Providing for Consideration of H.R. 5384, Agriculture, Rurual Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2007

PROVIDING FOR CONSIDERATION OF H.R. 5384, AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS ACT, 2007 -- (House of Representatives - May 23, 2006)

BREAK IN TRANSCRIPT

Ms. DeLAURO. Mr. Speaker, it has been a privilege to serve on this subcommittee and to work on issues of such importance, such as rural development, nutrition, drug safety and so many others, and I have enjoyed working with Chairman Bonilla in my time as ranking member.

We have produced a good bill I think, but I am disappointed that this rule does not allow for consideration of an amendment I planned to offer that would have increased funding for rural development and renewable energy programs by $500 million. Nor does this rule protect language giving the FDA, the Food and Drug Administration, the much-needed authority to mandate post-market drug studies when needed.

In offering this amendment, I believe we could have begun to meet a variety of rural development needs, from waste and water grants and community facility grants to funding for broadband expansion and renewable energy infrastructure.

In particular, we could have made a strong commitment to renewable energy by providing meaningful incentives for renewable energy production, consumption and infrastructure through programs in the farm bill and in the energy bill, the Bioenergy Program, the Value-Added Agricultural Product Market Development Grants, the Renewable Energy Systems and Energy Efficiency Improvements Programs, just to name a few.

But even though we have an extraordinary opportunity to reenergize our farm economy at the same time we jump start the country's energy independence efforts by getting these new technologies out of the labs, onto our roads and into our homes and businesses, our investment in these programs continues to be tentative.

Mr. Speaker, with Americans ready to declare their energy independence, with biofuels on the cusp of revolutionizing the American economy in the very near future, just as they did for Brazil in only a few years' time, we can make a statement that the Congress is ready to face this challenge. We should be tapping the promise that our farms hold to reduce our dependence on oil and provide a more secure economic future for our farmers.

I am also disappointed that the Rules Committee failed to protect language approved by the Appropriations Committee to give the Food and Drug Administration, the FDA, the much-needed authority to mandate post-market drug studies when needed and allow the FDA to begin the process of removing the drugs in question from the market if there are instances of noncompliance.

The amendment is simple. It would require anyone who has the approval of the FDA to sell a drug to conduct any study or studies on any significant safety issue on that product that the FDA requests.

This language addresses one of the key issues identified in the recent GAO study on post-market studies which concluded that, ``the FDA lacks clear and effective processes for making decisions about and providing management oversight of post-market safety issues.'' The FDA needs this authority to ensure that we are not putting lives at risk with unsafe drugs that are not fully tested.

Let me quote to you what the GAO study said: To improve the decision-making process for post-market drug safety, the Congress should consider expanding FDA's authority to require drug sponsors to conduct post-market studies, such as clinical trials and observation studies, as needed and to collect additional data on the drug safety concerns.

This is an issue that could not have come up at a more appropriate time. Just yesterday, the New York Times reported that the data analysis that was completed on Vioxx was done in a way that actually minimized the risks of the drug. That tells us that even when post-market studies are conducted, they cannot be counted on to be completely reliable. The language stripped by this rule would have constituted one small step toward implementing a better post-market system at the FDA and to stop putting at risk the lives of the American public and make sure that the drugs are safe and that they are fully tested and that, when we have adverse reactions to these drugs, that there is a way in which the government can, in fact, make sure that these companies do what is required to ensure public health.

So, Mr. Speaker, while I do believe we have produced a good bill, these are two areas in which I am very disappointed because I think we had an opportunity to produce an even better bill.

BREAK IN TRANSCRIPT

http://thomas.loc.gov/