To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the animal drug user fee program, to establish a program of fees relating to generic new animal drugs, to make certain technical corrections to the Food and Drug Administration Amendments Act of 2007, and for other purposes.

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 6432) to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the animal drug user fee program, and for other purposes, as amended.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days to revise and extend their remarks and include extraneous material on the bill under consideration.

Mr. Speaker, I yield myself such time as I may consume.

Prior to 2003, the FDA's review of animal drug submissions was taking over a year and a half to be completed. This obviously led to serious concerns that new and innovative pharmaceutical products were not making their way onto the marketplace in order to treat our Nation's pets, as well as food animals that help sustain the Nation's food supply.

Accordingly, in 2003, Congress enacted the Animal Drug User Fee Act (ADUFA) which was modeled after the successful user fee programs for the review of human drug and medical device submissions. Like the user fee programs that preceded it, ADUFA authorized the FDA to collect fees to help ensure that the agency had the resources it needed to provide a timely review of animal drug applications.

The legislation before us today would reauthorize the ADUFA program for another 5 years. Under this legislation, the amount of fees collected for the review of animal drug submissions would increase from $15 million to $24 million over 5 years, for a total of $98 million. Revenues would be derived from a mix of application, product, establishment and sponsor fees.

The legislation would also improve the uniform collection and reporting of data to FDA on the sales about animal drugs that contain an antibiotic ingredient.

During the debate on reauthorization of ADUFA, we heard many concerns about the use of antibiotics in animal populations for non-therapeutic purposes and the threat that these practices pose to human health. This bill includes language that would enhance FDA's current data collection by creating a new antimicrobial animal drug use data report for all food-producing animals. The report puts critical information in one place for FDA; otherwise, the agency would have to search through warehouses of multiple paper reports.

In addition to the reauthorization of ADUFA, this legislation would establish a new animal generic drug user fee. According to FDA, the average review time of an animal generic drug submission was 570 days in Fiscal Year 2007, in spite of a 180-day statutory requirement. At the end of last year there was a recorded backlog of 446 submissions waiting for review and agency action.

Accordingly, the bill before us would provide for the collection of user fees increasing annually from $4.8 million to $6 million over 5 years, for a total of $27 million. And these additional revenues are designed to help speed up the review process. By Year 5 of the authorization period, most reviews of generic animal drug submissions should occur in 270 days or less, a substantial improvement over the time it is now taking FDA to conduct such reviews.

Mr. Speaker, I am also pleased that the generic drug industry and FDA have been able to work out this agreement. If enacted, AGDUFA will speed lower cost animal drugs to the marketplace and bring significant savings to ranchers, farmers and pet owners. While that is an important and noteworthy goal, I also think it is equally, if not more important, to ensure for the timely review of generic human drug applications.

There is a provision in this bill that would improve the speed in which FDA reviews generic drug applications, and that provision makes a technical correction to the Food and Drug Administration Amendments Act of 2007 as it relates to the application process for obtaining FDA approval of certain new generic drugs.

Citizen petitions can be submitted to FDA to raise issues about drugs that are being considered in the application process. At the time of negotiations on the Food and Drug Administration Amendments Act of 2007, an agreed-upon sentence was inadvertently dropped from our final version of that bill. The sentence makes clear that consideration of a citizen petition regarding a drug is to be separate and apart from review and approval of any application for the drug. The language included in the bill we are considering today restores that sentence.

There is another correction to the FDA Amendments Act that is included in the bill before us. This change concerns the types of information to be included in the clinical trials data bank established under that law. More specifically, the issue is adverse event information on drugs and on medical devices.

Adverse event information was clearly intended to be included in the data

bank for both drugs and devices. Express specific requirements to that effect were included in multiple drafts of the legislation. In negotiations, however, it was agreed that rather than the bill itself including express specific requirements regarding adverse event information, the FDA would issue regulations that would set the specific requirements. In drafting the ``regulations'' approach, the reference to medical devices was inadvertently dropped, and that was a simple mistake. So the bill before us today corrects that mistake.

In closing, I want to thank my Republican colleagues for working for us in a bipartisan fashion to move this bill forward. Mr. Deal, Mr. Barton and of course Mr. Dingell all worked together, so this is, in fact, a bipartisan bill, and a very important bill as well.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I am pleased to yield 3 minutes to the gentleman from California (Mr. Waxman) who, I must add, has been such an outstanding spokesman on FDA issues over the years, and particularly promoting generic drugs. I yield to the gentleman 3 minutes.

Mr. Speaker, I yield myself such time as I may consume.

I just wanted to say that I understand the gentleman's concerns who just spoke, Mr. Buyer, the gentleman from Indiana, and I, too, am very concerned about counterfeit drugs entering the U.S. marketplace. I think the FDA should have the authority to seize and destroy counterfeit drugs. And as the gentleman knows, we are working with him to address this issue in a larger bill that will empower the FDA to protect the consumers from dangerous products, including counterfeit drugs. So I hope that we can continue to work with the gentleman on this matter.

I yield to the gentleman from Indiana.

Mr. Speaker, I certainly heard what my colleague from Indiana said, and I'm certainly willing to work with him on what he's suggesting.

I reserve the balance of my time.

Mr. Speaker, again, I want to thank my colleagues on both sides of the aisle for their support of this legislation and urge that it be adopted.

I yield back the balance of my time.

Mr. President, I rise today in support of H.R. 6432, a bill that reauthorizes the Animal Drug User Fee Act, or ADUFA, and create a new user fee for the approval of generic animal drugs. This bill also addresses the use of antibiotics in animals, and technical corrections to last year's Food and Drug Administration Amendments Act.

Like human drugs, animal drugs must be shown to be safe and effective before they can be marketed. An animal drug can take 7 to 10 years to develop, at a cost of $100 million or more. ADUFA supports the review of animal drugs by authorizing FDA to collect fees for animal drug applications, and for the establishments, products, and sponsors associated with these products.

This program is similar to the user fee programs for human drugs and medical devices which we renewed last year. Like those programs, ADUFA expires October 1. If we do not act on this bill, 60 valuable FDA employees could be laid off. Even if we simply delay renewal of this program, those employees will receive a ``reduction in force,'' or RIF notice, indicating they might be let go. Many will make that possibility a reality, and leave the agency, taking their talent with them.

ADUFA has been a success. The program has eliminated the review backlog for new animal drugs, improved the timeliness and predictability of reviews, and improved communication between companies and the FDA throughout the process. The renewal of this program will continue to enhance FDA review capacity, including more support for increasingly complex reviews. Also, there is a growing backlog of premarket inspections of foreign animal drug producing facilities, which is a very timely issue. The renewal of ADUFA would better prioritize those inspections, and eliminate the backlog, helping to keep our animal drug supply safe.

The renewal of this important animal health program would nearly double funding levels to $98 million over 5 years. I want to be clear that the renewal of this program does not speed up the review of new animal drugs. It holds FDA to the same performance goals for review times--it just keeps review times from getting slower.

The bill we are considering today contains another important advance for animal drugs. Under the Food, Drug and Cosmetic Act, FDA is required to review and act on generic animal drug applications within 180 days. Unfortunately, in fiscal year 2007, the average review time for generic animal drug applications was 570 days, and there was a backlog of 446 of these submissions. Without Congressional action,

the proposed target for action in fiscal year 2009 is 700 days--nearly 2 years. This is an untenable position.

We all know that FDA is seriously underfunded. Like many of you, I would prefer that appropriations be used to fund the agency's activities. But that is simply not in the offing. An appropriated dollar is better than a user fee dollar, but a user fee dollar is better than no dollar at all. The Animal Generic Drug User Fee Act under consideration today would create a new program to fund the reviews of animal generic drugs. This program will lead to progressive improvements in performance, with the time for review and action on submissions decreasing each year.

If we do not proceed with this initiative, our farmers, ranchers, veterinarians and pet owners like you and me will not be able to capture the savings that result from generic animal drug use. I want to point out that even with the creation of this new user fee, the performance goals do not return animal generic drug review times to the statutory requirement of 180 days. By fiscal year 2013, the fifth year of the program, the proposed review target is 270 days. Once again, the best we can do is to keep things from getting much worse as quickly.

The bill before us today also includes a section expanding and streamlining the reporting of the amount of antibiotics that are used to treat animals that are sold annually and the label information about those antibiotics. This reporting language is a carefully crafted compromise between the farmer, rancher and veterinarian communities on one side and those who think the FDA has inadequate information to assess the potential public health impact of antibiotic use on the other. I appreciate the House Members and staff and outside groups who worked together to achieve this agreement.

Finally, this bill contains just two of several changes necessary to properly implement the Food and Drug Administration Amendments Act of 2007. As with any large piece of legislation, there are some technical corrections necessary to fix inadvertent errors in the law.

These technical corrections are critical to ensuring that key drug safety and transparency provisions in the bill work as intended. I am disappointed that we could not complete agreement on a package in time to attach the package to ADUFA. I am even more discouraged that the House chose to cherry-pick just the technical corrections they wanted and attach those instead.

But given the approaching deadline for renewing ADUFA, we cannot afford to hold this important program hostage to unrelated provisions. I intend to continue pressing for passage of a full package of technical corrections. I appreciate Chairman Dingell's commitment to continuing to meet and work on this, and I look forward to preparing a full package of technical corrections that can be accepted by both Houses and go into effect.

I thank my colleagues for their hard work on these proposals. We have some work still ahead of us, but the bill before us today contains much that is good. I strongly urge my colleagues to support final passage.

Mr. Speaker, I need to discuss an amendment that was adopted at the committee that is not in this bill today. We, as a country, are facing a tremendous challenge, and that is, with the advent of the Internet, it is very easy for people to get on the Internet; they go to a Web site and they believe that they can order drugs and that the drugs that they order on the Web site can be the very same drugs that they get down at the CVS or the Walgreens or the local community pharmacy.

Every time the FDA does an inspection at our international mail facilities, they discover anywhere from 67 to 90 percent of the drugs that are coming in from the orders of these mail sites, are either adulterated, misbranded or counterfeit drugs.

Now, let's just do the math. Every day, 20 to 30,000 packages, pharmaceutical packages enter each of our 12 international mail facilities every day. The FDA only screens less than 1 percent.

Now, let's think about this. Just take 30 days, for a month, times 400,000 packages, you get 12 million, times 12 months, that is 144 million pharmaceutical packages.

Now, do the math with regard to the number that are either misbranded, adulterated or counterfeit. Now, let's just do really simple math, and just say, okay, we will give a little flexibility in there. That is 100 million pharmaceutical packages that are either adulterated, misbranded or counterfeit. We have a very, very serious problem. Now, that is with regard to the human consumption.

Now, you are saying, Steve, what does that have to do with the Animal Drug Fee User Act here today?

Well, what I had hoped to do is, it is only a matter of time before the bad actors of the world enter this economic space, meaning, if they can scam the American people with regard to human consumption, you know what? It is really going to be easier for them to do this in the animal drug business because you are never going to know why that animal died.

We have a tremendous challenge. The FDA feels that they do not have the authority to destroy these misbranded, adulterated, or counterfeit drugs. So what's happening? You go to an international mail facility. When Customs finds one of those packages, they'll destroy it, but if that package then gets referred to the FDA, FDA feels that they do not have the legal authority to destroy that package.

Now when they feel they don't have the legal ability to destroy, they have adopted a ``return-to-sender'' policy.

Now let's think about this. The bad actors of the world, the counterfeiters and the criminal syndicates, are very sophisticated as to how they move these counterfeit packages from country to country to gain access into our marketplace. Then when we discover that package, the FDA, through their policy now, returns it to the counterfeiter. Think about that. Our own FDA that is there to protect us then becomes the enabler of the counterfeiter. So the counterfeiter takes the person's money and we return the merchandise that's counterfeit to the counterfeiter.

Now that is stupid. That's about as idiotic as I have ever seen.

So what did I attempt to do? Well, we're working on a food and drug safety bill in the committee, and I appreciate the gentlemen's work on both sides of the aisle. It's on human consumption. So what I had hoped to do here was say, Well, let's stop these bad actors and the criminal syndicates and the counterfeiters from entering into animal drugs. Chairman John Dingell agrees with that provision, and it was going to be in here.

The Democrat leadership said, ``No. We can't have that in this bill.'' Now that's a curious and puzzling thing. But what I will say is, and my agreement with Chairman Dingell is that this is an issue as a country in matters of food and drug safety that we, as Republicans and Democrats, must come together to protect the American people and to go after these bad actors around the world, the criminal syndicates who are preying upon America's most vulnerable populations. We have to enjoin together to do this. And that's my pledge to work with Chairman Dingell and Joe Barton and other members of the committee, and I salute Mr. Matheson, for us to do this so not only do we bring protections on the animal side to go after the bad actors, we put protections in place on the human side. And we can do that not only in stopping the bad actors but also including electronic pedigree, and I will work with you to do just that.

Will the gentleman yield?

In my conversations with the chairman, not only last night but also this morning, I will work with the gentleman to make sure that we can have this in the drug safety bill not only on humans but will also protect animals, so we will give the authority to the FDA to destroy. I will work with the gentleman.

But we also brought up in the conversation--I understand that a little pain could have been created here today. I want to work with the majority. In other words, they weren't forced to go through the Rules Committee and then we have a big fight on the floor. I agreed with the chairman. We withdraw the amendment.

But I want to work also--please work with Mr. Matheson and I on the electronic pedigree. It builds off of Chairman Dingell's paper pedigree so we can sophisticate America's systems for American people here as we also then fight the counterfeiters who are trying to gain access into our market. And I'll work with the chairman to do that.

Mr. President, on August 1, 2008, the Senate passed H.R. 6432, the Animal Drug User Fee Amendments of 2008. Title I of this bill includes the reauthorization of the FDA's animal drug user fee program, while title II of this bill establishes the FDA's generic animal drug user fee program.

Performance goals, existing outside of the statute, accompany the authorization of animal drug user fees and animal generic drug user fees. These goals represent realistic projections of what the Food and Drug Administration's Center for Veterinary Medicine can accomplish with industry cooperation. The Secretary of Health and Human Services forwarded these goals to the chairmen of the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate, in documents entitled ``Animal Drug User Fee Act Performance Goals and Procedures'' and ``Animal Generic Drug User Fee Act Performance Goals and Procedures.''

According to section 101(b) of H.R. 6432, ``the fees authorized by the amendments made in this Act will be dedicated toward expediting the animal drug development process and the review of new and supplemental animal drug applications and investigational animal drug submissions as set forth in the goals identified, for purposes of part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate as set forth in the Congressional Record.''

According to section 201(b) of H.R. 6432, ``the fees authorized by this title will be dedicated toward expediting the generic new animal drug development process and the review of abbreviated applications for generic new animal drugs, supplemental abbreviated applications for generic new animal drugs, and investigational submissions for generic new animal drugs as set forth in the goals identified in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate as set forth in the Congressional Record.''

Today I am submitting for the Record these documents, on behalf of Senator Kennedy, who could not be here today, which were forwarded to the Committee on Health, Education, Labor and Pensions on July 30, 2008, as well as the letter from Secretary Leavitt that accompanied the transmittal of this document.

I ask unanimous consent to have material printed in the Record.

Mr. Speaker, I rise in support of H.R. 6432. Today we consider important public health legislation that, in the best tradition of the Committee on Energy and Commerce, has strong bipartisan support as well as backing from industry, consumer, and stakeholder groups.

I note that this bill has three titles--each representing different bills considered by the Committee on Energy and Commerce. The first title is the ``Animal Drug User Fee Amendments of 2008''. This title reauthorizes a successful user fee program that has allowed the Food and Drug Administration (FDA) to safely and efficiently review animal drugs. This part of the bill improves the existing program by increasing fee revenues, providing greater transparency, and setting specific timeframes by which data must be submitted to the FDA.

This title of the bill also contains provisions related to the issue of antimicrobial resistance. The Committee worked closely with Members from both sides of the aisle, as well as industry and consumer groups, to ensure that the FDA has the necessary information to examine safety concerns related to the use of antibiotics in food-producing animals. I commend Representatives Matheson, Waxman, Pallone, Deal, and Barton for reaching agreement on this important public health concern.

The next title is the ``Animal Generic Drug User Fee Act of 2008'' (AGDUFA). This program is similar in design to the ADUFA program, but with a specific focus on expediting the review of applications for new generic animal drugs.

A key component of both ADUFA and AGDUFA is additional resources for FDA to protect the public health. The lack of resources for the FDA has been a major focus of the Committee. I intend to address this issue more broadly in legislation being drafted with Representatives Barton, Deal, Pallone, Shimkus, Stupak, and others, that will significantly improve and enhance our food and drug safety system.

The third and final title makes two technical corrections to public law 110-85, the Food and Drug Administration Amendments Act of 2007. The first correction addresses an implementation problem related to the clinical trials results and registry database, which was expanded in that public law. The second correction clarifies that the FDA should review and approve generic drug applications separate and apart from citizen petitions pertaining to that application.

I encourage all of my colleagues to join me in support of this bill, and I thank the Members of the Committee on Energy and Commerce for working together to reach agreement on legislation critical to protecting the public health.