Unanimous Consent Request

Floor Speech

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Mr. DURBIN. First, let me say to my friend and colleague from Idaho, thank you. The tone of your remarks are positive, constructive, bipartisan. That is exactly what the American people are looking for, at least in Illinois, and I will bet you in Idaho as well.

This national emergency, this public health crisis, should bring out the best in us and not the most political side of our nature. Thank you because I think your remarks were offered in that respect.

We have been here now 3 weeks. This is the third week since returning from a break where most of us were at home. I think this is the longest period of debate on the coronavirus we have witnessed on the floor of the Senate in 3 weeks.

I thought this 3-week period would be all about COVID-19, all about the vaccine. It hasn't. We have taken up many other things that have nothing to do with it. What we have talked about here this morning is encouraging to me. If bringing this resolution up with a unanimous consent request is going to lead to the Senate Foreign Relations and other committees moving forward on important policy questions that you raised, and I hope I raised as well, then it was not time wasted. It was time well spent.

We do agree on so much more than we disagree, I am sure of it, when it comes to this. I invite you, I encourage you, I beg you, as soon as we return from next week's recess, the sooner we can bring a hearing before your committee and others the better.

I would like to address the unanimous consent request of my colleague from Indiana as well.

It has been my good fortune in the House and Senate to work with the Food and Drug Administration. It is probably one of the most underrated agencies of our Federal Government. They make decisions, literally, life-and-death decisions, every single day of things unimaginable to us. It is hard to look at all of the things they regulate and inspect and not be impressed. I have been impressed over the years with the Food and Drug Administration. But the gold standard of the Food and Drug Administration, which was established at least 60 years ago with the Thalidomide scandal, was that this agency was to take a look at drugs that were about to go on the market in America and conduct tests, ask questions, do their own research to determine two things: Are they safe, and are they effective? Safe and effective. That is it. But it is a lot.

Over the years, for 60 years or more, they have used this standard to judge drugs, clinical trials, which carefully measure the impacts of a drug on the human body over a period of time and the like. It is frustrating because, at times, it takes longer than we wish. There are exceptions that have been created at the Food and Drug Administration for extraordinary circumstances wherein it can accelerate the process, but by and large, it has to judge drugs as being safe and effective.

Nearly three-quarters of drugs today are approved in the United States by the Food and Drug Administration before they are approved in any other country around the world. The FDA is considered the gold standard. I have been told that so many times. Many countries look to the Food and Drug Administration in the United States to see if it has approved of a drug's being safe and effective before they move forward. This demonstrates that the Food and Drug Administration has an awesome responsibility but is doing a good job in ensuring Americans have timely access to the same drugs as have patients in other countries.

The ADAPT Act, which Senator Braun brings to the floor, is a solution, I believe, in search of a problem. Sadly, it runs a real risk. This notion that we are somehow going to open up the possibility of a drug's having been approved in another country being approved in the United States quickly, without any review, I think is a dangerous thing to do.

To date, we know what the coronavirus has done to us, and we also know that this bill would completely change how drugs would be approved for sale in the United States of America. It is not a minor bill. It is a major change. Under current law, if a pharmaceutical company wants to sell a drug, it needs the approval of the FDA. It tests it to be sure it is safe and effective. It is the gold standard.

The Senator's proposal would abolish this method. That is significant. Instead, the Senator's proposal says, if a drug has been approved by another developed country--I am not sure of his definition of a ``developed country''--it can bypass standard U.S. regulation and come to market without going through the Food and Drug Administration's study, review, and approval.

It is worth noting that many Members of the House and Senate have criticized the pharmaceutical industry for charging Americans the highest drug prices in the world. I have been in that chorus from time to time and have suggested that drug prices in the United States should be the same as they are in Canada and Europe for the same drugs. Many times, people on the Senator's side of the aisle have resisted that suggestion. They have called it socialism and have said we shouldn't let other countries dictate what America has to pay for drugs. Yet, now, apparently, Senator Braun is comfortable with letting other countries dictate whether our drugs are safe and effective.

This bill is not a targeted response to the coronavirus; it is an open-ended giveaway to some pharmaceutical operation. More importantly, it is putting our safety at risk in America, which we never ever want to do. Instead of approving the resolution I introduced that simply expresses the support for global coordination, Senator Braun wants to completely overturn our Nation's drug approval process.

This bill was introduced more than a year ago. It is still in search of a cosponsor, and it hasn't been consented by the Republican Committee on Health, Education, Labor, and Pensions, which oversees the FDA. Now is the time for the best and the brightest from all nations to work together toward the shared goal of ending this pandemic and finding a safe and effective vaccine. It is not the time to completely upend our Nation's drug approval process to make it easy for some countries to flood our market with unsafe and ineffective drugs.

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Mr. DURBIN. Madam President, I believe there is a unanimous consent request pending. Has there been an objection to my original unanimous consent request?
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