Supplemental Appropriations

Floor Speech

SUPPLEMENTAL APPROPRIATIONS -- (Senate - May 01, 2007)

BREAK IN TRANSCRIPT

Mr. GREGG. Mr. President, I rise to speak today on this FDA bill that has been brought forward by Chairman Kennedy and Senator Enzi. I begin by thanking them for their cooperative, collegial, and inclusive approach over the last couple of weeks to get this bill in a form that makes it much more effective, accomplishing the goals we all have.

Senator Kennedy and Senator Enzi for a long time have been great advocates of making sure we have a strong and effective FDA. Senator Kennedy, of course, has been involved in this for many years and has played a huge role in the success of the FDA, which is, as we know, one of the extraordinarily successful agencies in the Federal Government. It gives the American people confidence, when they go into a grocery store and purchase food or when they go into a pharmacy and purchase a pharmaceutical product or have a prescription filled, that they are going to receive goods which are safe and effective and that they are not going to be at risk of harm as a result of adulteration, fraud, abuse, or misuse of those goods.

It is one of the most amazing successes of our Federal Government in the area of protecting consumers. It arose out of the early 1900 period when there were serious issues relative to food safety in this country, and has evolved into clearly one of the finest agencies, not only in our Government but in the world. It is respected around the world as the gold standard for protecting American citizens and citizens who use the products made by American companies.

This bill builds on that success. I congratulate the Senator from Massachusetts and the Senator from Wyoming for doing such a strong job of building on that success. This bill continues the effort to make sure we have a prompt but safe procedure for getting drugs approved in this country, something called PDUFA, which basically allows drug companies to pay a fairly significant portion of the cost of the approval of new drugs, which has expedited dramatically the rate of approval of new drugs. That means pharmaceuticals and biologics come to the market, which help people, which save lives, which basically makes life better. That is the good news.

In addition, there is, for devices, the MDUFMA proposals, which deal with devices, medical devices the way we deal with pharmaceuticals, setting up a fee system for the approval of medical devices. This is something, when I was chairman of this committee, I had the good fortune to be involved in developing. These two initiatives are the essence of how we maintain a vibrant drug and medical device approval process in this country. It is absolutely critical they be reauthorized, and this bill does it in an effective way.

In addition, the bill takes on a number of other issues which are timely and appropriate. The most significant, from my perspective, although there are a lot of significant ones here, is the issue of drug safety and how we make sure the drugs which do come to the market are safe. This involves not guesswork but finding out what the science is and what happens when people start using these drugs and medical devices. The concept behind that in this bill is that we should set up a regime that basically collects information from all sorts of different sources. There are literally thousands of different sources, but there are some very big ones that we develop information about the reactions people have when they take drugs. We have the tremendous database of the Medicare system, for example. We have the tremendous database of provider groups, such as the Kaiser Permanente fund out in California. These different provider groups have a huge amount of information on what is happening when somebody takes some form of medication. But what happens is that information, although it is collected, is not effectively screened and is not effectively evaluated.

What this bill does, essentially, is create a regime that allows us to more effectively, first, collect the data; second, when there are red flags popping up on that data that say there is a reaction here or reaction there or something occurs here that was not expected, that information becomes more visible under this regime and more available; and then, third, if it is clear there is something that is not going right here, that there is a series of aberrations nobody expected, then it sets up a process where we take that information out and we give it to selected groups of specialists in the academic and private world who have the ability to evaluate that information and tell us what is going on.

There are centers at MIT and I believe at Duke, for example, that do exactly this. The idea, of course, is to first collect the information effectively; second, make sure when those aberrations or red flags start to show up they are noted; and, third, when there is a certain critical mass of information that reflects something that may not be correct or is out of kilter, it makes sure we have that information evaluated in a very science-based, professional way by people who specialize in this and who have the ability to do it--something which FDA does not have the resources, necessarily, to do right now.

With that information in hand, with that science in hand, then you can make decisions. This bill creates a new regime for making those decisions--as to what a company must tell people or tell providers when they are using these different drugs and medications. But it will be a science-based decision, and that is the key here. All of this will key off of science that is hard and that is effectively reviewed and evaluated in order to come to the conclusion that certain actions must be taken in how you distribute this medication and how you communicate what the implications of this medication are. So this new safety and surveillance regime, which is known as mining the information, and then pulling it together and taking advantage of it, validating it and integrating it--this new regime is at the essence of the safety concerns which are involved in this bill.

It is very positive. It opens a new world of review in the area of pharmaceuticals and medicines, a postmarket review process which will be based on science and which will be very healthy to the system as a whole. I congratulate and thank both Senator Kennedy and Senator Enzi for evolving this process in this bill.

In addition, there is the pediatric language in this bill. There is the BSE program, which is the program which basically rewards companies that are willing to go out and do extra research to see how a drug might affect a child. Historically, drugs will be brought to the market and you would never know--because all the clinical exams have been done on adults--how they would affect children. Some of these drugs, obviously, if given to a child, could have a significant negative impact and, if given in the wrong doses, might have an extraordinarily adverse effect. Some could actually be very positive if given in the right dosage. So it became a guessing game as to when these pharmaceuticals, when these medications, were good for children, in many instances. As a result, doctors and prescribers simply didn't know whether to make them available, in many instances, to children.

This BSE pharmaceutical procedure said essentially, We will give you, the producer of this pharmaceutical, of this medication--we will give you an extra 6 months of exclusivity in exchange for your testing this and making sure it will work effectively, or finding out if it will not work effectively, on children. The practical effect of that, of giving that incentive, has been that hundreds of new drugs have been made available to children which were not available before. This has had a very positive impact on children and the ability of children to get pharmaceuticals.

With the BSE program, we also developed a program called the Pediatric Research Equity Act, which essentially takes the opposite approach from the BSE program. It creates a mandate where, in certain instances, certain medications have to be tested on children. They have to go through a process of seeing if they will work for children. The two together basically work in tandem and the idea is they will feed off of each other, and you will create an atmosphere out there where the two different approaches--one basically being a carrot and the other being a stick--will lead to better medications being available for children.

It has worked amazingly well. The key to this, of course, is to keep these two in tandem. In order to accomplish that, they both, in my opinion--and fortunately in the opinion of the chairman and the ranking member of the committee now, at least--have to be on the same wavelength. They have to be dealt with the same way relative to things such as their sunsets, when they get reviewed and when they don't get reviewed, because if you were to have one sunsetted at a different time than the other or one sunset and the other not sunset, you wouldn't get an effective review of the two together, and they both work, as I said, together.

This bill makes sure they are treated the same way in that area, and that is a major step in the right direction toward making sure children get proper pediatric care. There is still going to be an issue tomorrow, I understand, on exclusivity, which is going to be brought up by another Senator; that is, the length of the exclusivity that is necessary in order to get pharmaceutical companies to pursue proper research on children is an issue. But I happen to think what we have now has been shown to work, and why fix something that is not broken, in my opinion. So I believe we should stay with what we have for the 6-month exclusivity period.

In addition, there are a number of other issues floating around this bill. This bill, obviously being a major health care bill, attracts a lot of other concerns. One of them that I have filed as an amendment--but I don't intend to bring it up unless we move into the issue of reimportation, which may be brought up on the floor--is the question of safety of Internet pharmacies. I believe very strongly, when somebody goes on line and purchases a pharmaceutical product over the Internet--which is happening more and more often as people become more comfortable with dealing with the Internet on a variety of different levels, but certainly senior citizens as people age into their senior citizenship years who had been dealing with the Internet for quite a few years and are comfortable with it--I believe it is critical we have in place a system which allows people, when they look at the site on the Internet, to know whether that Internet pharmacy is selling the product they say they are selling and whether the product they say they are selling has received FDA approval.

The problem we have here is a lot of these pharmacies will represent that they are selling some sort of pharmaceutical good and it turns out that product is, in many cases, adulterated or inappropriately made, in which case people end up getting a pharmaceutical product which is bad for them. In some cases it can actually lead to death. So it is critical that we have a way so when somebody goes on the Internet and looks at a site on the Internet, they know that Internet pharmacy they are looking at is legitimate and the products they sell are legitimate and have been through the FDA approval process.

In order to accomplish that, we need to set up a whole new regime, basically, and we need to pay for it. This amendment which I have put in accomplishes that. It essentially gives the FDA the authority to review pharmacy sites on line, to meet with the people who have set up those sites, to make sure to set up a certification process where they are guaranteed the sites are meeting the conditions of selling pharmaceutical products or medications which have met the FDA approval, and then to put sort of a Good Housekeeping seal on that site, which is tamperproof, which says this site has FDA-approved products. It would be a huge step forward in safety for American citizens using Internet pharmacies.

It is complicated, though, in its enforcement. It is simple to state but complicated to enforce because it means the FDA needs the resources to deal with these sites and also to deal directly with these pharmaceutical Internet sales places which may be somewhere other than the United States. Second, you have to have in the United States a point at which you can deal with the site if something goes wrong, a responsible representative on the ground in the United States who has the economic wherewithal to basically bond the site, for all intents and purposes.

Setting up that type of regime will be expensive. The language of this amendment puts in place a fee system which allows that to be paid for so we can be assured that the FDA has the resources necessary to review these sites and accomplish this goal of making sure these Internet pharmacy sites are safe for Americans to use. I think this would be a tremendous step forward in safety for all Americans, especially as we move toward a much more Internet-oriented purchasing process in this country.

Another issue which is going to be discussed here, and which I understand from the chairman may be held over for conference or come into play in some area, is a crucial issue of follow-on biologics or similar biologics.

We know we can produce a generic pharmaceutical and do it with a fair amount of predictability. We know that if a generic company brings on a pharmaceutical product which has run its course, it has proper patent coverage, that that generic is going to be safe and effective and be essentially the same thing as the pharmaceutical because they are chemical compounds.

In the biologics area, this is not the case because you are dealing with a much more complex process of producing the biological medication. It is a fermentation process, it involves proteins, it involves mutation of proteins, which depends to a great extent on a huge number of factors which are very uniquely identified with the way that that vat of medication was evolved through the process.

Anyone who has been to one of these facilities can see how complex it is to maintain consistency, even within the facility that is producing the medication. If you stepped out of that facility and tried to reproduce that medication, the complexities would even be more difficult to replicate.

It is critical that as we move into this biologic area, we understand we are not dealing with generic pharmaceuticals. You know, when you put the title ``generic pharmaceuticals'' on something that is sort of a motherhood term, that is a good idea. It is a good idea if it works. But if you put the generic title on biologics, you are probably going to mislead a lot of people and, in the process, potentially produce medicines which can be extremely harmful or could not accomplish the purposes.

So as we move down this road of looking at biologics and how we give the opportunity to produce similar biologics to people after the patent life has run, we have to be very careful that we don't oversimplify the exercise in the name of getting something, as ``motherhoodish'' as generics; rather, we have to make sure we put in place a process which allows those biologics, when they are produced as similar biologics, to have been properly reviewed to be sure they accomplish what they claim they are going to accomplish.

This means that almost in every instance of an individual biologic, you are going to have to have clinical trials for the similar biologic. There are going to be very rare instances where you can actually bring to the market something that doesn't go through clinical trials in this area, in my opinion, and you have to be very sure that you demonstrate safety and effectiveness of the similar product before you step into this arena of awarding the authority to go ahead and sell that product in the market generally.

You will also need very aggressive postmarket surveillance in this area because you do not know, in many instances--you hope you know, but you do not necessarily know--how individuals will react to taking this type of medication, which is developed as a similar medication, as versus the basic medication which is trying to be replicated.

This area of biologics is a complex one. It should not be rushed into. I know there is a great desire to step forward and say: We have a huge victory for the American people, we can now have generic biologics. But if we rush into this exercise and create a process with approval which does not adequately account for the significantly, the exponentially more complex process of bringing online a biologic when compared to a chemical pharmaceutical, then we will not have done our job as policy people but will simply have given ourselves a good press release and in the end probably have given ourselves a very dangerous process relevant to protecting the American people in the area of biologics.

As we move down this road of generics, I do hope we will move in a way that understands there is a significant difference in pharmaceuticals and that those differences are going to require a much more detailed and a much more complex approval process than we presently have in moving in the generic pharmaceutical area.

Those are some of the concerns I have relative to other issues that might be brought up in this bill. But I do again wish to congratulate the Senator from Wyoming, I wish to congratulate the chairman from Massachusetts for once again bringing to the floor a very strong piece of legislation, which will significantly improve the capacity of the FDA to continue its extraordinary record of protecting the American people relevant to food and drug safety.

I yield the floor.

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