Transcript of Congressman Hinchey's Remarks on House Floor - June 21, 2006

Mr. Speaker, I want to express my appreciation to my good friend and colleague from Texas, Mr. Gene Green, for providing me with this opportunity.

   As we have heard, Mr. Speaker, next week the Food and Drug Administration turns 100 years old, and it is unfortunate that this agency is not making laudatory headlines as it celebrates such an auspicious occasion.

   Instead, the Food and Drug Administration is at the nadir of its trustworthiness with the American people. Its basic defense of the public health has simply been perverted in the name of so-called conservative interests.

   As a member of the House Agriculture Appropriations Subcommittee which has oversight over the Food and Drug Administration, I have been frustrated by the agency's cozy relationship with the pharmaceutical industry whose products it is supposed to regulate.

   In 2001, fees paid by the drug companies funded 32 percent of the FDA's budget for drugs. Today, that figure is nearly 50 percent, and it is expected to go higher. Making matters worse, the FDA must negotiate with the drug industry on how those user fees are allocated. This financial dependency, along with the FDA's constant negotiations with companies over how to spend the fees, is the foundation for the conflict of interest that exists between the FDA and the pharmaceutical industry and others it is supposed to regulate.

   I have been alarmed that financial conflicts of interest are waived by the FDA among its advisory committee members. The agency relies heavily on these scientists and these experts to guide policy when questions arise concerning medical treatments. When the FDA allows conflicted scientists to serve on these boards, events that have occurred over 100 times already during this fiscal year alone, the public health is obviously jeopardized at the expense of inappropriate personal interests.

   I have been saddened by the stories I have heard from American families who have paid the price for mismanagement of this agency. I have met with many of these families on the efforts by the FDA to preempt their right to sue pharmaceutical companies in local and State courts. These families must be allowed to seek the understanding and justice they are owed after their loved ones are injured or killed from an adverse reaction to a product regulated by the FDA. I will meet with some of these families again later next week.

   For these and many other reasons, I and many of my Democratic colleagues have introduced legislation, the FDA Improvement Act and others, to address many of the loopholes that currently exist at this agency. This legislation would sever the financial links between the FDA and the drug companies. It would restore the independence of the FDA. It would strengthen the agency's efforts to guarantee post-market drug safety. It would eradicate conflicts of interest on FDA advisory boards. It would restore the public trust in this very critically important agency.

   Last month, the Wall Street Journal and Harris Interactive released a poll on public perceptions of the job that the FDA is doing on the safety of prescription drugs. Only 36 percent of the adults polled believe that the agency was doing a good job on ensuring the safety and efficacy on new prescription drugs. Eighty-two percent of the people polled believed that the FDA's decisions are influenced by politics over medical science to a great extent or at least to some extent.

   According to its own Web site, the FDA is our country's oldest consumer protection agency. It should be given the authority to do its job independently, and the administration should sufficiently use that authority to protect the American people. It is a two-step process.

   Yesterday, the American Association of Retired Persons reported that prices for brand-name pharmaceuticals jumped nearly 4 percent during the first 3 months of this year alone. The men and women paying for these drugs should be able to trust in the safety and the efficacy of the products for which they are paying so dearly.

   The Food and Drug Administration's 100th anniversary should be a time of celebration, and if we are going to make it such, we have to bring forward legislation to the floor of this House, legislation which makes the Food and Drug Administration free and independent, legislation which reestablishes the arm's-length relationship between the regulator and the regulated. That arm's-length relationship has completely disappeared because the FDA has become financially dependent upon the agency, the entities, the corporations, the drug companies that it is supposed to regulate, and that regulation has fallen apart.

   Let us bring forward legislation to the floor of this House which improves the FDA and protects the American people.