Food and Drug Administration Reform Act of 2012

Floor Speech

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Mr. BURGESS. I thank the gentleman for yielding.

Mr. Speaker, this is not a perfect bill, but it's a good bill, and it's a solid bill. It is worthy of the support of everyone on this floor. This bill reauthorizes the FDA's user-fee programs for prescription drugs and medical devices and, in fact, authorizes two new programs for generic devices and what are known as biosimilars. Together, all of these products provide powerful tools to prevent and alleviate human suffering.

The Food and Drug Administration must have the infrastructure and the resources to ensure patient safety and to approve new products in a straightforward and predictable fashion. Delayed reviews increase costs, hurt innovation, cost jobs, and deny patients potentially lifesaving products. These agreements present the tremendous opportunity to ensure that we have a strong and efficient FDA, and the committee responded appropriately and seized that opportunity. This bill will help the FDA build on what's working, address what isn't, and provide resources to meet future goals.

With the ranking member on the subcommittee, Mr. Pallone, we crafted new guidelines for how the Food and Drug Administration recruits, approaches, and accesses relative scientific and medical expertise. I'm also pleased that we require the Food and Drug Administration to now notify Congress before issuing guidance regarding the regulation of laboratory-developed tests. We still need to strengthen and improve the oversight of laboratory-developed tests instead of promoting duplicative regulation that delays access to lifesaving diagnostics, but it's a good first step. Additionally, the bill takes good first steps to address critical drug shortages. No physician wants to tell a patient they can't receive the care that they need because the product is unavailable.

The process was respectful and resulted from hundreds of hours of negotiation. Certainly, Chairman Pitts and Ranking Members Waxman and Pallone and Chairman Emeritus Dingell and their staffs should be given tremendous credit, along with Ryan Long and Clay Alspach for the work they did on the majority staff, and my personal staff, J.P. Paluskiewicz, who put in long hours to get this product to the floor.

This vote is about patients. We need to get it right for them, and I think we've come awfully close to getting it right.

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