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Public Statements

Prescription Drug User Fee Amendments of 2007

Floor Speech

Location: Washington, DC



Mrs. CLINTON. Madam President, for many years, the FDA has been considered the gold standard among the world's drug safety bodies. And no one here doubts the desire of the agency's many career employees to continue to carry out its mission of keeping our drug supply safe for all Americans. In the legislation we are considering today, S. 1082, the Food and Drug Administration Revitalization Act, we provide these dedicated employees with the resources necessary to continue their work to ensure the safety and efficacy of drugs and biologic products for Americans.

Despite the dedication of the FDA's employees, we know there have been breakdowns at the agency. We know that, at times, it has taken too long to act when a drug may pose a threat. It took many months from the point when scientists became aware of the elevated risk of adverse cardiovascular events associated with Vioxx and the point when it was withdrawn from the market, during which time the FDA had multiple opportunities to engage in stronger actions to protect consumers.

In recent years, we have seen the scientific process unduly influenced by political or economic factors. When Senator Patty Murray and I worked to secure a decision for over-the-counter availability of Plan B, we saw the ways in which science-based decisionmaking was compromised. The Government Accountability Office has confirmed that the FDA's 2004 decision not to approve over-the-counter sales of Plan B was politically motivated. Concerns about undue influence from factors other than science extend beyond this one example. According to a Union of Concerned Scientists survey, 61 percent of FDA scientists could cite examples of when ``Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations of actions.'' Twenty percent of those responding had been ``asked explicitly by FDA decision makers to provide incomplete, inaccurate, or misleading information ``

Because of these examples, I believe that the American public lost a great deal of confidence in the ability of the agency to ensure the safety of their medications. With this legislation, we can begin the process of rebuilding consumers' confidence in the FDA. Through this bill, we are taking concrete steps to improve drug safety. S. 1082 establishes steps to establish a routine active surveillance system for medications and sets up a process through which the FDA can better manage risks for a range of drugs, from requiring postmarket studies to improving communication about the risks and benefits associated with medications.

In addition to establishing a framework to increase drug safety, we are also working to implement an atmosphere where science guides the agency's decisions. We need to put into place the systems to ensure that employees can engage in the open, evidence-based discourse needed as part of the drug approval and review process--discourse not unduly influenced by political concerns. This legislation goes a long way to doing some of that by increasing the transparency around drug approval decisions, addressing conflicts of interests on advisory committees, and creating a climate that protects the rights of employees to publish in peer-reviewed scientific journals.

I know that many of my colleagues have raised concerns about safety in the context of reimportation of drugs, and I am pleased to note that on this legislation, we have found a way to allow for safe drug reimportation. S. 1082 contains the provisions of Senator Dorgan and Snowe's Pharmaceutical Access and Drug Safety Act, legislation I am proud to cosponsor. This amendment would establish the framework through which we could phase in drug reimportation from other nations where regulatory authority is similar to that in our country, allowing millions of Americans to safely obtain medically necessary drugs at lower cost.

Americans pay higher prices for the exact same prescription drugs being taken by their counterparts in Canada and Europe. The Congressional Budget Office has found that prices for brand-name prescription drugs are 35 percent to 55 percent higher in the United States. This price disparity affects millions of Americans. Our seniors, many of whom are on fixed incomes, end up spending larger portions of their income on drugs, especially when falling into the ``doughnut hole'' or wrestling with other gaps in a Medicare Part D benefit. And this isn't only a problem for seniors--we have 46 million uninsured individuals in our country, many of whom are unable to afford prescription drugs. Without these drugs, manageable chronic conditions, like asthma or high blood pressure, spiral out of control into serious health problems.

The lack of affordable drugs does not just hurt those who are uninsured or underinsured, but it also places greater pressure upon our health care system. The cost of treating someone in the emergency room is much higher than the cost of a prescription. But the way our system is set up, we don't help people engage in cost-effective disease management by making those drugs affordable, and I believe that we need to examine the ways in which importation can lower costs not only for consumers but for our overall system.

The Dorgan-Snowe amendment contains many provisions that will ensure safety while giving Americans access to cheaper drugs. This bipartisan provision will allow seniors to safely access drugs from Canada starting 90 days after enactment. It will provide the needed authority and funding to the FDA to regulate foreign pharmacies and wholesalers, so that we can be sure that any drugs that enter the United States are safe for our citizens. And it will increase the consumer protections involved with internet pharmacies, so that people who don't live near the border can access imported drugs without being defrauded.

We need to make drug reimportation safe, we need to make drug reimportation unambiguously legal, and we need to do so as quickly as possible. The Dorgan-Snowe amendment would allow us to do all of those things, and I would urge all of my colleagues to support this amendment to the bill.

In addition to the provisions of this legislation dealing with drug safety and reimportation, I am proud to note that the Food and Drug Administration Revitalization Act has an entire title devoted to pediatric issues. I worked with Senators Dodd, Kennedy, and Enzi to craft these provisions, which will be of great benefit to children. The pediatric device provisions will help us improve the number and types of medical devices designed for pediatric populations, and the reauthorization of the Best Pharmaceuticals for Children Act improves the applicability of the pediatric exclusivity incentive and increases the speed through which these studies can be requested by the FDA. When this bill was passed in 2002, I was able to work with Senator Dodd and the HELP Committee to increase provisions to assist pediatric cancer research, and I am pleased to be a cosponsor of this legislation this time around.

S. 1082 also contains most of the provisions of the Pediatric Research Improvement Act, a bill that I introduced earlier this year to reauthorize the pediatric rule. Because of this authority, the Food and Drug Administration is able to ensure that drugs that are marketed for children are safe and effective in children.

For the past decade, I have been working to ensure that drugs that are marketed to children are safe and effective in children. As of the early 1990s, only about 20 percent of drugs contained specific pediatric dosing information, but since 1998, we have had over 1,000 drugs fall under the scope of the pediatric rule, resulting in hundreds of studies that have helped us gain valuable data about drugs commonly used by kids.

The reauthorization of the pediatric rule contained in this larger bill will allow us to make additional strides in improving pediatric drug development. We will be able to remove unnecessary bureaucratic barriers and improve the ability of the Food and Drug Administration to require testing on already-marketed drugs when sponsors refuse to carry out such testing under the incentive provided by the Best Pharmaceuticals for Children Act.

It will improve our ability to collect and analyze data about pediatric clinical trials so that we can better evaluate the impact of such trials upon children's health overall, and it will improve the FDA's ability to coordinate the incentives provided under Best Pharmaceuticals for Children Act with the pediatric rule so that these two pediatric programs of the agency can work together more seamlessly.

However, I must note that I am disappointed that this bill does not consider what I believe to be a critical part of the Pediatric Research Improvement Act--the provision which would have made permanent the authority of the FDA to obtain important data through the pediatric rule.

Instead, the legislation before the Senate today contains a sunset of this authority, meaning that if this provision isn't reauthorized 5 years from now, the FDA will no longer be able to ensure that drugs used in children are safe and effective in children.

We would never dream of placing a sunset on the FDA's authority to certify the safety and efficacy of drugs used in adults, and I fail to understand why we impose a different standard on drugs for children, and I will seek to address this issue as the bill moves forward.

We must also improve the FDA's authority in the realm of follow-on biologics. While there is nothing in the version of the legislation that is on the floor today that addresses this issue, Senators Kennedy and Enzi have made a commitment that we will mark up legislation on this issue on June 13 in the HELP Committee and that we will incorporate this legislation into the conference negotiations on this drug safety bill.

Earlier this year, in conjunction with a number of bipartisan cosponsors, I introduced the Access to Life-Saving Medicine Act, legislation to provide FDA with the authority to approve safe and effective generic versions of biotech drugs. By bringing safe and effective follow-on biologics to the market, we can provide significant savings to patients, employers, and the government.

More than $10 billion worth of biopharmaceuticals will come off patent in the next 5 years, and without this legislation, the manufacturers of these biotech drugs can continue to charge monopoly prices indefinitely. In 2005, the costs of biologics grew 17.5 percent compared to traditional drugs, which increased 10 percent. And in 2006, the Medicare Part B Program spent more than $5 billion on biologic drugs. It is clear that biotech drugs hold great promise, but this promise is wasted if we don't take action to ensure that all Americans have access to safe, effective, and affordable generic versions of these drugs.

According to a report released by Engel and Novitt to the Pharmaceutical Care Management Association, PCMA, passage of this legislation could conservatively save an estimated $14 billion over the next 10 years.

I look forward to working with Senator Kennedy and my colleagues on the HELP Committee to ensure that we enact legislation that provides the FDA with the authority and flexibility to approve biopharmaceuticals subject to a workable, abbreviated approval pathway that is efficient, effective, and scientifically grounded and that includes measures to ensure timely resolution of patent disputes, as well as adequate incentives for continued innovation.

Another issue that has come up during debate on the Food and Drug Administration Revitalization Act is food safety. Recent illnesses involving E. coli in spinach and lettuce, the discovery of Salmonella in peanut butter, and the importation of unsafe pet food ingredients from China illustrate the continued vulnerability of the American food supply and expose weakness in the FDA's food safety program.

In the latest case, a chemical used in plastic manufacturing was placed in feed material from China, causing the deaths of an unknown number of pets. This chemical was also consumed by 2.7 million chickens and 345 pigs that were slaughtered for human consumption. Our food system must be prepared to effectively prevent the chemicals found in these animals from endangering the health of consumers.

That is why I supported the inclusion of certain provisions in this bill to begin to address many of the agency's problems with food safety, as a prelude to overall committee action on this issue.

I have long been concerned about the siloing of authority at the FDA and Department of Agriculture, and I filed an amendment to this bill which would establish a joint task force between the FDA, U.S. Department of Agriculture, USDA, and the Centers for Disease Control and Prevention (CDC) to improve our response to foodborne illnesses.

According to the CDC, unsafe foods cause an estimated 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths each year. Despite these statistics, safety tests for domestically produced food have dropped nearly 75 percent when compared to the number conducted in 2003. Meanwhile, the number of food imports has grown from under 4 million food import line items in 1993 to nearly 20 million in 2007. We have a situation where inspections are declining, yet the number of outbreaks and contaminations in our food supply is on the rise. The fragmentation in our food safety system must be addressed in order to protect consumers.

With several of my colleagues, I have repeatedly written to the Secretary of Agriculture, the Commissioner of the FDA and the Director of the CDC urging them to create an interagency task force to better enable us to prevent such illnesses. To date, no action has been taken to grant my request. If the delay is due to concerns that these agencies do not have the authority to pursue such authority, I stand prepared, along with many others in the Senate, to provide these agencies with such authority. I look forward to working with my colleagues in the HELP Committee to address concerns about food safety and help restore our Nation's confidence in the ability of both these agencies to protect American consumers.

I would like to close by noting that while the Food and Drug Administration Revitalization Act takes several steps that will improve the agency's ability to ensure the safety and effectiveness of drugs and biologics, it is time that we begin to look at drugs in a new way.

It is not enough that we have drugs that are effective--in order to reduce overall health care costs, we need to understand how these drugs are effective in comparison to each other, in order to assist providers and patients make the best health care decisions.

While the Vioxx controversy highlighted the need for additional safety protections, many of which are contained in the Food and Drug Administration Revitalization Act, it also demonstrates the role comparative effectiveness can play in ensuring the use of the most appropriate treatment for a specific condition. I pushed for inclusion of comparative effectiveness studies in the Medicare Modernization Act. One of the first studies to be carried out under this provision was a systematic review of osteoarthritis drugs, including Cox-2 drugs. If this information had been compiled earlier, it could have helped many evaluate whether to use these drugs, as opposed to other pain relievers, many of which are available at a lower cost without a doctor's prescription.

Comparative effectiveness assists physicians and patients in selecting the best treatment and helps to reduce inappropriate uses of treatments that pose unnecessary safety risks to patients--and more and more people are recognizing its potential in improving health care. Earlier today, the Blue Cross and Blue Shield Association announced their support to create a new, independent entity to explore the effectiveness of new and existing medical procedures, drugs, devices, and biologics. I am grateful for their leadership, and I will be introducing legislation shortly to expand comparative effectiveness research and its use at the Federal level.

I have been involved in the debate over the Food and Drug Administration Revitalization Act for several months now and believe that the product we have produced represents a step forward for safety. I will be supporting this legislation and look forward to working with my colleagues to ensure that we can continue to strengthen this agency, lower prescription drug costs, and maintain a strong commitment to consumer protection and scientific innovation.

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