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Public Statements

Food and Drug Administration Amendments Act of 2007

Floor Speech

Location: Washington, DC

FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007 -- (House of Representatives - September 19, 2007)


Mr. PALLONE. Thank you, Mr. Speaker, and I yield myself such time as I may consume.

Mr. Speaker, this is an important day for American consumers. Thanks to the legislation the House is about to pass, the Food and Drug Administration will have the financial resources and authorities necessary to ensure patients have timely access to safe and effective therapies.

First and foremost, this bill is about drug safety. In order to empower the FDA to protect the public from harmful drugs, we are giving the agency new authority to compel important labeling changes. This is a significant improvement over current policy, where FDA must haggle with drug companies and protracted negotiations that put patients and consumers at risk.

Under this bill, FDA will also be better equipped to force drug manufacturers to fulfill their responsibility to the American public and complete postmarket study commitments which are critical to ensuring a drug is safe.

In addition to these important new authorities, this bill authorizes the collection of $225 million in new user fees, a significant increase in the amount of funds dedicated for the use of drug safety activities.

The FDA Revitalization Act also provides for commonsense improvements to our Nation's food safety system, such as more stringent ingredient and labeling standards, establishment of an adulterated food registry, and improvements in public notifications.

Patients will be happy to know that the bill before us also requires greater transparency of drug makers by calling for clinical trials to be registered in a database monitored by the National Institutes of Health, along with basic results data. As we saw with the case of Avandia, making this information available to patients, providers and researchers is critical to uncovering potential harmful effects of a drug. And under this legislation, the public will also have greater access to internal documents that FDA used in its review of a drug application.

We also secure FDA scientists' right to publish by requiring the Secretary to establish clear policies on the timely clearance of articles written by FDA employees.

And finally, Mr. Speaker, this bill would make significant progress in reducing the number of conflicted experts who serve on advisory committees.

Mr. Speaker, I'm proud to say that this bill reauthorizes two very important programs for our Nation's children, the Best Pharmaceuticals for Children Act and the Pediatric Research and Equity Act. These programs have been crucial in the successful cultivation of important research used by doctors and parents to better determine what kinds of drug therapy is safest and most appropriate for a child patient.

In addition to the two existing programs, we're creating a new program that would help provide device manufacturers with greater incentives to conduct research and development of pediatric devices. Combined, these three bills will strengthen the research being done on pediatric uses of drugs and devices, and will make sure that our Nation's children have access to the medicines and therapies they need to grow up healthy and strong.

And finally, this bill reauthorizes two critically important user fee agreements with respect to prescription drugs and medical devices. These programs provide FDA with the necessary resources to review applications in a timely manner so patients who rely on new and improved drugs and devices don't have to go without. In addition to reauthorizing these existing user fee programs, this bill would establish a new user fee for the specific purpose of reviewing direct-to-consumer advertising.

I just want to commend Mr. Dingell, our ranking member Mr. Barton, Mr. Deal, and all of the members here, Mr. Waxman, Ms. Eshoo, Mr. Markey. Their leadership on these issues has been unwavering. It is to their credit that we have a bill on the floor today.

This is a great victory for American consumers that will make tremendous strides in empowering the FDA and restoring public confidence in its ability to protect the public health, and I would urge my colleagues to vigorously support it.

Mr. Speaker, I reserve the balance of my time.


Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I just want to thank everyone, particularly the staff that were involved in putting this legislation together and all the negotiations. I want to thank our legislative counsel, Warren Burke, Energy and Commerce Republicans, Ryan Long and Nandan Kenkeremath; Mr. Deal's staff, John Little; our Energy and Commerce Democrats, John Ford, Pete Goodloe, Virgil Miller, Bobby Clark; and Mr. Waxman's staff, Karen Nelson, Rachel Sher, Stephen Cha, Anne Witt; and also Mr. Markey's staffperson, Kate Bazinsky.

Needless to say, this bill is a product of a lot of hard work here in the House on both sides of the aisle, and, of course, we are also expecting, since this is going to be a consensus bill passed on the suspension list today, that it will pass easily in the Senate hopefully tonight or tomorrow. And it really addresses the problems and the safety issues that have come to light in the last few years.

I think many of us know there has been a lot of media attention to the fact that oftentimes drugs in the postmarketing situation have been problems. People have died. People have gotten sick. This bill I think effectively addresses those issues. I hope and expect that it will be noticed, because it will make a difference in people's lives.


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