[Congressional Record (Bound Edition), Volume 151 (2005), Part 15]
[Senate]
[Pages 20892-20894]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           AN INDEPENDENT FDA

  Mrs. MURRAY. Mr. President, I rise today to address a matter of 
extreme importance, women's health, public safety, and the independence 
and credibility of one of our Nation's most revered Federal agencies, 
the FDA.
  I am very concerned. American women are concerned, and consumers all 
across this country should be concerned that the FDA is letting 
politics trump science in the way it approves medicine for American 
consumers.
  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 when they walk into the local grocery store 
or local pharmacy that the products they purchase are safe, that they 
are effective, and that their approval has been based on sound science, 
not on political pressure or pandering to interest groups. By allowing 
politics to play a

[[Page 20893]]

role in the decisionmaking, the FDA is now opening a Pandora's box that 
could have profound consequences in determining the safety and efficacy 
of the drug approval process.
  Unfortunately, recent decisions and delays at the FDA have now called 
into question the agency's independence and allegiance to science-based 
decisions, and plan B is exhibit A. But don't take my word for it. 
Listen to Dr. Susan Wood, the former director of the FDA's Office of 
Women's Health. In resigning in protest, Dr. Wood wrote:

       I have spent the last 15 years working to ensure that 
     science informs good health policy decisions. I can no longer 
     serve a staff when scientific and clinical evidence fully 
     evaluated and recommended by the professional staff here has 
     been overruled.

  In later comments to the Associated Press she said:

       There's fairly widespread concern about FDA's credibility 
     among agency veterans as a result of the Plan B process.

  Those are the words of a health care professional who worked for 
years within the FDA to improve women's health. Her resignation is a 
huge loss to the agency, to those in Congress who have championed 
women's health and, most importantly, her resignation is a loss to the 
millions of American women who rely on the FDA to make choices based on 
sound science.
  Let me take a step back and explain what plan B is and why the FDA's 
actions are such a threat to the public's health. Plan B is a form of 
contraception. Plan B contains a specific concentrated dose of ordinary 
birth control pills that prevent pregnancy. Emergency contraception 
cannot interrupt or disrupt an established pregnancy. In fact, plan B 
has the potential to reduce the incidence of abortions, something I 
think every one of us can agree on. It is an important goal.
  Raising the awareness and use of emergency contraceptives such as 
plan B is an important component to reducing the rate of abortion in 
the United States. An analysis conducted by the Alan Guttmacher 
Institute estimates that 51,000 abortions were prevented by emergency 
contraceptive use in 2000 and that increased use of emergency 
contraceptives accounted for up to 43 percent of the total decline in 
abortion rates between 1994 and 2000. Plan B has already been approved 
by the FDA for prescription use and it is available over the counter in 
seven States, including my home State of Washington. However, it is not 
available nationwide.
  When it comes to emergency contraceptives, every hour counts. The 
effectiveness of plan B declines by 50 percent every 12 hours. The 
longer a woman must wait to see a doctor, get a prescription, and then 
find a pharmacy that will fill the prescription, the less effective 
plan B becomes. Even privately insured women with regular access to a 
health care provider have to overcome significant barriers to obtain a 
prescription for emergency contraceptives, including finding a pharmacy 
that stocks plan B within a short timeframe. For many uninsured women 
and teens, the barriers are often insurmountable.
  Back in December of 2003, almost 2 years ago, the FDA's own 
scientific advisory board overwhelmingly recommended approval of plan B 
over-the-counter application by a vote of 23 to 4. However, the FDA has 
not adhered to its own guidelines for drug approval and continues to 
drag its heels.
  In fact, Alastair Wood, who is a member of the advisory panel, told 
USA Today:

       What's disturbing is that the science was overwhelmingly 
     here, and the FDA is supposed to make decisions on science.

  At a HELP Committee hearing in April of this year, I pressed the 
President's nominee to head the FDA, Dr. Lester Crawford, to answer 
questions about this long-pending application for nationwide over-the-
counter approval of plan B. When Dr. Crawford informed me that he 
couldn't answer my questions in a public forum, I invited him to my 
office to discuss the process in a private meeting. My colleagues 
Senator Kennedy and Senator Clinton joined me for a very frustrating 
meeting in which Dr. Crawford failed to provide any timeline or 
specific reasons for the FDA's highly unusual foot dragging on the plan 
B application. It was very clear to me after this disappointing meeting 
that politics had trumped science, and the public health mission of the 
FDA had been compromised.
  For this reason, Senator Clinton and I joined to place a hold on Dr. 
Crawford's nomination to head the FDA on June 15, 2005. We placed that 
hold saying we want a determination on the application. We did not 
advocate for a particular outcome. All we asked was that the FDA abide 
by its own rules and regulations. That is a very important point. 
Senator Clinton and I did not demand approval. We simply called on the 
FDA to follow its own procedures. In the end, apparently, even that was 
asking too much.
  The administration and the chairman of the HELP Committee 
understandably wanted Dr. Crawford confirmed. We began what I consider 
to be a very productive conversation about restoring integrity to the 
FDA's process and getting Dr. Crawford confirmed. I thank the chairman 
for his responsiveness and good-faith efforts. Our discussions 
culminated in a July 13 letter to the HELP Committee and cochair, to 
Senator Enzi and to Senator Kennedy, from Health and Human Services 
Secretary Michael Leavitt.
  This chart shows the letter from Secretary Leavitt:

       I have spoken to the FDA, and based on the feedback I have 
     received, the FDA will act on this application by September 
     1, 2005.

  Based on this letter, based on his personal assurance, Senator 
Clinton and I then dropped our hold on Dr. Crawford and subsequently 
his nomination passed the Senate.
  Now, unfortunately for the American people and especially for the 
integrity of the FDA, Secretary Leavitt and the FDA broke their 
promise. The FDA had a chance to restore the confidence of American 
consumers in promoting safe and effective treatments, but it failed in 
its mission.
  A delay is not a decision. For over 6 months, Senator Clinton and I 
asked for a simple answer, yes or no. It is a breach of faith to have 
had this administration give us their word that a decision would be 
made and have that promise violated. Now the FDA is claiming there are 
``unanswered'' questions about plan B's effect on girls under 17. The 
fact is the pending application does not apply to that group. Today, 
girls under 17 may only receive this drug with a prescription. That 
would remain the case if the FDA were to approve plan B's application. 
The FDA's argument is highly suspect because the Government already 
regulates products with age restrictions. They do it with tobacco, 
nicotine gum, and alcohol.
  The administration gave us their word, and then they pulled the rug 
out at the last minute. This continued delay goes against everything 
the FDA's own advisory panel found nearly 2 years ago, that plan B is 
safe, it is effective, and it should be available over the counter. 
There is no credible scientific reason to continue to deny increased 
access to this safe health care option. In fact, in his statement of 
further delay, Dr. Crawford acknowledged that the application has 
scientific merit, but he still refused to approve it.
  I can only infer that the FDA and Dr. Crawford, as its head, are 
continuing to put politics ahead of science. I am not the only one. 
According to the Washington Post editorial page, August 30:

       In recent months, critics have accused the FDA--which is 
     required by law to make decisions exclusively on scientific 
     and legal grounds--of falling victim to outside political 
     agendas.
       They have claimed that the Plan B decisions have reflected 
     not sound science and legitimate caution but rather the 
     influence of ``moral'' antiabortion lobbies . . .
       By abruptly rejecting an application that had been tailored 
     to meet the FDA's requirements, Mr. Crawford appears to 
     confirm the critics' worst fears.
       Whatever the legal arguments taking place, this unexpected 
     delay at this stage of the approval process makes the FDA--
     long admired around the world for its neutrality and 
     professionalism--look like an easily manipulated political 
     tool.

  Here is what Newsday said:

       Drugs and politics do not mix.
       The current case in point is Plan B, the morning after 
     emergency contraceptive, and the politics of abortion.

[[Page 20894]]

       Taken together, they are threatening the Food and Drug 
     Administration's credibility as an agency that 
     dispassionately evaluates the safety and effectiveness of 
     drugs.
       The FDA said Friday it will delay for 60 days a decision on 
     whether to allow Plan B to be sold to those 16 and older 
     without a prescription.
       Officials attributed the foot-dragging to a concern that 
     younger teens would get the drugs and wouldn't use it 
     responsibly.
       That rings hollow.
       When the FDA rejected an application for over-the-counter 
     sales without age restriction 2 years ago it overruled that 
     staff and an advisory panel, and discounted the experience of 
     six states and 33 countries where such pills are sold without 
     prescription.
       The most recent application responsibly included the age 
     restriction.

  Here is how the Virginian Pilot put it:

       Plan B contraceptives can prevent tens of thousands of 
     abortions and unwanted pregnancies. Restriction on 
     availability to minors is consistent with other national 
     reproductive policies and therefore valid.
       A country that can put a man on the moon can surely figure 
     out how to distinguish between younger and older women in 
     selling a pill. If, that is, policymakers care half as much 
     about science in one case as in the other.

  And perhaps most succinctly, I quote from the Baltimore Sun:

       Dr. Crawford has been forced to adopt many improbable 
     positions in order to keep his job. But now he is at risk of 
     turning the world's most respected drug reviewing agency into 
     a laughingstock.
       Nobody wins if that happens.

  No amount of semantics or politicking can change the fact that the 
HHS Secretary and the FDA performed a bait and switch with the Senate 
and, more importantly, to the American people. Today, the Bush 
administration has its FDA Commissioner, but the American public still 
does not have an answer on plan B. Unfortunately, the FDA, which has 
long been known as the gold standard in drug approval, is now at risk 
of becoming known for a double standard.
  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. As a new member of the Senate 
HELP Committee back in 1997 I faced the daunting task of working to 
help reform the FDA. I, along with my colleagues, was dedicated to 
making the Food and Drug Modernization Act work.
  The intent of this landmark legislation was to introduce a new 
culture at the FDA, one which would expedite the drug approval process 
by eliminating unnecessary bureaucratic delays while ensuring product 
safety.
  This new partnership was intended to open the lines of communication 
and ensure that manufacturers had a clear understanding of what would 
be required in our drug approval process. The FDA has broken those 
lines of communication and has now called into question the future of 
drug approval within the agency.
  I believe strongly in a strong and independent FDA, but I believe 
this agency has made a mockery of Congress and of its own procedures 
and its own protocols. They have abused the trust of Congress and of 
the American people in the way they have played around with plan B. It 
is far past time to return credibility to the FDA. The FDA needs to 
return to the gold standard, not continue to create a double standard 
that puts politics ahead of the health and safety of the American 
public.
  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 this discussion about our priorities and our 
future is not lost.
  Mr. President, I yield the floor.
  The PRESIDING OFFICER. The Senator from Vermont is recognized.
  Mr. LEAHY. Mr. President, I ask unanimous consent that I may speak 
for up to 20 minutes.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. LEAHY. I thank the distinguished Presiding Officer.

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