Medical Devices Technical Corrections Act

Mr. Speaker, as the Chairman of the appropriations committee that funds the Food and Drug Administration, I feel that I must register my concerns.

We have seen user fees for human drugs, animal drugs, and now medical devices. That is fine--companies are paying for a service, and they have been able to invest in FDA to gain efficiency.

Mr concern arises over requirements in the user fee legislation for certain levels of appropriations for those programs--usually referred to as ``triggers''. Medical devices is the most extreme example. The authorizing legislation requires tremendous increases in appropriated funding.

I would like to submit for the Record a letter that Chairman Young and I sent to Chairman Tauzin last October outlining these concerns.

October 21, 2003.

Hon. W.J. (Billy) Tauzin,

Chairman, Committee on Energy and Commerce, House of

Representatives, Rayburn House Office Building,

Washington, DC.

Dear Chairman Tauzin: We are writing to you as our partners

in maintaining the viability of the Food and Drug

Administration (FDA). We have a very collegial and positive

working relationship with your Committee in its role as

authorizers for FDA activities, and we appreciate your

diligence in providing critical oversight. However, we write

to you today with concerns we have as appropriators with the

responsibility for setting annual appropriations levels for

the FDA.

We see a trend occurring within the authorizing legislation

for user fee programs. Prescription drug user fees were first

authorized in 1992. That legislation included a ``trigger''

which required that appropriations for FDA as a whole and for

drug review, in particular, meet certain levels in each of

the years that the user fees were in effect. The two

reauthorizations of those user fees retained the

appropriations requirements; in fact, in the last

reauthorization in 2002, additional triggers were added. Also

in 2002, medical devices user fees were enacted. Again,

requirements for FDA appropriations were integral to the user

fee legislation. In the case of the medical device

legislation, the requirement for appropriated funding of the

medical device program included substantial and sustained

increases in budget authority. The authorization language

stipulates that if the cumulative appropriations trigger is

not met, the user fee program will cease at the end of fiscal

year 2005. This requirement was included without consultation

with the Committee on Appropriations.

Most recently, the House and Senate have passed similar

legislation allowing for the collection of animal drug user

fees. Again, both the House and Senate versions of the bill

contain requirements for certain levels of FDA

appropriations. According to some published reports, your

Committee had received assurance from the leadership that

funding levels for animal drug reviews would be increased in

fiscal year 2004. Again, the Committee on Appropriations was

not consulted in these negotiations.

In effect, these triggers in user fee legislation earmark

FDA funds for human drugs, medical devices, and animal drugs.

The Committee on Appropriations has always supported FDA as a

whole and has resisted efforts to add budget authority to one

program area at the expense of another. If we let user fee

triggers drive our decisions, the FDA programs to suffer

would be those not covered by fees--blood, vaccines, counter-

terrorism activities, food safety, or bovine spongiform

encephalopathy (BSE) prevention. We firmly believe that a

strong FDA must balance the needs of all its mission areas to

best benefit public health. We have serious concerns about

the prevalence and scope of appropriations requirements

embedded in user fee authorizing legislation for FDA, and

about the lack of consultation with our Committee in

legislating such requirements.

A larger problem is the fact that your Committee's

jurisdiction over the Agriculture Appropriations Bill is

limited to the FDA. It is our Committee's task to establish

fair allocations of resources among competing interests under

the jurisdiction of all authorizing committees. Legislating

triggers for individual programs serves to thwart our efforts

at fairness by favoring a limited number of programs at the

expense of others in our bill--including the Special

Supplemental Nutrition Program for Women, Infants, and

Children (WIC), agriculture research, and conservation

activities. These programs are critically important to many

members and their constituents.

As always, we are available to discuss the issue with you,

and would be glad to do so. We share your dedication to

improve the effectiveness and viability of FDA's programs

that are crucial to our nation's well being.

Sincerely,

C.W. Bill Young,

Chairman, Committee on Appropriations.

Henry Bonilla,

Chairman, Subcommittee on Agriculture, Rural Development,

FDA and Related Agencies.

Mr. Speaker, earlier this month I was not present for several recorded votes because pressing business required me to remain in Colorado. If I had been present, I would have voted as follows:

Rollcall No. 42--H. Res. 519--Expressing the sense of the House of Representatives with respect to the earthquake that occurred in San Luis Obispo County, California, on December 22, 2003, I would have voted ``yes.''

Rollcall No. 43--H. Res. 392--Congratulating the Detroit Shock for winning the 2003 Women's National Basketball Association championship, I would have voted ``yes.''

Rollcall No. 44--H. Res. 475--Congratulating the San Jose Earthquake for winning the 2003 Major League Soccer Cup, I would have voted ``yes.''

Rollcall No. 45--On approving the Journal, I would have voted ``no.''

Rollcall No. 46--S. 1881: to amend the Federal Food, Drug, and Cosmetic Act to make technical corrections relating to the amendments by the Medical Device User Fee and Modernization Act of 2002, and for other purposes, I would have voted ``yes.''

Rollcall No. 47--H. Con. Res. 373: expressing the sense of Congress that Kids Love a Mystery is a program that promotes literacy and should be encouraged, I would have voted ``yes.''

Rollcall No. 48--Amendment to H.R. 339 offered by Mr. Scott (VA) to add a new section which provides that the bill does not apply to an action brought by a State agency to enforce a State consumer protection law concerning mislabeling or other unfair and deceptive trade practices, I would have voted ``yes.''

Rollcall No. 49--Amendment to H.R. 339 offered by Mr. Watt to limit the provisions of the bill only to cases brought in Federal court, I would have voted ``yes.''

Rollcall No. 50--Amendment to H.R. 339 offered by Mr. Andrews to permit civil liability suits to be brought in cases related to a food that contains a genetically engineered material unless the labeling for such food bears a statement providing that the food contains such material and the labeling indicates which of the ingredients of the food are or contain such material, I would have voted ``no.''

Rollcall No. 51--Amendment to H.R. 339 offered by Mr. Ackerman to expand the definitions in the act to exclude any establishment that manufactures or sells meat from downed animals for human consumption from the protections of the bill, I would have voted ``no.''

Rollcall No. 52--Amendment to H.R. 339 offered by Ms. Jackson-Lee (TX) to provide that the bill would not apply to civil actions that allege a product claiming to assist in weight loss caused heart disease, heart damage, primary pulmonary hypertension, neuropsychological damage, or any other complication which may be generally associated with a person's weight gain or obesity, I would have voted ``yes.''

Rollcall No. 53--Amendment to H.R. 339 offered by Mr. Watt to strike section 3(b) of the bill which provides that a qualified civil liability action that is pending on the date of the enactment of the bill shall be dismissed immediately by the court in which the action was brought or is currently pending, I would have voted ``yes.''

Rollcall No. 54--Final passage of H.R. 339, to prevent legislative and regulatory functions from being usurped by civil liability actions brought or continued against food manufacturers, marketers, distributors, advertisers, sellers, and trade associations for claims of injury relating to a person's weight gain, obesity, or any health condition associated with weight gain or obesity, I would have voted ``no.''

Rollcall No. 55--Final passage of H.R. 3717, to increase the penalties for violations by television and radio broadcasters of the prohibitions against transmissions of obscene, indecent, and profane material, and for other purposes, I would have voted ``yes.''

Rollcall No. 56--Motion to Suspend the Rules and Agree to H. Con. Res. 15, Commending India on its celebration of Republic Day, I would have voted ``yes.''

Rollcall No. 57--Motion to Suspend the Rules and Agree to H. Res. 540, as amended, expressing the condolences and deepest sympathies of the House of Representatives for the untimely death of Macedonian President Boris Trajkovski, I would have voted ``yes.''

Mr. President, it is after Labor Day so the campaign rhetoric is in full bloom. One thing we have already heard and continue to hear is this charge of a ``do-nothing'' Congress. And in yet another great paradox unique to this town, we find those who complain that the Senate is not driving ahead and are themselves the roadblock to progress.

For a year and a half we have seen a stall ballgame for the ages, an effort to run out the clock on this session practically before it began. We have seen unprecedented obstruction by a determined minority. Sadly, tactics not employed since the founding of the Republic have become commonplace in this body. We have seen tactics employed not only against highly controversial items but against noncontroversial, broadly supported items, too.

The CARE Act, which provides numerous tax improvements to assist and empower those who run, contribute, and benefit from our charitable organizations passed the Senate 95 to 5. No Democratic Senator voted no. Yet our colleagues on the other side of the aisle refuse to let this bill go to conference and, therefore, it lies near death.

Fortunately, I understand that the IDEA bill, which reforms and enhances the funding of education for disabled children--which passed the Senate 95 to 3--may well be going to conference tonight. If so, that is excellent movement in the right direction.

The Workforce Investment Act, which authorizes the worker training programs for young people, dislocated adults, veterans, Native Americans, seasonal workers, and migrant workers, passed the Senate last year by unanimous consent. No one objected. Yet this bill also has not been able to go forward. Think about it. Bills virtually with no voiced opposition are being stopped by a silent and shadowy force, and the American people are being denied better jobs, better education, and a more compassionate society all because of a pattern of obstruction.

I think the practitioners of this obstruction owe an explanation to the American people as to why they are blocking these widely supported bills that they previously voted for on the Senate floor.

Fortunately, the majority leader's extraordinary effort and patience has enabled much to be done in spite of the obstruction. We have passed tax cuts to get the economy going again, and it sure is going again. We have passed a Medicare prescription drug benefit that is giving seniors an immediate helping hand with a full comprehensive benefit to start in about 15 months. We have passed a Do-Not-Call Registry and the Healthy Forest Act, the partial-birth abortion bill, and the NATO enlargement treaty. But that was last year. What about this year?

We passed into law a pension relief and stabilization plan for private sector businesses, workers, and their retirees. We passed into law a BioShield Act to improve countermeasures from biological, chemical, and other terrorist attacks. We passed into law the Unborn Victims of Violence Act and also a Defense appropriations bill, as well as a supplemental for operations in Iraq.

So much has been accomplished, but much more can and should be done. I call on our colleagues to allow us to move forward on the Workforce Investment Act and CARE right now so we can have an America with workers trained for the modern workplace, a better educational environment for our children, and a more compassionate safety net for our citizens.

I yield the floor.

Mr. President, let me say briefly to my good friend from Nevada, I remain hopeful, as I know he does, that we will indeed be able to pass the FSC bill before we leave this year. I am optimistic that will be the case.

Mr. President, this week the Senate completed action on S. Con. Res. 95, the fiscal year 2005 budget resolution, under the tremendous leadership of Chairman Nickles. As we look over the last 4 days, we have had a very busy course with debating and disposing of 64 amendments to the budget resolution. There were 25 rollcall votes in relation to the amendments, including passage.

We had a long day of voting yesterday until the early hours of this morning with 19 votes, and Senator Nickles guided the budget resolution to passage early this morning by a vote of 51 to 45.

In addition to that business, we were able to clear executive nominations. The Senate confirmed 17 nominations. Two of the nominations confirmed were district judges from Arizona and Mississippi. I am pleased we were able to clear these judicial nominations, and I look forward to continuing this process for the remaining nominations that are on the calendar.

Indeed, there are approximately 22 judges on the calendar, of which I believe 15 or so should move expeditiously. I will continue to work with the Democratic leader in scheduling these when we return from the recess. I understand the Democratic leader mentioned additional nominations, and I will be consulting with him on those as well. He mentioned them earlier today and last night, and we will be consulting on those nominations.

Late last night, as I mentioned earlier, the Senate confirmed the nomination of Mark McClellan to be Administrator of the Centers for Medicare and Medicaid Services.

Yesterday, the Senate also spoke with one voice with regard to a tragedy, the deadly attack yesterday against the people of Spain. Our condolences were expressed. We had a moment of silence yesterday to honor the people of Spain. In addition, we sponsored a resolution that condemned this

cowardly act. Our prayers continue to go out to the leaders and the people of Spain over what we know is a very difficult time.

In addition, we consider other matters that people do not see very much, and I won't go through all of them, but we passed S. 741, the animal drug bill that Senator Sessions sponsored that provides for new drugs on what are called minor animals.

We passed H.R. 3195 just this morning, a bill that extends Small Business Administration programs. That is Senator Snowe's bill.

We passed H.R. 254, which are amendments to the U.S.-Mexico Agreement on the Border Environment Cooperation Commission and the North American Development Bank. Senator Hutchison was instrumental in clearing this bill.

The list goes on. I did want to reflect the amount of work we were able to pull through over the course of the week.

In addition, we were able to ratify the United States-Japan Tax Treaty reported by Chairman Lugar and the Foreign Relations Committee. This is a very important treaty.

We just passed Senator Alexander's S. 1881, the Medical Devices and Technical Correction Act.

Senator Specter secured passage of S. 2043, which designates a Federal building in Harrisburg, PA, as the ``Ronald Reagan Federal Building.''

Senator Shelby assisted in passage of H.R. 3724.

So we had a very productive week by anyone's measure. I wanted to notice the hard work and efforts of all of my colleagues with respect to these legislative and executive accomplishments.

Mr. Speaker, I move to suspend the rules and pass the Senate bill (S. 1881) to amend the Federal Food, Drug, and Cosmetic Act to make technical corrections relating to the amendments made by the Medical Device User Fee and Modernization Act of 2002, and for other purposes, as amended.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks and include extraneous material on S. 1881.

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

Mr. Speaker, I rise today in support of S. 1881, the Medical Devices Technical Corrections Act. S. 1881 is the companion to H.R. 3493, a bill I introduced with the gentlewoman from California (Ms. Eshoo), which makes technical and clarifying amendments to the Medical Device User Fee and Modernization Act of 2002. That bill was signed into law by President Bush on October 26, 2002, and made sweeping changes to the laws that govern device approvals to establish new programs and streamline processes to accelerate the availability of medical devices to patients.

H.R. 3493 passed the House on January 27 by a vote of 333 to zero and S. 1881 had passed by unanimous consent in the Senate on November 25, 2003. S. 1881 amends the Medical Device User Fee and Modernization Act to ensure that it is being implemented properly.

These two bills differ slightly, and the amended bill we are considering today is the conferenced version of this legislation. Staff have resolved the fairly minor differences between the Senate and House versions of the legislation, and this legislation should ultimately become law.

Some of the changes are truly technical, while others clarify the intentions of Congress in the Medical Device User Fee Act. For example, this legislation ensures that the user fee reductions that apply to small businesses apply for 2004 and years in the future. In addition, S. 1881, as amended, clarifies that as part of the third-party inspection program, companies must submit reports of inspectional findings consistent with current FDA practices. And S. 1881 clarifies which data need to be submitted for a firm to be eligible for third- party consideration.

Medical devices are some of our health care system's most remarkable innovations. The provisions in this technical and clarifying amendments bill will allow the FDA to continue to reduce review times, increase the efficiency of its operations, and allow these wonderful technologies to be delivered to patients more quickly.

I want to thank the gentleman from Texas (Chairman Barton), the gentleman from Florida (Mr. Bilirakis), and the ranking members, the gentleman from Michigan (Mr. Dingell) and the gentleman from Ohio (Mr. Brown), as well as the gentleman from California (Mr. Waxman) and each of their staff for this legislation. This has been another outstanding example of teamwork and bipartisanship on the Committee on Energy and Commerce. I urge Members to support this legislation.

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

Mr. Speaker, I have no further requests for time, and I yield back the balance of my time.

Mr. Speaker, on that I demand the yeas and nays.