Today, Senator Tom Harkin (D-IA) and Senator Mike Enzi (R-WY), Chairman and Ranking Member of the Senate Health, Education, Labor and Pensions Committee, heralded final passage of the Food and Drug Administration Safety and Innovation Act (S.3187), bipartisan HELP Committee legislation that would ensure that the FDA can approve drugs and medical devices, save biomedical industry jobs, protect patient access to new therapies, and preserve America's global leadership in biomedical innovation. The legislation, which was approved by the Senate by a vote of 92 to 4, now goes to President Obama for his signature. Senators Harkin and Enzi made the following joint statement after the vote:
"Approval of the Food and Drug Administration Safety and Innovation Act is the result of nearly two years of bipartisan cooperation and hard work. This bill is a great example of the kind of progress we can achieve when we work together, and we are grateful to all of our colleagues for their efforts in this process. This legislation will help bring critical drugs and medical devices to market faster, protect patients from drug shortages and manufacturing problems, and enhance the availability of low-cost generic drugs. It will also help patients with rare and very rare diseases obtain access to effective therapies more rapidly. It will help the FDA do its job more effectively, increasing accountability and transparency, so U.S. companies can innovate and compete in the global marketplace.
"While people like to talk about polarization and gridlock in Washington, this bill is a victory for both bipartisanship and for the millions of American who rely on medicines and medical devices."