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Committee Takes Important Action on Drug Approval Process


Location: Washington, DC


Representative Edward J. Markey (D-MA), a senior member of the Energy and Commerce committee, delivered the following opening statement during the beginning of the Energy and Commerce mark-up of Food and Drug Administration reform legislation:

Mr. Chairman, I first would like to commend you for crafting such a strong legislation. I also would like to commend the Gentleman from New Jersey, Mr. Pallone - the Chairman of the Health Subcommittee - for his outstanding work on the bills we will consider today.

Today this Committee is taking important action to respond to the failures in the drug approval and post-market monitoring processes that have harmed consumers and undermined public confidence in the safety and effectiveness of prescription drugs.

VIOXX, Ketek, Avandia, Paxil - these drugs have harmed families across our country and come to symbolize the urgent need for reform. Families should never have to play "Rx Roulette" when they reach into their medicine cabinets.

Instead, this Committee is taking action today to address problems such as the inability of the FDA to require drugmakers to report all of their clinical trial information, the lack of FDA authority to require post-market studies, and the absence of strong FDA enforcement tools such as meaningful fines to encourage drugmaker compliance with FDA decisions.

I am pleased that one of the bills we will consider today will establish an online clinical trials registry database available to the public. This database will contain vital information for consumers, such as which drugs are the subject of clinical trials, where clinical trials are being conducted and how they can learn more about specific trials.

I also thank the Chairman for including such strong clinical trials provisions in today's reform package. These provisions are consistent with the drug safety and innovation bill - H.R. 1561 - that Congressman Waxman and I introduced in March of this year.

For parents desperately searching for a cure for their child, for a husband trying to find out more about experimental drugs that could save his spouse or for any consumer trying to learn more about emerging work on prescription drugs, the creation of this clinical trials results database is a significant new resource and a source of hope.

In addition to this registry, the clinical trials bill also establishes an online clinical trials results database accessible to the public. This results database will ensure that the findings produced from clinical trials are made public so that patients and their doctors have current, complete and accurate information about how drugs performed during the clinical trials and what effects they had on trial participants.

I also am pleased that we will consider legislation today that strengthens the FDA's ability to monitor drugs after they have been approved. As we've seen with drugs such as Vioxx and Avandia, new side effects and health risks may surface after drugs are approved and being used by the general population.

FDA has not had the authority to order a post-market study to follow-up on safety concerns and gather information needed to reassess the risks compared to the benefits of the drug.

I commend the chairman for strengthening the FDA's authority in this area- again reflecting the provisions in the drug safety legislation that Congressman Waxman and I introduced in March. Arming the FDA with this authority is a major step forward for all health care consumers.

By establishing a "Post-Market Risk Identification and Analysis System", today's legislation also appropriately recognizes the need for more information about drugs after they have been approved.

Section 5 of the legislation we are considering today relating to "Risk Evaluation and Mitigation Strategies" creates a new database to enable FDA to identify harmful side effects and uncover signals of unexpected adverse events and trends so that safety issues can be detected earlier than is possible today.

Clearly, this resource could provide important new benefits for the public health. It is also essential, as we authorize this new analysis system, that we protect patient privacy in the process.

I am pleased that Congressman Waxman and I, working together with our colleagues on the other side of the aisle, were able to develop a bi-partisan amendment that builds privacy safeguards into this system. We will be offering a bi-partisan amendment later today that supports this new system will also safeguarding patients personal information.

Finally, I want to commend the Chairman for his work on the pediatric devices bill and to recognize the efforts of my colleague on the Republican side - Mr. Rogers from Michigan - who has been my partner in the effort to improve the safety of medical devices for children.

Although children suffer from many of the same diseases as adults, children are not just small adults. In addition to size, children also have different rates of growth, physical activity levels and other differences - all of these factors affect their medical device needs.

Unfortunately, the development of new medical devices for children lags far behind that for adults, leaving doctors no choice but to "jerry-rig" adult devices for children.

The bi-partisan language that Congressman Rogers and I will offer to the Pediatric Devices bill later today makes important improvements in this area, and I look forward to continuing to work with Mr. Rogers and with Members on both sides of the aisle on this important issue.

Once again, I commend you, Mr. Dingell, and Mr. Pallone for your outstanding work on these bills, and I yield back the balance of my time.

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