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Public Statements

Food and Drug Administration Reform Act of 2012

Floor Speech

Location: Washington, DC


Mr. PITTS. Mr. Speaker, 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.

When we began considering this legislation last year, we heard from a number of individuals involved in the medical device industry about the increasing difficulty of working through the review process. American patients were waiting almost 4 years longer for new devices that had already been approved in Europe, and despite the slow review process, the safety outcomes were comparable.

The FDA Reform Act contains critical reforms to the Medical Device User Fee Act which will hold the FDA accountable and keep the reviews on schedule. Under the fourth version of the Prescription Drug User Fee Act, the median time of approval was 9 months. With the reauthorization, we set the goal of reducing the review time to 8 months. Currently, generic drugs have an average approval time of 32 months. Included in this legislation is a new user-fee program that should be able to gradually reduce review times to 10 months for most products. A separate user-fee program for biosimilars has the goal of 10-month approval times for most products. Finally, we also include language to help patients, doctors, and hospitals to deal with drug shortages.

Mr. Speaker, I am proud of the work we have done here. I would like especially to thank full committee Chairman Upton as well as Health Subcommittee Ranking Member Frank Pallone, full committee Ranking Member Henry Waxman, and their staffs for patiently working with us on the FDA Reform Act.

This is legislation to help save lives and create jobs, which are two goals that we can all agree on. It is a bipartisan effort, and I urge all Members to support the legislation.


Mr. PITTS. Mr. Speaker, in conclusion, I want to again commend leadership on both sides of the aisle: Ranking Member Emeritus Mr. Dingell and Ranking Member Mr. Pallone and Mr. Waxman and Chairman Upton and staff of both sides. They have done a terrific job and spent countless hours. I especially want to mention Clay Alspach and Ryan Long on our side, as well as our personal staff. They have been absolutely terrific. Because of this, this legislation is going to save many lives. It's going to help the United States continue to be the world leader in the pharmaceutical and medical device industries and mean a lot to our economy as well.

I urge all Members to support this very important legislation, and I yield back the balance of my time.


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