Food And Drug Administration Amendments Act Of 2007

Floor Speech

FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007 -- (House of Representatives - July 11, 2007)

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Mr. HINCHEY. Mr. Speaker, I very much appreciate the kindness of my friend and colleague from New Jersey for providing me with this time.

Mr. Speaker, I am a member of the Appropriations Committee and the subcommittee which has oversight over the Food and Drug Administration, so over the course of a number of years now, I have been deeply engaged in this issue.

I am glad that the FDA Amendments Act that we are discussing here this evening addresses a number of the problems that we have confronted over the course of the last number of years. These problems include giving the agency enhanced authority on post-market drug safety and developing a strengthened system for oversight of direct-to-consumer advertising. That is a very good move in the right direction.

However, I am deeply disappointed that this bill neglects to sufficiently address a number of other major issues that are jeopardizing the trustworthiness of the Food and Drug Administration, the agency that is supposed to represent the gold standard for consumer protection in America.

First, the FDA Amendments Act reauthorizes the Prescription Drug User Fee Act through which drug companies provide funding to the FDA for its drug safety approval and oversight activities. So, in other words, what we have is the regulated industry paying money to the agency that judges the worthiness of the industry's products and how they put those products on the market. To make matters worse, before each reauthorization of the Prescription Drug User Fee Act, the FDA sits down with representatives from this industry to negotiate out performance standards that the agency will achieve in return for those funds.

In fact, representatives from the FDA met 112 times with representatives from the big pharmaceutical industry before the agency sent their recommendations with regard to this bill to Capitol Hill. Meanwhile, the FDA only met five times with other groups, groups like consumers, medical professionals and advocates; only five times with groups like that to hear their perspective on reauthorization of the Prescription Drug User Fee Act.

The FDA is in bed with the drug companies, and put simply, the FDA Amendments Act does not sufficiently sever this inappropriate relationship between the agency and the regulated industry.

Under this bill, the FDA will continue to collect funding from a regulated industry and will continue to meet industry standards and put those standards above everyone else's interest.

Second, the FDA Amendment Act does not sufficiently address financial conflict of interest among members of agency advisory committees.

These committees exist to provide the agency with unbiased scientific advice on controversial issues, and such advice can easily be tainted by these conflicts; and we have seen numerous examples of how it has been.

Many of my colleagues will remember voting to end such conflicts during our consideration of the fiscal year 2006 Agricultural appropriations bill. Since that time, the FDA has come forward with a new policy of its own that would stop those members with over $5,000 worth of inappropriate financial holdings from even participating on advisory committees and stop all conflicted members from voting on the committees regardless of the size of that conflict.

Unfortunately, the FDA Amendment Act does not continue the movement for change that has been espoused by both the House and now internally by the FDA. Instead, this legislation would enable the agency to continue to waive conflicted members on to advisory committees. There is simply no need for this policy to continue.

Finally, this legislation does nothing to keep the FDA from its current misinformed policy of preempting State law on drug policy.

The Bush FDA's relentless arguments in favor of preemption robs consumers of recourse from injury and issues drug companies a free pass from accountability.

As we have seen from recent flu vaccine crises, revelations of conflicts of interest, and failures of post-market drugs such as Vioxx, the FDA is clearly not a perfect agency.

At the same time, drug companies are not sufficiently forthcoming about side effects related to their products. It is illogical for the Federal Government to close the door on a method of recourse for Americans who have been affected by these imperfections. In a world in which drug companies are not fully clear about the safety of their drugs, and the FDA is not sufficiently on the side of consumers, the role of the State courts in protecting Americans is more important than ever.

I am very disappointed in these provisions, and I think that they all should be considered carefully in the examination of this legislation.

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