Included in this Alert:
- Overview of FDAAA
- Notable FDAAA Provisions
Excerpt: Overview of the Food and Drug Administration Amendments Act of 2007
The Food and Drug Administration Amendments Act of 2007 (FDAAA) arguably constitutes the most significant reform of the domestic regulation of prescription drug safety since enactment of the 1962 Drug Amendments, better known as the Kefauver-Harris Amendments.
After weeks of intense preconference negotiations between House and Senate staff, on September 19, 2007, the House passed H.R. 3580, the Food and Drug Administration Amendments, under suspension of the rules. The final vote was 405-7 in favor of passage, with five Republicans and two Democrats voting against the bill.
On September 20, the Senate took up the House legislation and passed it by unanimous consent. Congress acted expeditiously on the legislation in order to reauthorize several critical user fee-funded programs by September
30 and forego the Food and Drug Administration (FDA) having to issue an estimated 2,000 “reduction in force” (RIF) notices.
While the scope of the final legislation is similar to the Senate and House bills passed in May and July respectively, significant differences were resolved in the preconference discussions. FDAAA encompasses four reauthorizations vital to the prescription drug and medical device industries, establishes important new regulatory authorities affecting the food industries, and addresses many other significant regulatory issues across a broad scope of reform.
Passage of the bill is a major health-related accomplishment for Congress, which is working actively on other “must-pass” healthcare legislation, including reauthorization of the successful State Children’s Health Insurance Program (SCHIP).