Food and Drug Administration Amendments Act of 2007

Floor Speech

FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007

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Mr. KENNEDY. Mr. President, 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 U.S. economy. The agency does all this on a budget that amounts to less than 2 cents a day for each citizen.

Yesterday, the House of Representatives approved legislation on FDA reform by a broad bipartisan majority of 405 to 7. Our House colleagues from all parts of the political spectrum united to send that bill to the Senate with a resounding bipartisan endorsement. We cannot wait another month, another week--or even another day. We must take action here and take action now to send that bill to the President.

The stakes could not be higher. Funding for the FDA's vital safety mission is reaching the breaking point. Unless we act, the FDA Commissioner will send a letter tomorrow to over 2,000 employees informing them that their jobs are slated for termination. This legislation provides nearly $500 million in new resources for FDA--including over $50 million for drug safety and $6 million for review of direct to consumer ads.

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 is what we have before us today.

At the heart of our proposal is a new way to oversee drug safety that is flexible enough to be tailored the characteristics of particular drugs, yet strong enough to allow decisive action when problems are discovered.

A second major element of our legislation is a public registry of clinical trials and their results. A complete central clearinghouse for this information will help patients, providers and researchers learn more and make better health care decisions. Now, the public 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 establishing a new center, the Reagan-Udall Foundation, to develop new research methods to accelerate the search for medical breakthroughs.

The bill helps preserve the integrity of scientific review by improving FDA's safeguards against conflicts of interest on its scientific advisory committees, and it will end the abuse of citizens petitions that are too often used not for their intended purpose of brining important public health concerns to the attention of the FDA, but rather to delay the approval of generic drugs.

The proposal before the Senate today strikes the right balance on this issue. It rightly states that the mere filing of a citizen petition should not be cause for delay, but allows FDA to delay the approval of a generic application if it determines that doing so is necessary to protect public 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 thank Senator Roberts and Senator Harkin for working with Senator Enzi and me and with many members of the committee on this important provision.

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

Our legislation also takes important first steps toward a safer food supply. These are only first steps--our committee will work on a comprehensive package of food safety legislation in the fall--but they are important steps. Consumers and FDA have too little information about contaminated food. Our bill creates a registry and a requirement to report food safety problems. Consumers will have information about recalls at their fingertips, and FDA's response will not be slowed by antiquated and inefficient reporting systems. Our bill also establishes strong, enforceable quality standards for the food we give our pets, to guard against the problems of tainted pet food that we have seen in recent months.

In this new era of the life sciences, medical advances will continue to bring immense benefits for our citizens. To fulfill the potential of that bright future, we need not only brilliant researchers to develop the drugs of tomorrow, but also strong and vigilant watchdogs for public health to guarantee that new drugs and medical devices are safe 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 this bipartisan consensus bill can do the job. I ask my colleagues to approve this needed legislation without delay.

H.R. 3580, the Food and Drug Administration Amendments of 2007, does a great deal to improve the regulatory process and to strengthen FDA's ability to enforce drug safety standards, particularly in the postmarket period. A recent study by the Institute of Medicine described FDA's post-market drug safety authority as ``aging and inadequate.'' Currently, FDA's ability to address potential health problems that become known after the drug has gone on the market is very limited. This is a serious weakness in the present system that must be corrected. This legislation will give FDA the authority, for the first time, to compel a drug company to add warnings of newly discovered risks on the drug label. As a result, in many cases the health risks involved in using potentially dangerous drugs will be disclosed to the public much sooner than they are today.

At the same time, this legislation makes clear that drug companies will continue to have the same independent responsibility to update the warning labels on their drugs in the future that they have under current law today. If a drug company learns of new dangers that its product potentially poses to the patients taking it, the company has a legal responsibility to immediately warn those patients of the risk of injury.

By enacting this legislation, we do not intend to alter existing state law duties imposed on a drug manufacturer to obtain and disclose information regarding drug safety hazards either before or after a drug receives FDA approval or labeling. We do not believe that the regulatory scheme embodied in this act is comprehensive enough to preempt the field or every aspect of state law. FDA's approved label has always been understood to be the minimum requirement necessary for approval. In providing the FDA with new tools and enhanced authority to determine drug safety, we do not intend to convert this minimum requirement into a maximum. The Institute of Medicine and others have found that FDA's past performance has been inadequate. While we fully expect substantial improvement as a result of the enactment of this bill, we cannot and do not expect the FDA or this new process to identify every drug specific safety concern before a drug manufacturer becomes aware or should have become aware of such concerns. Nor are the bill's requirements that companies disclose certain safety information to the government intended to substitute for the disclosure requirements that may be required under state law.

No one should be under the mistaken impression that the new authorities and resources provided under H.R. 3580 lessen in any way the obligation of a drug company to scrutinize vigilantly the safety signals for their drugs and proactively study such signals or change their labels when the evidence supports such a change. This new postmarket authority for FDA is not intended to alter the drug companies' independent obligation to promptly warn consumers of a drug's risks. Under current FDA regulations, a drug company is required to add new warnings to its labels as soon as it learns about new risks potentially posed by its drugs. The company must add the new warning even if FDA has not required a labeling change.

It is worth putting the situation in a little perspective. The legislation increases FDA's resources for post-market drug safety efforts significantly. FDA's current resources of about $25 million are increased by almost $55 million in the first year, to nearly $80 million. There will be increases in the next four years of $10 each year, so that FDA's post approval drug safety budget will be at about $120 million in 2012. This is the entire budget at the FDA to collect and analyze post-market safety information and respond with appropriate regulatory action. FDA must use these resources to police every prescription drug on the market--thousands of drugs.

By contrast, the drug industry had annual revenues in 2005 of over $200 billion. To be sure, significant portions of these revenues support research and development, profits, and marketing of drug products, but a mere 1 percent of these sales exceeds the entire budget of the FDA. It exceeds the agency's budget for postmarket drug safety by a factor of over one thousand. Many major brand drugs have annual revenues that exceed FDA's annual budget for postapproval drug safety. Consider the top 200 selling drugs in 2006: Merck's drug Fosamax Plus D came in 200th in 2006, with U.S. sales of $140 million. Sales from this one drug alone exceed the entire $120 million FDA budget for drug safety in the last year of this program. The 100th drug, Abbott's Kaletra, had 2006 sales of $350 million, nearly three times the FDA's annual drug safety budget for 2012. Thirtyeight drugs had U.S. sales exceeding $1 billion in 2006. The top selling drug, Pfizer's Lipitor had 2006 sales of nearly $6.6 billion, an amount more than 50 times FDA's annual drug safety budget in 2012 under this legislation.

Clearly, the resources of the drug industry to collect and analyze postmarket safety data vastly exceed the resources of the FDA, and no matter what we do, they will always have vastly greater resources to monitor the safety of their products than the FDA does. It is absurd to argue that the FDA, even with the enhanced resources and authorities provided by this legislation, commands the field when it comes to postmarket drug safety. The drug companies have the capacity to do a far more comprehensive job. If we are serious about quickly alerting the public to the health risks posed by drugs, the companies must be required to take the initiative in monitoring the safety of their products and immediately warning the public of newly discovered risks. Drug manufacturers cannot be allowed to ignore their responsibility and wait for the FDA to act.

To be sure, the legislation gives FDA the authority to command some of the resources of a drug company. FDA can order an epidemiological study or even a clinical trial, but this authority is not unlimited. Certain standards must be met before FDA can act to require a drug company to investigate a safety signal.

Importantly, a drug company has the ability and the responsibility to conduct these studies or clinical trials on its own initiative. Nothing in H.R. 3580 requires a company to wait and react to an order from the FDA for such a study or clinical trial, or to wait for FDA to order the company to change its label. The legislation retains the current, ongoing requirement, found in section 502(a) of the Federal Food, Drug, and Cosmetic Act, for a drug company to ensure that its label is not false and misleading. This statutory imperative is recognized in current FDA regulations. Section 901 of H.R. 3580 cites these regulations in the new section 505(o) of the Federal Food, Drug, and Cosmetic Act. These regulations obligate a company to propose a labeling change to enhance a warning or improve safety information without waiting to hear from FDA, and allow the company to implement the labeling change before the FDA has reviewed and approved the change.

In most cases, a drug company will learn about new risks from its product before the FDA does. Usually, it is the manufacturer that possesses the information demonstrating a potential danger from the product. It is imperative that patients and health professionals learn about those new health risks as quickly as possible. For that reason, drug companies have, and must continue to have, an independent duty to warn drug users of the danger as soon as the company becomes aware of it. Otherwise, there will be long delays before consumers are alerted, and the number of injuries caused by the product will multiply.

What should motivate a drug company to investigate drug safety signals and take appropriate action to mitigate a safety risk? You can find the answer in several places: from the simple moral duty to do the right thing; from the duty to one's customers, who use one's products with the understanding, often promoted by direct-to-consumer advertising, that the company's highest interest is to bring safe and effective cures to the sick and ill of the Nation; and from a duty under State law to offer products that are free of defects, with adequate warnings about their risks. This legislation changes none of these duties, in any way, whether they arise from simple ethics, principles of contract law, or of tort law. Rather, the legislation provides FDA with additional resources and authority to be better able to step in when a company fails to live up to these responsibilities.

But some drug companies don't want to fully inform the public about these risks to patients' health, and they don't want to be held accountable when patients are injured or killed by their drugs. They would have liked this legislation to change the law to escape this responsibility. These drug companies wanted to convert FDA regulation from a safety floor into a ceiling, from a minimum safety standard designed to protect consumers into a liability shield designed to protect the drug companies. But Congress firmly rejected this approach.

If companies were allowed to conceal safety information until the FDA ordered them to disclose it, consumers would continue taking these dangerous drugs without knowing their risks for months or even years after the risks were discovered. Then, when the public finally learned of the risk, the drug company would be immune from suit for failing to warn its customers. Those who were seriously injured by the drug would have no legal recourse, even though the company had concealed the risk. The company would completely escape accountability for its failure to warn consumers. That would be totally unacceptable, and is not what we intend by this legislation.

Regulation by the Food and Drug Administration and product liability lawsuits against the manufacturers of harmful drugs work together to protect consumers. Both are needed to force drug companies to disclose health risks posed by their products as soon as those risks are discovered. Both are essential to identifying dangerous drugs and getting them off the market quickly. Effective regulation by the federal government and litigation by victims of dangerous drugs work hand-in-hand to keep patients safe and make drug companies more responsible. This legislation improves FDA oversight of postmarket drug safety, and does not undermine or preempt the efforts by injured patients to seek redress under State product liability law.

Congress has stated very clearly in the legislation that we do not intend the new authority being given to FDA to preempt common law liability for a drug company's failure to warn its customers of health risks. The legal duty of drug companies to warn consumers of the health risks of their products as soon as those risks are discovered is essential to effectively protecting the public from dangerous drugs. Legislation designed to protect consumers from dangerous drugs must not be distorted into a shield protecting drug companies from accountability.

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MEDICARE CLAIMS DATA

Mr. KENNEDY. It is a great pleasure to work with my distinguished colleagues from the Finance Committee on this reauthorization of important programs at the FDA. I know they have a deep interest in seeing that the medicines that Americans take are safe and effective.

Senator Baucus and Senator Grassley have rightly raised a question regarding the interpretation of section 905 of this bill. Section 905 adds a new paragraph (3) to section 505(k) of the Federal Food, Drug and Cosmetic Act. This new paragraph establishes a system for FDA to query databases regarding information that may help detect adverse drug effects. It is essential to detect drug safety problems early, so that they may be corrected before people are hurt and an electronic drug safety system is one important tool for doing so.

The Medicare claims database is listed as one of several possible sources of data in section 505(k)(3)(C)(i)(III)(aa). I want to assure my friends from Montana and Iowa that our intent is that Medicare's participation will be determined by provisions of the Social Security Act, over which the Finance Committee has exclusive jurisdiction. Nothing in this section is intended to infringe on that jurisdiction or to in any way preempt the ability of the Finance committee to act to specify the participation or nonparticipation of the Medicare claims data base in the system established under section 905.

The matter before the Senate amends the Federal Food, Drug and Cosmetic Act. The section to which you have raised concerns authorizes use of Medicare data ``as available.'' I acknowledge that under current law, that is not possible.

Mr. BAUCUS. I thank the chairman. I intend to continue working with my good friend Senator Grassley to address the release and use of Medicare data by Federal health agencies and private researchers soon through legislation written by the Finance Committee.

Mr. GRASSLEY. I agree with my colleague, Senator Baucus. I have been working a long time on legislation to permit the use of Medicare data to improve drug safety. After all this is some of the best and most complete data available. In fact, Senator Baucus and I joined together to introduce legislation to accomplish just that during the 109th Congress, S. 3987, the Medicare Data Access and Research Act, and this Congress, S. 1507, the Access to Medicare Data Act of 2007. Improving drug safety is a top priority of mine and the appropriate use of Medicare data will likely enhance drug safety. That will benefit all Americans. I look forward to completing our goals for Medicare data later this year and including this on legislation within the purview of the Finance Committee. We intend to clarify how Federal health agencies may use and release Medicare data and make the appropriate amendments in the Social Security Act. At that point, it will be important that the use of Medicare data be appropriately tied into the drug safety provisions of the FDA bill under consideration today. We would hope that our colleague, Senator Kennedy, would agree to make conforming amendments to the Federal Food, Drug and Cosmetic Act as needed to make FDA law consistent with appropriate Medicare law.

Mr. KENNEDY. I appreciate that conforming amendments in the Federal Food, Drug and Cosmetic Act may be necessary as you point out. I agree to work with the Senator in the future on this issue.

Mr. KENNEDY. Mr. President, I ask unanimous consent that the bill be read a third time, passed, the motion to reconsider be laid upon the table, and that any statements relating to the bill be printed in the Record, without further intervening action or debate.

The PRESIDING OFFICER. Without objection, it is so ordered.

The bill (H.R. 3580) was ordered to a third reading, was read the third time, and passed.

Mr. KENNEDY. Mr. President, the New England Journal of Medicine, which is probably the most distinguished medical journal in not only this country, probably in the world, has made the comment that this legislation is the greatest progress, in terms of drug safety, in a century. This ought to be reassuring for every family as to the safety of their prescription drugs and also in terms of their food.

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