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The "Swift Approval, Full Evaluation (Safe) Drug Act"

Location: Washington, DC

THE ``SWIFT APPROVAL, FULL EVALUATION (SAFE) DRUG ACT'' -- (Extensions of Remarks - July 27, 2006)


* Mr. MARKEY. Mr. Speaker, I rise today to introduce the Swift Approval, Full Evaluation (SAFE) Drug Act. This bill is designed to ensure that the FDA can balance the need to get important life-saving drugs to the market quickly while ensuring the drugs get the full evaluation they need to ensure the safety of those products. A strong postmarketing study system allows the FDA to achieve a careful balance between speed of approval and careful scrutiny of the products. However, as both the GAO and the Inspector General of HHS recently reported, the system to ensure that postmarketing studies are conducted and completed is broken and the FDA has not made reform a priority.

* Postmarketing studies are important because they prevent death, detrimental reliance and waste. They provide critical information about the risks and benefits of a drug after it has been approved and on the market. They can also provide additional information about optimal use of the product and what groups of people are most likely to benefit (or not benefit) from use. Since the long-term effects of products are not usually studied prior to approval, postmarketing studies provide critical information about the risks or benefits of long-term use. Postmarketing studies allow the FDA to approve drugs for to consumers who need them quickly while ensuring that scientists will continue to investigate the best uses of the drug. These studies are particularly important when, in the interest of speeding drugs to consumers, the drugs are approved under the FDA's accelerated approval process.

* In 1992, the Food and Drug Administration, FDA, established a process that amounted to a trade-off between its mission to ensure drug safety and effectiveness and the need to speed promising new drugs to market to increase treatment options for life-threatening illnesses. Called accelerated approval, this process allows FDA to approve a drug on an expedited basis using promising but limited information about its safety and effectiveness, but only on the condition that the company agrees to conduct further studies to confirm

the safety and effectiveness of the product. Under the law, drug companies are required to do additional studies to confirm that the drug is safe, effective and works for its approved indication.

* The importance of conducting postmarketing studies to ensure the safety of drugs approved through accelerated approval is illustrated by the example of encainide and flecainide. In the 1980's encainide and flecainide were approved to treat ventricular arrhythmia after myocardial infarcation. Arrhythmias are a risk factor for heart attacks and encainide and flecainide are very good at suppressing arrhythmias. People assumed that because the drugs were good at suppressing arrhythmias, they would also prevent heart attacks. While this treatment was on the market between 250,000 and 500,000 people were prescribed the drug every year to prevent heart attacks. When the postmarketing clinical trial was conducted to confirm that encainide and flecainide did in fact reduce heart attacks, the study found these drugs actually tripled the rate of death. The drugs were withdrawn from the market. If the postmarketing study had never been completed, doctors would have continued to prescribe a drug that they thought was beneficial but was actually killing people.

* Postmarketing studies are also important to ensure that drugs approved through accelerated approval actually work. In May 2003, Iressa, which is manufactured by AstraZeneca, was approved under the accelerated approval process for treatment of non-small cell lung cancer in individuals who have failed to respond to two or more courses of chemotherapy. Iressa showed promise in early studies. The FDA approved Iressa, on the condition that AstraZeneca continue research on the drug to confirm the early results. Complying with the FDA's mandate, AstraZeneca conducted a postmarketing study and found that, for most people, Iressa was not effective. The drug was withdrawn from the market. This trial provided critical information to both physicians and patients who are trying to determine the best course of treatment for this horrible disease. If the postmarketing study had never been completed, doctors would have continued to prescribe it and patients would have continued to spend $1,800 a month for a drug that is ineffective for most patients when there are alternative treatments available.

* Unfortunately, many companies fail to conduct the postmarketing studies they promised to complete as a condition of approval on a timely basis and the public may go years without knowing whether the drugs approved through accelerated approval are really safe and effective. According to information provided by the FDA to my staff on March 30, 2005, drug companies take a very long time before they even initiate postmarketing studies that are required as a condition of approval as of March 9, 2005; companies with outstanding trials had been selling these products to the public for an average of 1 year and 10 months and up to 6 years and 9 months without even initiating the required studies.

* Despite the fact that companies often wait years before starting required postmarketing studies, the FDA has never used the only mechanism it has to enforce compliance with the requirement: withdrawal of the product. According to the HHS IG, ``Currently, short of withdrawing a drug from the market--a remedy available to FDA only in limited circumstances--the only short-term, practical options available to FDA in dealing with drug applicants that do not comply with the terms of their commitments are sending letters and placing phone calls. Providing FDA reviewers with additional tools, such as the ability to impose monetary fines, may send a signal to drug applicants that there are consequences when postmarketing study commitments are not fulfilled.'' The SAFE Drug Act will provide additional enforcement mechanisms.

* The system of tracking postmarket safety issues and monitoring and enforcing postmarketing studies is broken and failing to ensure patient safety. The SAFE Drug Act will address these problems by:

* (1) Providing the FDA with authority to require postmarketing studies and enforce the prompt completion of those studies;

* (2) Providing the FDA with mechanisms to help monitor the progress of postmarketing studies;

* (3) Providing the Secretary with the authority to require that the label include specific wording to ensure safe and effective use of a product including special labeling to help consumers identify accelerated approved drugs or biologics until converted to full approval;

* (4) Restricting direct to consumer advertising for accelerated approved drugs or biologics until converted to full approval;

* (5) Providing FDA employees with enhanced whistleblower protections if they are retaliated against for reporting violations of laws or regulations or a significant threat to public health and safety to Congress, GAO, Federal Agencies, or their bosses; and

* (6) Requires reports to Congress on the systems to track postmarketing safety issues and approvals that are based on Non-Inferiority Trials.

* According to a recent Wall Street Journal Online/Harris Interactive health-care poll, a majority of the American public is concerned about the FDA's ability to ensure the safety and efficacy of drugs. We need to stop the erosion of public confidence in the FDA, reform the system of postmarketing studies, and ensure that FDA balances the desire to speed drugs to market with its critical role as the watchdog of public health. I urge my colleagues to support the SAFE Drug Act.

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