Tom Harkin: “again, we are on the Food and Drug Administration Safety and Innovation Act of 2012. As the chair just said, we have 6…”

“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.…”