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Food and Drug Administration Safety and Innovation Act of 2012 -- Continued

Floor Speech

By:
Date:
Location: Washington, DC

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Mr. HARKIN. Mr. President, again, we are on the Food and Drug Administration Safety and Innovation Act of 2012. As the chair just said, we have 6 hours 15 minutes of debate time. I am hopeful we don't utilize it all and that we can vote on this sometime later this afternoon.

We just considered this bill in the Senate a few weeks ago and passed it 96 to 1. Following the conference with the House, the House passed the bill unanimously last week. Today I trust that we will finish the job.

I am genuinely proud of this legislation. It will ensure that the FDA has the resources to speed market access to drugs and devices while continuing to ensure patient safety. For the first time, it will make new resources available to allow the FDA to clear its backlog of applications for generic drugs, which will help ensure that patients have access to less expensive medications. It will make sure the FDA has the funds to prevent there ever being a backlog in applications for biosimilars. These resources are vital to FDA's ability to do its job, to the medical products industry's ability to make these products and, most importantly, to patients who need both access to drugs and devices, and assurances that they are indeed safe.

This legislation has benefited from input from a diverse range of interested parties, Senators on both sides of the aisle, our colleagues in the House, industry stakeholders, consumer groups, and patient groups.

Over 1 year ago the parties started bringing policy ideas to the table. We worked together in bipartisan working groups to reach consensus on these policy measures. Where we could not achieve consensus, we didn't allow those differences to distract us from the critically important goal of producing a bill that could be broadly supported. As a result of this bipartisan process, we have a bill that advances our shared goals of patient safety, patient access, a well-functioning FDA, and strong and viable American businesses. We streamlined the device approval process while also enhancing patient protections. We modernized FDA's authority to ensure that drugs and drug ingredients coming to the United States from overseas are safe and to ensure that our domestic companies compete on a level field with foreign ones. We addressed the critical problem of drug shortages. We helped spur innovation and incentivized drug development for life-threatening conditions. We reauthorized and improved the incentives for studying drugs in children.

Finally, we increased accountability and transparency at FDA. So the bill strikes a balance. It will help keep our regulatory system in pace to adapt to technological and scientific advances. It will create the conditions to foster innovative advances in medical technologies. Again, it will do all of this without losing sight of the most important function of the FDA--ensuring patient safety.

So it has been a long road leading up to this moment. We have been working on this bill for well over 1 year and 3 or 4 months with the help of Senators on and off the committee.

Again, I thank my colleague, the ranking member of the Health Committee, Senator Enzi, for all of his diligent and hard work and that of his staff for helping to bring all the different parties together and making sure we had a consensus bill that responded to all of those inputs.

So we have had a great collaboration. I think we have an excellent bill. Again, I am hopeful we can have our comments and discussions this afternoon, but I urge all my colleagues to vote today to pass the FDA Safety and Innovation Act. It is critically important to the agency, the industry, and to the patients we get this done. This will be the final step.

As I said, the House passed it unanimously. If we pass it today, it can go to the President for his signature as soon as we pass it this afternoon.

Mr. President, I yield such time as he may consume to my good friend and colleague and ranking member, Senator Enzi.

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