DeLauro Statement at FDA Hearing
FOR IMMEDIATE RELEASE
Tuesday July 26, 2005
Statement of the Honorable Rosa L. DeLauro
WASHINGTON, D.C. - Congresswoman Rosa L. DeLauro (Conn.-3), ranking member of the House Appropriations Agriculture Subcommittee, delivered the following opening statement today during the subcommittee hearing on the Food and Drug Administration (FDA), where newly confirmed Commissioner Lester Crawford testified.
"Thank you Mr. Chairman. I know that we are both pleased to finally have the opportunity to explore so many important issues at FDA with Dr. Crawford. It is good to finally have you before this subcommittee, Commissioner - and we all wish you well in this capacity. This hearing is long overdue.
"As you know, Dr. Crawford, our counterparts in the Senate from both parties raised significant questions about the management of FDA prior to your confirmation during which time you were Acting Commissioner. You are, in fact, the first FDA Commissioner not to be confirmed unanimously. So, I know you understand that you and the agency will remain under close scrutiny from this subcommittee - we would be abdicating our oversight responsibilities otherwise.
"I think it is fair to say that FDA has not had a good year. In the space of 12 months, there have been flu vaccine shortages caused by inept oversight. There have been the delayed withdrawals of drugs such as Vioxx following thousands of deaths. There is a continuing failure to take regulatory action on an animal feed ban that could greatly strengthen the safeguards against the spread of brain-wasting diseases, such as mad cow disease, between animals. There were even attempts to discredit senior scientists with the courage to publicly reveal some of these critical lapses - these all occurred under your watch.
"I hope you would take the opportunity today to take responsibility for those problems - problems I want to explore in this hearing. I think we need to better understand what is happening under your management of this agency. FDA once enjoyed a reputation across the world of taking regulatory action based on the best science in the world. Now, it seems science takes a backseat to ideology and political interests. And believe me when I say that the confidence of the American people is at stake.
"And so, I want to examine your use of taxpayer dollars as you propose cuts to what your testimony calls your "greatest on-board asset," the staff of FDA, including your enforcement personnel.
"Mr. Chairman, I have quite a few questions today, and I hope that you will accommodate them. In addition to management problems, I am interested, for instance, in hearing what the Commissioner plans to do with the funding this subcommittee added to improve oversight of pharmaceutical direct to consumer advertising. Direct advertising is a relatively new practice, the cost of which has been steadily increasing in comparison to what the pharmaceutical industry spends on Research and Development. It requires close attention especially as these companies promote new drugs, but is only one of the critical areas of oversight FDA has over the drug industry. There are several other policy areas that I would like to explore, Mr. Chairman, including FDA's authority to negotiate label changes with pharmaceutical companies and the industry's lack of compliance with respect to post-market studies.
"And so, I look forward to hearing what is happening at FDA - what you as the Commissioner have done thus far to improve performance and what you intend to do in the near future. This is a matter of accountability to the Congress and the public.
"I am very concerned for the FDA, which is why I want you to succeed. If you use this opportunity to restore public confidence in the FDA, you will have no stronger supporter on this committee.
"Thank you."
http://www.house.gov/delauro/press/2005/July/FDA_statement_07_26_05.html