(WASHINGTON, D.C.) – U.S. Senator Patty Murray (D-Wash.) a champion for a strong and independent FDA, today introduced an amendment to the Labor, Health and Human Services (LHHS) Appropriations bill that would help support an investigation into possible mismanagement at the Food and Drug Administration.
Senator Murray’s amendment, H.R. 3010, would shift $3 million from the Office of the Secretary of Health and Human Services (HHS) to the Office of the Inspector General at HHS in order to conduct an investigation into potential mismanagement at the FDA
Senator Murray’s remarks on her amendment H.R. 3010 follow:
“M. President I rise this evening to offer an amendment that should not need to be offered.
In fact, each time I come to the floor to talk about Plan B and the FDA, I hope that it will be the last time. I continue to hope that the FDA or HHS will just do the right thing and finally put science, safety and efficacy over politics.
Unfortunately, M. President, over the course of the past several years, I – along with millions of Americans – have been disappointed time and time again.
M. President, I have always supported a strong and independent Food and Drug Administration. It is the only way in which the FDA can truly operate effectively and with the confidence of American consumers and health care providers.
Americans must have faith that when they walk into their local grocery store or pharmacy that the products they purchase are safe and effective and that their approval has been based on sound science – not political pressure or pandering to interest groups.
And that is why the application process for Plan B emergency contraceptives has been so troubling.
Back in December of 2003 – almost two years ago – the FDA’s own scientific advisory board overwhelmingly recommended approval of Plan B’s over-the-counter application by a vote of 23-4, but the FDA has not adhered to its own guidelines for drug approval and continues to drag its heels.
In fact, Alastair Wood, a member of the advisory panel, said that:
“What’s disturbing is that the science was overwhelming here, and the FDA is supposed to make decisions on science.”
M. President, it is obvious to me – to many of my colleagues – and to millions of American women – that something other than science is going on at the FDA.
And, M. President, it is far past time to get to the bottom if it.
That is why I am offering this amendment tonight to shift $3 million from the Office of the Secretary to the Office of the Inspector General at the Department of Health and Human Services. This funding will help the Inspector General’s office to investigate potential mismanagement at the FDA.
This investigation will be separate from ongoing investigations of the former Commissioner – Lester Crawford – and will include, but not be limited to, the over-the-counter application for Plan B.
M. President, let me be clear, the men and women of the FDA work hard. They adhere to the principles of science. They do a job that all Americans can be proud of.
But, M. President, their hard work is being undermined and overshadowed by the Agency’s own leadership.
If the leadership at the FDA and HHS refuses to take steps to restore the confidence of American consumers in the FDA’s ability to promote safe and effective treatments, then Congress must step in.
M. President, the health and well being of the American people should not blow with the political winds.
Caring for our residents is an American issue and part of that goal is ensuring that our residents have access to safe, effective medicines in a timely fashion.
Time and time again, I – along with my colleague Senator Clinton of NY – and others – have asked for a decision on Plan B. We have not dictated that we want a “yes” or a “no” – just that we want a decision. This continued foot-dragging is unusual, unwarranted and unprofessional.
This continued delay goes against everything the FDA’s own advisory panel found nearly two years ago, that Plan B is safe and effective and should be available over the counter.
There is no credible scientific reason to continue to deny increased access to this safe health care option – but there is even less reason to deny an answer.
M. President this is not the last word on this issue. The problem with politics subverting the FDA’s adherence to science and its integrity is so profound and so urgent that I intend to use every tool available to me as a Senator to make sure that this discussion about our priorities and our future is not lost.”
Read the text of the amendment
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