Political Quotes

“3 years of hard work, which was begun by Senator Nancy Kassebaum, have resulted in the passage of the conference report to the Food and Drug Administration Modernization Act of 1997 in the Senate today. This legislation represents the first major, comprehensive reform effort since the initial amendments outlining regulation for drugs in 1962 and for medical devices in 1976. This major reform will help improve the FDA by strengthening its efficiency, accountability, and its ability to safeguard the public health. There are several provisions contained in this bill that constitute significant reform and improvements to increase the efficiency of product review. For example, this legislation gives FDA authority to increase its access to scientific and technical expertise outside the Agency by allowing interagency collaboration with Federal agencies such as the NIH and CDC, and with the National Academy of Sciences. Also, the bill gives FDA the explicit authority to contract with outside reviewers and expand its current third party medical device review pilot program. To help alleviate the confusion and frustration that many applicants feel when working with the FDA, the bill will require the FDA to codify evidence requirements for new drug and medical device application submissions and encourages improved communication between the agency and industry.”