Progress On US Senate And House FDA Reform Bills

The Clinton Administration has urged changes in the Senate version ofthe US Food and Drug Administration reform bill, including removing the provision for medical device testing, but said the final bill represents a significant step toward accomplishing the mutual goal of assuring the agency's optimum performance while protecting the health of the US people.

Labor and Human Resources Committee chairman Senator Jeffords noted that the White House has not so far used the word veto, and remains confident that President Clinton will sign the final bill once it is worked out by the Senate and the House.

The bill is one of the most important in the short history of the biotechnology industry, said Biotechnology Industry Association head Carl Feldbaum, adding that it is bipartisan, moderate and much-needed. However, Public Citizen president Joan Claybrook said the Senators who voted for the bill voted for more drug disasters like fen/phen and more medical device tragedies. Voters can see clearly which Senators think industry profits are more important than public health, she added. As for the off-label use provision, Maura Kealey of Public Citizen said this is the first time in US history that drugs that have not been proved safe and effective will be legally marketed.