Manufacturers of America President Alan Holmer, who noted (ahead of the final vote) that it is clear that Senate Labor Committee chairman Jeffords and his co-sponsors have the votes to pass the bill with the manager?s amendment.

PDUFA is the most successful industry-government partnership ever, Mr Holmer told those attending a press briefing, noting that there also is a strong commitment to PDUFA in the House. House Commerce Committee chairman Rep Bliley has said that his top priority in September is to get the reauthorization of PDUFA and FDA reform accomplished. PhRMA information is that the subcommittee markup is scheduled for September 11 or 16, and full committee markup coming on the 18th. This augurs well for getting the bill approved by both Houses before the end of September, Mr. Holmer said, noting his surprise in reading comments made by Mr Schultz at the recent FDLI advertising and communications meetings that all this should be accomplished in the October 15-November 1 range. PhRMA is extremely upbeat after the earlier 89-5 vote, and feels there is no reason why this can not all be done by October 1, when PDUFA runs out. The House schedule seems consistent with getting things accomplished by the October 1 deadline.

While there has been some criticism that the Senate bill will weaken the standards for drug approvals, as well as criticisms regarding provisions on the dissemination of off-label information or health care economic information, Mr Holmer said there is no one in the Senate that shares those concerns. These arguments lack merit, he said, noting that the fact that neither Senator Kennedy nor other Democratic members on the Labor Committee have problems with these items gives some assurances that there is support for the current bill.