Mr. DODD. Mr. President, I rise today to join Senator Grassley in announcing the introduction of the Food and Drug Administration Safety Act of 2005 (FDASA). I would like to thank Senator Grassley for his commitment to this issue and his willingness to work on this important legislation in a bipartisan manner. Senator Grassley and I have spent the past several months crafting this legislation, which will create a new center within the FDA that will be responsible for ensuring that prescription drugs are safe once they are on the market.

Our hope is that the creation of this new center will restore confidence in the medicines that so many Americans rely on to safeguard their health and well-being. Patients should be able to rest-assured that the drugs they take to help them will not hurt them instead.

Mr. President, the American pharmaceutical industry is a true success story. Their incredible innovations over the last few decades have saved and improved millions of lives, and made prescription drugs an integral part of quality health care. I am proud to say that Connecticut is home to a number of leading pharmaceutical companies. There is very little question that the American drug industry is the world leader. This is due, in no small part, to the FDA. Throughout the world, the FDA seal of approval - the words "FDA Approved" - has stood as the gold standard for safety and quality.

Unfortunately, events of the past year have put patients at risk and have seriously tarnished the FDA's image. Recent developments have cast into doubt the FDA's ability to ensure that the drugs that it approves are safe - especially once they are on the market. These concerns are bad for patients, bad for physicians, and bad for the drug industry.

Like many Americans, I have been deeply disturbed by the revelations of significant risk associated with widely used medications to treat pain and depression. These revelations raise real and legitimate questions about the safety of drugs that have already been approved. It would be one thing if these drugs were in a trial phase, but safety issues are being identified in drugs that are already on the market and widely used. Health risks significant enough to remove drugs from the market or significantly restrict their use are becoming clear only after millions of Americans have been exposed to real or potential harm.

It has been estimated that more than 100,000 Americans might have been seriously injured or killed by a popular pain medication, while millions of children have been prescribed antidepressants that could put them at risk. This recent spate of popular medicines being identified as unsafe underscores the need to take additional steps to monitor and protect patient safety after a drug has been approved.

Mr. President, the legislation that Senator Grassley and I are introducing today will do three things to restore confidence in the words "FDA Approved," and ensure that the FDA has all the tools that it needs to protect patients. First and foremost, it will establish within the FDA a new center – the Center for Postmarket Drug Evaluation and Research (CPDER) – which will report directly to the FDA Commissioner and be responsible for ensuring the safety and effectiveness of drugs and biological products once they are on the market.

I strongly believe that the creation of such a new, independent center is necessary. There have been disturbing reports that suggest that the FDA does not place enough emphasis on drug safety, and that concerns raised by those in the Office of Drug Safety (ODS) are sometimes ignored and even suppressed. An internal study conducted by the HHS Office of the Inspector General in 2002 revealed that approximately one-fifth of drug reviewers had been pressured to approve a drug despite concerns about safety, efficacy, or quality. In addition, more than one-third said they were "not at all" or only "somewhat" confident that final decisions of the Center for Drug Evaluation and Research (CDER) adequately assessed safety. The creation of a new center will raise the profile of drug safety within the agency.

Second, our bill will provide the Director of CPDER with significant new authorities, including: the authority to require drug companies to conduct postmarket studies of their products if there are questions about safety or effectiveness; the authority to take corrective actions (such as labeling changes, restricted distribution, and other risk management tools) if an unreasonable risk exists; the authority to review drug advertisements before they are disseminated, and to require certain disclosures about increased risk; and in extreme cases, the authority to pull the product off the market.

These new authorities will allow the FDA to act quickly to get answers when there are questions about the safety of a drug, and to act decisively to mitigate the risks when the evidence shows that a drug presents a safety issue. With these authorities, we will never again have a situation where a critical labeling change takes two years to complete, as was the case with Vioxx. When we are talking about drugs that are already on the market and in widespread use, any delay can put millions of patients in harm's way.

Third and lastly, this legislation will authorize the appropriation of $500 million over the next 5 years to provide the new center with the resources to carry out the provisions of this legislation.

Mr. President, I would like to thank several groups that have endorsed this bill, and that were instrumental in its drafting, including Consumer's Union, the Elizabeth Glaser Pediatric AIDS Foundation, the National Organization for Rare Disorders (NORD), the National Women's Health Network (NWHN), the U.S. Public Interest Research Group (PIRG), the Consumer Federation of America, and the Center for Medical Consumers.

I look forward to working with all of my colleagues, including Senator Enzi and Senator Kennedy on the HELP Committee, to see this legislation enacted as soon as possible. By strengthening the ability of the FDA to ensure the safety of prescription drugs once they are on the market, this legislation will allow physicians to prescribe, and patients to use, prescription drugs without wondering if the medicines intended to help them will hurt them instead. It will help ensure that the term "FDA-Approved" will remain the gold standard for safety and quality.