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Public Statements

Food and Drug Administration Safety and Innovation Act

Floor Speech

Location: Washington, DC


Mr. BURR. Madam President, let me reiterate what my colleague just said, which is that Chairman Harkin and Ranking Member Enzi have done a wonderful job with a very complicated bill in navigating what was a negotiation that Members of Congress never played a part in--negotiations that happened between the Food and Drug Administration and the pharmaceutical industry for one piece, the device industry for another piece, and the generic drug industry for a third piece; and, I might say, the third piece is the first time Congress will consider this.

I think it is important that Members of the Senate, Members of Congress, and the American people understand that, typically, all legislation is crafted in the Congress of the United States. It is not negotiated in the back room of the Food and Drug Administration or in the back rooms of the device, pharmaceutical, and generic drug manufacturers--except for this. In fact, my amendment gets at the heart of that issue. It is called the amendment ``to ensure transparency in the Food and Drug Administration user fee agreement negotiations.''

The amendment is straightforward. It would ensure transparency in FDA's drug and device user agreement negotiations by allowing Members of Congress or their designated staff to attend the negotiations between the FDA and the industry. What a novel thing to say, that those who are responsible to actually implement the policy could sit in the room and listen. I am not talking about playing a role in negotiating.

Why is this amendment necessary? The bottom line is while the FDA may consult with many of the stakeholders at various points in the process, the drug and device user fee agreements are not negotiated so Members of Congress and the general public know exactly what is in them. Congress is effectively shut out of the process until the negotiated deal behind closed doors is announced. In other words, we are presented with what they have negotiated, and we are basically told: Here is what we want you to pass. At no other point in the legislative process does it happen like this in the Congress of the United States.

The drug and device user fee agreements have significant implications for the American people as well as Congress's ability to do oversight. The No. 1 role of the Congress of the United States is to serve on behalf of the American people as an oversight tool over Federal agencies.

Congress should not have to read between the lines of the minutes of a negotiation to try to figure out, in fact, the spirit of those negotiations. The ability for Congress and the American people to fully understand and weigh the negotiated agreements and the implications they present for patients, taxpayers, the FDA, and for Congress would greatly be improved by ensuring that Congress might attend the negotiations.

Some of my colleagues will probably come down and suggest this amendment would put Congress at the negotiating table and potentially would jeopardize negotiations. It is not true. It is not what I am attempting to do with this amendment. The amendment merely states if a Member of Congress wants to attend or if they want to have their designated to attend in their place, they may. This amendment does not call for Members of Congress to participate in the negotiation, or certainly staff. The negotiations would still be between the FDA and the industry, but it does ensure that Members of Congress or their staff may be in the room and be informed of the negotiations in real time. Congressional staff may be required to comply with all applicable confidentiality agreements. The FDA's negotiations with the industry would not be jeopardized. Let me say that again to my colleagues: would not be jeopardized because the Members of Congress or the staff would be there just for observation purposes.

Let me suggest that if our being in the room jeopardizes the outcome, then we would not be allowed to attend the Supreme Court when some of the most important cases are tried across the street. But Members of Congress and their staff regularly sit in and listen to the arguments that are made.

The fact is, Congress should not have to wait to be informed of how FDA's public health mission could be strengthened and improved on behalf of patients. By having the option to attend the negotiations, Congress and its staff would gain invaluable insight into how Congress can work with the FDA to ensure the agency is fulfilling its public health mission on behalf of patients.

Congress has a critical role to play in the process. When the negotiated user fee agreements arrive on our doorstep, we are expected to take them up, and we are expected to pass them quickly without change. Let me say that again. We are expected to take them up, we are expected to take them up quickly because we do not want to break the continuity of the user fee agreements, and we are expected to do it without change, because to change those agreements would be to break what was negotiated.

Let me suggest to my colleagues: This is the only time in the legislative process where Congress is asked to take somebody else's negotiated product and not to provide the input of two Senators from every State or every Member of the House of Representatives. It completely goes around the structure, the legislative structure, of the Congress of the United States--something that has been tested and tested for hundreds of years.

So Congress is told to tiptoe around the agreements, and we focus our efforts on belt-and-suspender policies to complement the agreements. This does not make for the most deliberative process in considering how Congress can work with the FDA and industry to strengthen and improve FDA's drug and device work.

As a matter of fact, I would say to my colleagues, as we talk about health care policy in this institution, where our goal today is how we reduce the overall cost of health care, remember, as we sign off on this user fee agreement, every dime that is transferred from the industry to an agency means industry is going to have to raise the price of its products to accommodate what they are paying.

What are we here doing? We are raising the cost of pharmaceutical products, devices, and for the first time we are raising the cost of generics because an industry has negotiated something outside of the walls of the Congress of the United States.

FDA faces unprecedented challenges today--challenges we could not have envisioned a generation ago. The agreements and many of the provisions in the Senate bill are intended to help address these real challenges the agency is facing.

But I ask my colleagues this, in closing: What if they do not? What if they do not address the challenges? What if now generic drugs become more expensive than some people can pay because of this agreement? That is why it is absolutely crucial that Congress play a part in this role to balance this policy.

Where will we be in 5 years when it is time to renegotiate this agreement? Well, I hope we are in a much better situation than we are today, that we actually have the right matrix in place through this legislation--not something that was negotiated between the FDA and the industry but something that the Senate of the United States put into this language that gives people on both sides of the aisle the ability to have a yardstick of measurement of success. Did the agency live up to what they promised the industry and, more importantly, does that compute to a beneficial product for patients across this country? I hope that is what we will find 5 years from now. It is what we have tried to construct in a very difficult and challenging piece of legislation.

I will tell my colleagues, this is not an amendment I will ask for a vote on. At the end of the day, the reality is this probably upsets the apple cart a little too much. But I think it is absolutely crucial that somebody ask the questions of how can Congress legitimately stand here and allow something this complex and this important to be negotiated without the input, the full input of the Congress of the United States.

Again, I conclude the same way I started: I think Chairman Harkin and Ranking Member Enzi have done a magnificent job of navigating a very difficult issue, and they deserve a tremendous amount of credit for taking a negotiated product and incorporating what I think are some very positive changes that make this a better product than was negotiated by the private sector and the agency.

My only wish is that the next time we do this, we will not have to try to figure out why certain things happened in the negotiations, we will be privy to those negotiations, and we will better understand collectively how we can take an agency and an industry and public policy and move it in a situation where the American patients are the beneficiaries of it in a much more effective way than I think we have today.

I yield the floor.


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