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Public Statements

Statements On Introduced Bills And Joint Resolutions

Location: Washington, DC



Mr. KENNEDY. Mr. President, it is a privilege to join Senator Enzi in introducing the Enhancing Drug Safety and Innovation Act of 2007. The goals of the legislation are to strengthen the Food and Drug Administration's authority over the safety of prescription drugs after they are approved; to encourage innovation in medical products; to increase access to clinical trials for patients and ensure that doctors and patients are aware of the results of clinical trials involving the drugs they prescribe and use; and to improve the screening of members of FDA's scientific advisory committees to avoid conflicts of interest.

The withdrawal of the drug Vioxx from the market 2 years ago demonstrated again that all prescription drugs have risks, many of which are unknown when a drug is approved, or even for years after approval. We need a more effective system to identify and assess the serious risks of drugs, inform health care providers and patients about such risks, and manage and mitigate these risks as soon as they are detected.

Our bill will require drugs to have a risk evaluation and mitigation strategy when it is approved. For many drugs, the strategy will include only the drug labeling, reports of adverse events, a justification for why only such reporting is needed, and a timetable for assessing how the REMS is working.

The FDA will be able to include additional requirements for drugs that pose serious risks, such as by requiring that the drug be dispensed with labels that patients can understand, that the drug company have a plan to inform health care providers about how to use the drug safely, and that a drug should not be advertised directly to consumers for up to 2 years after approval. If a serious safety concern needs to be understood, FDA can require further studies or even clinical trials after the drug is approved. Enhanced data collection and data mining techniques will help identify risk signals earlier and more thoroughly.

For drugs with the most serious side effects, FDA will be able to require that its risk evaluation and mitigation strategy include the restrictions on distribution or use needed to assure its safe use.

The FDA will be able to impose any of these requirements at the time a drug is approved. The agency can also modify the labeling or otherwise alter a drug's availability after the approval. The drug's manufacturer will propose the overall strategy, or modifications to it, and the FDA and the company will try to work out an adequate compromise. If the agency and the company cannot agree, the agency's Drug Safety Oversight Board can review the dispute and recommend a resolution to senior FDA officials, who will make the final decision.

Civil monetary penalties are added to FDA's traditional enforcement authority to ensure compliance. Drug user fees will also be used to review and implement the program.

The bill formalizes and makes mandatory what is now only informal and voluntary. Our intent is not to change the standards for approving drugs, but to see that the FDA has the ability to identify, assess, and manage risks as they become known. Better risk management will mean that drugs with special benefits for some patients will remain available, despite serious risks for other patients, because FDA can better identify the risks and manage them.

The bill helps to improve drug safety in other ways as well. The Reagan-Udall Institute for Applied Biomedical Research will be a new public-private partnership at the FDA to advance the agency's critical path initiative. The initiative is intended to improve the science of developing, manufacturing, and evaluating the safety and effectiveness of drugs, biologics, medical devices, and diagnostics.

The Institute will be supported by Federal funds and by contributions from the pharmaceutical and device industries. Philanthropic organizations will be able to supplement Federal support. The institute will have a board of directors and an executive director, and will report to Congress annually on its operations.

The bill will also expand the public database at NIH to encourage more patients to enroll in clinical trials of drugs. The database will build on the current systems and would include late phase II, phase III, and all phase IV clinical trials for all drugs.

A second, publicly available database would include the results of phase III and phase IV clinical trials of drugs, with the possibility that late phase II trials would be added later. Posting of results could be delayed for up to 2 years, pending the approval of the drug or the publication of trial results in a peer- reviewed journal.

The public needs to know about the results of clinical trials on drugs. Tragically, such information was not adequately available for the clinical studies of antidepressants in children.

Posting information in the clinical trials registry and the clinical trials results database will be requirements for federal research funding and for drug review and approval by the FDA. Both the FDA and other appropriate offices in the Department of Health and Human Services will review the content of submissions to the results database to ensure they are truthful and nonpromotional. These Federal requirements will preempt State requirements for clinical trial databases.

Finally, the bill will improve FDA's process for screening advisory committee members for financial conflicts of interest. The agency relies on advisory committees to provide independent, expert, nonbinding recommendations on significant issues. Ideally, committee members should be free of any financial ties to the companies affected by an issue before a committee. But at times, there may be no individual without financial ties to such companies--for example, when the issue involves a rare disease or a cutting edge medical technology. In these cases, the FDA must be able to grant a waiver to allow an individual with essential expertise to serve on the committee. The bill will require the agency to seek qualified experts with minimal conflicts, clarify how it makes waiver decisions, and disclose those decisions at least 15 days before a committee meeting.

Our bill is a comprehensive response to drug safety and other important issues involving prescription drugs and other medical technologies. I commend Chairman Enzi and his dedicated staff--especially Amy Muhlberg--for working closely with us on this proposal, and I urge our colleagues to support it.



S. 486. A bill to establish requirements for lenders and institutions of higher education in order to protect students and other borrowers receiving educational loans; to the Committee on Health, Education, Labor, and Pensions.

Mr. KENNEDY. Mr. President, it's a privilege to join my colleague, Senator DURBIN, in introducing the Student Loan Sunshine Act, to provide greater support for students and families across America who are struggling with great difficulty to pay for college.

Over the past 20 years, the cost of attending college has doubled. Today, the average cost of attendance at a 4-year public college is almost $13,000. As a result, students and families are going deeper and deeper into debt to finance the cost of higher education. In 1993, fewer than a third of students at four-year colleges graduated with debt to pay on their student loans. Today that number has doubled. Two-thirds of students now graduate with student loan debt.

The average debt load has soared as well. In the past decade, it has increased by 57 percent at public colleges and 38 percent at private colleges. Today, the typical graduate leaves college saddled with $17,000 in student loans.

Nowhere has this growth been more pronounced than in private student loans. Until recently, most students who borrowed for college took out loans under the Direct Loan program and the Federal Family Education Loan program--the two main student loan programs subsidized by the Federal Government.

With the cost of college rising rapidly and grant aid stagnating, however, more and more students are turning to the private loan sector and are taking out so-called ``alternative loans'--private loans that lenders offer through colleges and universities. Students are also borrowing increasingly from direct-to-consumer education lenders, which include giant lenders such as Sallie Mae that also participate in the FFEL program, as well as other companies that just offer private-market loans, such as Loan to Learn.

A decade ago, private loans accounted for only 3 percent of all funds used to finance students' post-secondary education. Since then, the volume of private loans has grown by an astronomical 1200 percent. Today, private loans now total $17 billion, and represent 20 percent of all borrowing for higher education.

Many lenders making these private loans claim they're providing an important service. They say that at a time when college prices are rising rapidly, they provide needed funds to help students pay for college.

What they won't tell you is the exorbitant cost that countless students are paying for these loans. Unlike loans offered through the federal programs, private loans frequently carry much higher interest rates, especially for students without credit histories and families without strong credit ratings. In some cases, the interest rates on private loans may be as high as 19 percent a year, compared to 6.8 percent for loans offered through the FFEL and Direct Loan programs.

The lenders also don't tell you about the aggressive tactics they use to persuade colleges to offer private loans to their students--and to persuade students to borrow directly as well.

The private company Student Loan Xpress has offered 100 percent loan approval at colleges if the college agrees to ``brand' the private loan with the college's name and emblem--making the loan appear to be offered by the college, not the private lender.

Other private loan companies encourage borrowers not to fill out the Free Application for Federal Student Aid, which allows borrowers to obtain loans at lower interest rates. They don't prominently disclose the fact that their interest rates are typically much higher.

Some lenders make gifts to college and university employees. Loan to Learn invited college officials and their spouses to an all-expenses paid ``education conference' in the West Indies. Many lenders who participate in the FFEL program offer similar ``educational conferences' at fancy hotels, and offer free entertainment and tickets to sporting events to college officials. The Attorney General in New York State has opened an investigation into such practices and is looking into the practices of six lenders, including Sallie Mae, Nelnet, and Educap, the corporate name of Loan to Learn.

We need to take immediate steps to stop actions that prevent students from obtaining the best loan agreement possible. That is what the Student Loan Sunshine Act does.

First and foremost, it is a consumer protection measure. It will protect student and parent borrowers by ending the inappropriate lender practices I've just mentioned.

It prohibits lenders from offering to a college employee any gift worth more than $10, including free or discounted trips, meals, invitations to entertainment events or other form of hospitality.

It prohibits lenders from offering services to financial aid offices that create a conflict of interest, such as lending staff during peak loan processing times. It also prohibits lenders from ``branding' their loans with a college name, emblem, or logo.

The Sunshine Act also arms students and parents with the information they need to make wise decisions when they borrow funds for higher education.

The Act requires lenders to report any special arrangements they have with colleges to make such loans, and it ensures that this information is conveyed to borrowers.

It requires the Secretary of Education, together with members of the higher education community and students, to develop a clear, easy-to-use model format for reporting the terms and conditions of student loans, similar to the APR disclosure required for other types of loans.

If a college creates a ``preferred lender' list, the Act requires the college to disclose clearly and fully why it has identified a lender as a preferred lender. Schools must also include at least three nonaffiliated lenders on the list, so that students have a real choice. Finally, the Sunshine Act also addresses the fast-growing direct-to-consumer educational loan market. It offers new protections for students who take out direct-to-consumer loans, so they don't borrow more than is necessary to pay for their college education.

The Act requires all lenders of direct-to-consumer private educational loans to state clearly and prominently that borrowers may qualify for low-interest loans through the Federal Government's loan programs. It also requires lenders to clearly disclose the terms and conditions of the loans they're offering, including any hidden fees, as well as any complaints against the lender that have been filed by consumer agencies such as the Better Business Bureau or the state attorney general's office.

Before a direct-to-consumer lender can offer an education loan of more than $1000, the Act requires the lender to notify the borrower's college of the amount of the proposed loan, so that the school can advise the borrower whether the loan exceeds what's necessary to cover the student's cost of attendance after other aid sources are factored in.

Students deserve the best loan advice possible from financial aid officers and the best deal from lenders. They have the right to exhaust their federal loan eligibility before turning to more expensive private lenders for aid.

Going to college is a lifetime investment, but paying for college is a heavy burden for too many families. As the private student loan market continues to grow, it's our responsibility to protect students from exploitation in that market.

I thank the bill's cosponsors, and I urge my colleagues to support this bill as well. It's time we put students first, and the Student Loan Sunshine Act takes important steps to do just that.

I ask unanimous consent that the text of this bill be printed in the RECORD.

There being no objection, the text of the bill was ordered to be printed in the RECORD


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