On the recordMay 30, 2012
The Food and Drug Administration Reform Act of 2012 is a product of nearly a year and a half of work in the Energy and Commerce Health Subcommittee. H.R. 5651 is the result of bipartisan negotiations. The bill passed out of the Health Subcommittee by a unanimous voice vote and passed out of the full committee 46 0. I would especially like to thank Clay Alspach, Ryan Long, and Paul Edattel and the other staffers for their dedication and hard work in making this bill possible. I know they've put in a lot of hours; and because of that work, we have brought this bill to the floor in a timely manner. The FDA Reform Act is critical to saving lives and sustaining a dynamic American industry. American companies are the leading developers of new medical devices and drugs to save and sustain life. To ensure that products are both safe and effective, we've tasked the Food and Drug Administration with reviewing products before they make their way into the market. This is a big job. The device and drug industries are dynamic and innovative. Companies spend tens of millions of dollars and years of work to develop products. The review stage is a critical time for any company. Inconsistent reviews mean that the true cost of developing a new product is hidden, making it difficult to properly prepare.…
Source
govinfo.gov




