FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007 -- (House of Representatives - July 11, 2007)
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Mr. MARKEY. I thank the gentleman and congratulate the chairman, the gentleman from New Jersey (Mr. Pallone), for his enormously successful work; and Mr. Dingell as well, as well as the key Republicans who worked on this legislation.
I am pleased that the bill before the House includes language from the drug safety bill that Mr. Waxman and I introduced in March to strengthen the FDA's ability to monitor drugs after they have been approved and create a true post-market safety net system.
As we have seen with drugs such as Vioxx, new side effects and health risks may only surface after drugs are approved and are used by the general population. Yet the FDA has not had the authority to mandate label changes or require further studies to get more information about these risks once the drugs have been approved. This bill will empower the FDA with those important new authorities, and it will also establish a new post-market risk identification and analysis system to identify harmful side effects and uncover signals of unexpected adverse events without compromising patient privacy.
I am also pleased that the package includes a strong clinical trials registry and results database that is consistent with the bill that Mr. Waxman and I have been championing since 2004 when we learned that some drug companies were painting distorted pictures of their products by hiding negative trial results.
The current system, which allows companies to pick and choose which trials they want to make public, is like allowing students to just pick the grades they want to bring home. Everyone would have straight A's.
Our bill will establish one central mandatory registry of all clinical trials with strong enforcement mechanisms to require companies to make their clinical trials and the result of those trials available to the public, all of the trials. This is historic because the database of trial results will ensure that doctors and their patients have current, complete, and accurate information about all drugs on the market.
Finally, I want to thank Mr. Rogers from Michigan for working with me on the pediatric devices bill. It is an important bill that will help children get the devices that they need. I thank again Mr. Pallone, Mr. Dingell, and all the others who worked on this bill.
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