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Statement of Senator Edward M. Kennedy on the Passage of the Food and Drug Amendments Act of 2007

(As Prepared for Delivery)

Every day, families across America rely on the Food and Drug Administration in ways they barely realize. When they put dinner on the table, they are counting on FDA to see that it is free from contamination. When they care for a sick child, they are trusting FDA to make sure the drugs prescribed are safe and effective. From pacemakers to treatments for cancer to the foods we eat, FDA protects the health of millions of Americans, and oversees products that account for a quarter of the US economy. The agency does all this on a budget that amounts to less than two cents a day for each citizen. An agency that does so much so well deserves to be supported and strengthened. Yet too often, the opposite has been true. FDA's vital mission has been jeopardized by inadequate resources, occasionally insufficient legal authority, and absent leadership.

Americans are worried about the safety of the products they use – from food to toys to drugs – and they are right to be worried. Dangerous lapses in safety oversight have exposed American families to intolerable risks from lead paint in toys, to bacteria in foods, to drugs that cause unreported and lethal side effects. The right response is comprehensive, considered and bipartisan legislation – and that’s what the Senate has approved.

The prestigious New England Journal of Medicine editorialized earlier this yearthat the bill was “the most important drug-safety legislation in a century.”Earlier this week, the House of Representatives approved this bipartisan measureby a broad bipartisan margin of 405 to 7. Our House colleagues from all parts of thepolitical spectrum united to send that bill to the Senate with a resounding bipartisanendorsement. I am pleased that the Senate did the same, sending that bill to the Presidentwith a unanimous voice of approval.

The stakes could not be higher. Funding for the FDA’s vital safety mission hasreached the breaking point. If we had not acted, the FDA Commissioner would have senta letter today to over 2,000 employees informing them that their jobs were slated fortermination.

Each of those individuals is a trained and experienced professional with manycareer options in academia or industry – yet each of them has made the decision to devotethemselves to public service. If those talented public servants had left the agency,the consequences would have been with us for years – in terms of slower access tomedicines for patients, weaker safety oversight and loss of America’s competitive edge inthe life sciences.

FDA has an urgent need for these funds. Its work load has increased massively inrecent years but its resources have not kept pace. Since 1990, the number of adverseevents submitted to the FDA has increased by over 1,300 percent, but the agency’sresources have increased only 130 percent. The legislation provides over $400 millionthis year for the review of drugs and medical devices at FDA, and over $50 million forneeded safety reforms to give these talented professionals the tools they need to do thejob we are counting on them to do.

The bill before us is not just about resources – far from it. It is a strong andcomprehensive measure to improve the safety of the medicines we rely on, and it takesimportant steps toward a safer food supply and less expensive prescription drugs.At the heart of our proposal is a new way to oversee drug safety that is flexibleenough to be tailored the characteristics of particular drugs, yet strong enough to allowdecisive action when problems are discovered. For drugs that pose little risk, theseactions might be as simple as a program to report side effects and a label with safetyinformation – items that are currently required for all drugs. Drugs that raise majorpotential safety concerns might require additional clinical trials, a program to trainphysicians in using the drug safely, or a requirement that the prescribing physician havespecial skills.

A second major element of our legislation is a public registry of clinical trials andtheir results. A complete central clearinghouse for this information will help patients,providers and researchers learn more and make better health care decisions. Now, thepublic will know about each trial underway, and will be able to review its results.Our bill recognizes that innovation is the key to medical progress by establishinga new center, the Reagan-Udall Foundation, to develop new research methods toaccelerate the search for medical breakthroughs. During the discussions that led toconsideration of this bill, we heard time and again that there was a major need for betterresearch tools to aid FDA in evaluating the safety of drugs and devices and helpresearchers move through the long process of developing these products more effectively.If new research tools and better ways to evaluate the safety and effectiveness ofdrugs could be developed, patients will benefit from quicker drug development. Ifcurrent procedures can be made more effective, then the cost of developing new drugswill drop.

The Reagan-Udall Foundation sets up a way to develop these new tools – not sothey can help just one researcher or one company, but so they can help the entire researchenterprise.

The bill helps preserve the integrity of scientific review by improving FDA’ssafeguards against conflicts of interest on its scientific advisory committees – not througha rigid policy that could deny FDA needed expertise, but though a flexible approach thatwill reduce the number of waivers given for conflicts of interest at FDA overall.The bill also takes action on the abuse of citizens petitions. FDA has a commonsense policy to allow ordinary citizens or medical experts to submit petitions to theagency about drugs that it is considering approving. This procedure should be used toprotect public health – but too often, it is subverted by those who seek only to delay theentry onto the market of generic drugs.

Even if the petitions are found to be meritless, they will have accomplished theirmission – delaying access for consumers to safe and lower cost medicines. Somepetitions do present legitimate public health concerns, and FDA should not ignore them.The critical test of any proposal on citizen petitions is that it strike a balance so that theabuse of citizens petitions is prohibited, but those petitions that have genuine safetyinformation are reviewed.

The proposal the Senate approved strikes that balance. It rightly states that themere filing of a citizen petition should not be cause for delay, but allows FDA to delaythe approval of a generic application if it determines that doing so is necessary to protectpublic health. This is the right approach. It prevents abuse, but protects health.The legislation also includes important reforms of direct to consumer, or DTC,advertising. I want to thank Senator Roberts and Senator Harkin for working withSenator Enzi and me and with many members of the committee on this importantprovision.

Instead of the moratorium included in our original bill, the current proposal putsin place strong safety disclosures for DTC ads, coupled with effective enforcement.Under current law, safety disclosures can be an afterthought – a rushed disclaimer readby an announcer at the conclusion of a TV ad while distracting images help gloss over theimportant information provided. Our proposal requires safety announcements to bepresented in a manner that is clear, conspicuous and neutral, without distracting imagery.We also give FDA the authority to require safety disclosures in DTC ads if the riskprofile of the drug requires them.

Our legislation also takes important first steps toward a safer food supply. Theseare only first steps, and our committee will work on a comprehensive package of foodsafety legislation later in the fall – but they are important steps. Consumers and FDAhave too little information about contaminated food. Our bill creates a registry and arequirement to report food safety problems. Consumers will have information aboutrecalls at their fingertips, and FDA’s response will not be slowed by antiquated andinefficient reporting systems. Our bill also establishes strong, enforceable qualitystandards for the food we give our pets, to guard against the problems of tainted pet foodthat we have seen in recent months.

In this new era of the life sciences, medical advances will continue to bringimmense benefits for our citizens. To fulfill the potential of that bright future, we neednot only brilliant researchers to develop the drugs of tomorrow, but also strong andvigilant watchdogs for public health to guarantee that new drugs and medical devices aresafe and beneficial, and that they actually reach the patients who urgently need them.Congress has ample power to restore the luster the FDA has lost in recent years, and thisbipartisan consensus bill can do the job. I congratulate my colleagues on approving thislegislation, and look forward to working with them on its effective implementation.