Mikulski Calls Head of FDA "Incompetent"; Expresses Concern Over Recent Issues

"The current administration has shown a persistent pattern of bringing in incompetent leaders into critical positions. We've seen it at FEMA. We've seen it at other agencies. And now it's true at FDA."

Senator Barbara A. Mikulski (D-Md.) called for a return to science in the Food and Drug Administration (FDA) on the Senate floor today, expressing her concern over recent issues at the agency. The Senator's statement comes in the wake of former Director Susan Wood's resignation from the organization.

The Senator's floor statement, as delivered, is below:

"I rise to encourage my colleagues to vote for the Appropriations bill that is before us. This is the Appropriations bill to fund Agriculture and the Food and Drug Administration (FDA). I would like to thank the Chairman of the Committee, the distinguished Senator from Utah, Mr. Bennett, as well as the Ranking Member on the excellent bill that they have put together, and therefore warrants our support because it does fund the agricultural needs of our community, but also funds the Food and Drug Administration.

"Madam President, Maryland is an agricultural state. It might surprise people because usually we're thought of as the home of high-tech research, Johns Hopkins University, the National Institutes of Health -but we are agriculture in soy beans and poultry. But also, we are the proud home of the Food and Drug Administration. We're so proud of the fact that the FDA is in Maryland and that that agency is charged with the mission of food safety and also with the safety of our drugs and our medical devices. One might ask, why is FDA in the AG Appropriations?

"Well, because its original mission was food safety. But now it has expanded to the mission of ensuring the safety of our drugs and also of our medical devices. It's wonderful to have them in this state. These competent people who work very hard putting America first, putting the safety first of our people, and also ensuring that drugs and medical devices move to the area of clinical practice.

"But I'm telling you Madam President, I am really worried about what's going on at FDA. FDA has always been the gold standard in maintaining drug safety and drug efficacy. Yet today, this agency is being politicized and degraded. The current administration has shown a persistent pattern of bringing in incompetent leaders into critical positions. We've seen it at FEMA. We've seen it at other agencies. And now it's true at FDA.

"And I am really worried that FDA is going to become the FEMA of drug safety, medical devices and also moving very important products to the community into clinical practice. I see appointments being made on the basis of ideology instead of competency. I see people who have worked and devoted their lives at FDA - 10, 15 or more years - resigning because they see science being politicized. I'm really worried about this.

"Now, I voted against the current FDA director, not because he is not a pleasant man, but because there were so many problems under his watch and they are not getting better. Let's take a situation that occurred on the consideration of something called Plan B. Now regardless of how you feel about whether Plan B should be available in the community, the fact is, I think we would all agree, that that decision, which is a really a kind of morning after pill, a form of contraception - yes, I understand it's controversial from a cultural standpoint - but the question is, was it controversial from a scientific standpoint? Well dilly dally, dilly dally, delay - even though the head of FDA promised Senators Clinton and Murray that it would be out. And guess what happened? What happened was, after the scientists made their decisions the director delayed it because he said, how can we prevent teenagers from getting it?

"Well Madam President, you're a mom. You know that if we can keep alcohol and cigarettes out of the hands of teenagers, surely the Food and Drug Administration would know how to handle this issue of contraceptives with teenagers. Put it behind the counter.

"But, what happened? Dr. Susan Wood, the director of the FDA Office of Women's Health, resigned in protest after 15 years of working at FDA. Dr. Wood is a distinguished scientist. She's a competent policymaker. She headed up the Office of Women's Health that the distinguished Senator from Maine, Senator Snowe, and I worked to establish to be sure that drugs and clinical devices went through the evaluation, special needs of women would be taken into consideration and also children, another aspect led by our colleague from Ohio, Senator DeWine. So, this is what Dr. Wood's job was. Guess why she quit? Did she quit because of pay? Did she quit because she got some big job with some pharmaceutical industry? She quit because she said this, 'After spending the last 15 years to ensure that science informs policy decisions, I can no longer serve when scientific and clinical evidence are being overruled by the leadership.' Well, she quit.

"So what happened? Again, at the Office of Women's Health, guess who they announced by e-mail on Friday? They announced a male - a guy - who spent the majority of his career in the Office of Veterinary Medicine. What a dismissive attitude of the Office of Women's Health. Now I'm not saying a man couldn't handle that job. He'd probably have to work twice as hard to prove himself, but nevertheless, a veterinarian in charge of the Office of Women's Health? I admire the veterinarian community. They play a very important role in our community. They are respected. They are admired. They have sophisticated training. But I don't believe, as we're looking at the impact of a drug on pregnancy or post-menopausal women, etc., etc., that a veterinarian should be the head.

"So, guess what? Advocates and scientists pound the table and FDA didn't even have the guts to stand up for its decision. It backed off, saying 'Oh, it never happened.' Well a lot of people have that e-mail, so they put someone else in charge. I don't know that person's qualifications, but we're not headed in a good direction. So I really want FDA to be the gold standard on safety and efficacy. There are many countries around the world that are poor. They rely on what is approved by FDA because they could never afford to have an FDA. Doctors in clinical practice rely on the FDA to tell them what is a good and safe drug or what is a good and safe medical device, or an effective device. This is phenomenal.

"I just had the benefit of this myself. I wore a heart monitor, invented in the United States of America that could tell my doctors whether the drugs they had given me controlled a condition for arythmia that I have. It was just wonderful to know that it had been approved by the FDA, that it could tell me if what I was doing was safe, and it could give advice to my physician on how best to treat me.

"This is what we want the FDA to be able to do. And the drugs that people take - are they safe? Well, we've got a lot of problems. And look at what has happened. We know what happened to Vioxx, out there prematurely, where data was withheld. We have all of these questions -you want to worry about teenagers - let's worry about antidepressants. I'm worried that they can get an antidepressant faster than they can get Plan B. That's up to parents and others to control, but these antidepressants have had a very negative and dangerous effect on some teenagers. Where was FDA?

"Now we have these implantable defibrillators that can go into your body - wonderful devices - that can jump start your heart. But, guess what? They're bound to have short circuits - the manufacturers knew about it. FDA knew about it. And they took no action on this.

"What has happened to our FDA? Well I have fought for the right resources, I have fought for the right legislative framework for FDA, and now I'm going to fight for the right leadership. I really wish Dr. Crawford would - number one, take charge of his agency. Number two, evaluate, I'm not calling for his resignation today, though he's got to think about what he's doing over there. We cannot continue to politicize this agency. And I'm just saying to him now that if he continues to politicize it, then we will have to look at further action.

"I believe he's a decent person, but either he's getting direction from somewhere else or he's lost direction, because this is meant to be a scientific agency - standing century over the safety of our food supply, monitoring to make sure and doing the evaluations whether a drug should come into clinical practice, whether a medical device can be safe and reliable and be the tool that it was, like I just had the benefit from.

"So I say now, let us support the appropriations. Let us make sure they have the right resources, but I sure as heck want them to have the right leadership, the right leadership so that we can come to the right conclusions and people all over the world, doctors, clinicians and so on, can rely on the FDA. And I'm going to rely on FDA for science and not politics."

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