Food and Drug Administration Safety and Innovation Act--Motion to Proceed--Continued

Floor Speech

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Mr. REED. Mr. President, I rise today in support of the Food and Drug Administration Safety and Innovation Act, which is pending before the Senate this week.

This legislation will give the FDA, through five agreements made between the agency and industry, the resources to approve additional drugs and devices every year for their safe and effective use. Without these agreements, the FDA, starting in October, would lack these resources which are necessary to approve new drugs and devices, and they would also lack resources to monitor the safety and efficacy of those drugs already on the market. This would result in a reversal of decades of work modernizing our drug and device approval and safety programs.

I am particularly pleased that for the first time, the generic pharmaceutical industry will provide the agency with $1.5 billion over 5 years for faster product reviews. In fact, the essence of the legislation is that the industry is actually providing resources for the monitoring and for the approval of drugs. Getting generic drugs onto the market sooner will help lower costs for individuals and families as well as for the Federal and State governments.

This measure would also significantly improve FDA's regulatory authority, including its ability to help prevent drug shortages and to partner with the private sector to develop new medications to treat life-threatening diseases that have become resistant to antibiotics, which is a very important measure included within this legislation.

I wish to recognize especially Chairman Harkin and Senator Enzi for their very thoughtful, very deliberative, and extremely important work. They have represented through their committee work the model of what we should be doing here collaboratively and on a bipartisan basis to advance important measures for the American people. Both of them deserve great accolades for their work today. I hope we can follow through and bring their work to conclusion.

I wish to particularly thank both of them, Chairman Harkin and Senator Enzi, for including provisions pertaining to pediatric drugs and devices that I authored along with my colleagues Senator Alexander, Senator Murray, and Senator Roberts, another bipartisan effort to improve the health of children throughout this country.

Until 1997--15 years ago--80 percent of drugs were used off-label to treat children. Doctors were treating children without fully understanding the appropriate dosage requirements or the potential for any dangerous side effects. This frustrated pediatricians and angered many families, but those sentiments were largely ignored by the industry until Congress stepped in.

With the passage of the Best Pharmaceuticals for Children Act in 1997 and the Pediatric Research Equity Act in 2003, 427 drugs have been relabeled with important pediatric information. Now 46 percent, rather than 80 percent, of drugs are being used off-label in children, but that number is still too high. The legislation before the Senate makes critical improvements to these laws so we can further lower this percentage. It would make these two acts--BPCA and PREA--permanent, like the laws that govern the approval of drugs for adults. It would also provide the certainty that the pharmaceutical companies believe is necessary to continue to wisely invest in the appropriate use of drugs in children.

The legislation will also help ensure pediatric studies are planned earlier in the drug development process and completed sooner. Currently, a disappointing 78 percent of studies that were scheduled to be completed by September 2007 are either late or were submitted late. While Congress, the FDA, advocates, and the industry agree that a pediatric study should not hold up the approval for a drug for use in adults, drug companies should not be allowed to get away with submitting unrealistic study plans to the FDA for approval or failing to complete a required study once they are profiting from these drugs on the market.

The legislation that is before us would also require pharmaceutical companies to work with the FDA early in the process of developing these drugs to create a reasonable and sensible plan for studying the products in children. It would also, for the first time, provide FDA with an enforcement tool that will deter companies from neglecting their obligation to complete these studies on time.

Our bill also responds to the need for pediatric medical devices--not just pharmaceuticals, but devices--in children, which can lag 5 to 10 years behind those manufactured for adults. The pediatric profit allowance for Humanitarian Use Devices has proven to be a very effective incentive. Three new devices have been approved for their use in children in the last 3 years. This is an incredible increase as a result of this incentive.

This policy has shown much promise and I am pleased to see it continue in this bill, along with the Pediatric Device Consortia Grant Program, which has assisted the development of 135 proposed pediatric medical devices in just over 2 years.

The Food and Drug Administration Safety and Innovation Act would also extend this Humanitarian Use Device incentive to manufacturers of devices for use in adults with rare conditions. While it is my hope this policy is equally effective in spurring developmental devices for use in adults as it is for children, I am concerned that it could impact the development and the marketing of devices for use in children. I plan to monitor this policy closely should it become law, but I have full expectations that both noble objectives can be achieved.

There are some children, however, who do not receive the full benefits of BPCA and PREA.

I am pleased the Senate bill begins to address this problem for pediatric cancer patients and children with other rare diseases. It calls on the FDA to hold a public meeting to discuss ways to encourage the development of new treatments for this population. Indeed, for some pediatric cancers, the treatment has not changed in many decades. For other rare diseases, an effective treatment has yet to be found. I look forward to receiving a recommendation that might stem from this important meeting, as well as working with my colleagues to respond to their needs with reasonable and sensible policy.

I am truly pleased these pediatric provisions have drawn the support of 24 organizations, including the American Academy of Pediatrics, also including the Pharmaceutical Researchers and Manufacturers of America. I think this stakeholder support is very important not only to the ultimate passage of the legislation, but for its effective implementation.

There is another provision I would like to talk about; that is, this bill contains provisions which would require the FDA to decide whether to update the labeling requirements for tanning beds.

Every day 2 million Americans visit a tanning salon. Seventy percent of these are women. According to the World Health Organization, the risk of deadly melanoma increases by 75 percent when the use of tanning devices begins before the age of 30.

So this is a particular concern with young women beginning to use--and younger men--beginning to use these tanning devices. Yet the warning labels on tanning beds have not been updated in over three decades and are often placed far from view.

In 2007 my colleague, Senator Isakson of Georgia, joined me in requiring the FDA to study the labeling standards for tanning beds and make recommendations about how these standards could be improved. In its report, the FDA found that tanning bed labels could be clarified and located in a more prominent location. But the agency has yet to act. It is my hope the FDA will heed its own advice and update the labeling requirements for tanning beds.

Similar to the outdated labeling requirements for tanning beds, sunscreen testing and labeling standards have also been over three decades in the making--three decades. Last year I was pleased when the FDA finally took action. However, just last week the agency announced it would be extending the implementation of these new standards by 6 months, until December. Consumers will have to go another summer without knowing whether they are truly protected from the Sun's harmful UVA and UVB rays.

I have filed an amendment to make sure there are no future delays. I look forward to working with my colleagues to see that this amendment is accepted as part of the final FDA legislation which I hope is passed very quickly by the Senate.

I again want to thank Chairman Harkin and Senator Enzi for their extraordinarily effective and collaborative work on the Better Pharmaceuticals and Devices for Children Act, which is included in this bill.

STUDENT LOAN INTEREST RATES

Mr. REED. Just for a moment, let me raise another pending issue which is of critical importance. In 40 days, as I think many of us recognize, student borrowing rates for college will double unless we act. We have seen both sides of the aisle--colleagues from both sides--come down and say we cannot let this happen. Well, we cannot let it happen. That means we have to take action to prevent the doubling of interest rates on Stafford loans.

Unfortunately, last week we had a series of budget votes, which most of my Republican colleagues supported, which would have, if they had passed, mandated the doubling of the student loan interest rate. So I think we have to move away from this debate and actually pass legislation which would prevent the doubling of student loans by July 1. I hope we can do it promptly, certainly before July 1.

Also, I hope we find an effective offset. What the Republicans have suggested is using the Prevention Fund. The President made it clear he would veto the legislation if it included that offset. Also, what should be clear that using resources to prevent disease is not only helpful to the American public, but it is also probably one of the most practical ways we are going to be able to begin to bend that very important cost curve going forward.

This Prevention Fund is going to help everyone, but it is going to particularly help middle-income families who are struggling with medical bills, who are struggling to find insurance, the same families who are struggling to pay the cost of college for their children. It makes no sense to me to take from one program that will largely benefit working families to pay for another program that will benefit working families.

We have an offset which is an egregious tax loophole that allows lobbyists, financiers, et cetera, to create subchapter S corporations to essentially avoid their payroll and Medicare taxes. I think that is an appropriate way to pay for this support for students' education. If there are other ways beyond the prevention fund, I certainly am happy to listen to them. If there are other principled ways to avoid doubling the interest rate for student loans, let's talk about them. Let's get them on the Senate floor and let's debate them.

I yield the floor

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