(WASHINGTON, DC, October 7, 1997)...Carl B. Feldbaum, president of the Biotechnology Industry Organization (BIO) issued the following statement on the House passage of H.R. 1411. HR. 1411 will modernize the U.S. Food and Drug Administration's (FDA) drug approval process and reauthorize the 1992 Prescription Drug User Fee Act (PDUFA). It combines the three FDA modernization bills on drugs and biologics (H.R. 1411), devices (H.R. 1710) and foods (H.R. 2469). The Senate voted 98 to 2 on a similar bill last week.
"The House of Representatives has joined the Senate today in moving the FDA in a new direction. The FDA's mission will grow under H.R. 1411. Beyond guarding the safety and efficacy of the medicines Americans take and maintaining the highest standards, the agency will now be charged with ensuring that breakthrough medical treatments reach patients expeditiously.
"The overwhelmingly bipartisan support for H.R. 1411 also demonstrates that members of the House join their Senate colleagues in recognizing the importance of keeping the FDA's drug approval system current with the cutting edge biotechnology it regulates."
The Biotechnology Industry Organization (BIO) represents more than 734 biotechnology companies, academic institutions and state biotechnology centers in 46 states and 25 nations. BIO members are involved in the research and development of health care, agricultural and environmental biotechnology products.