Murray Speaks Out on the Credibility Gap at the FDA

Sep 21 2005

Washington state’s senior senator calls for the FDA to return to the status of “gold standard” not “double standard”

(WASHINGTON, D.C.) – U.S. Senator Patty Murray (D-Wash.) a leading advocate for a strong, independent Food and Drug Administration, today took to the floor of the U.S. Senate to speak about the dangerous road down which Commissioner Lester Crawford has led the agency following the announcement of further delays on the application of Plan B.

Murray, who has repeatedly called for a yes or no answer from the agency on Plan B’s over-the-counter application, has filed several amendments to the Agriculture Appropriations bill in an attempt to force Commissioner Crawford to end the delays and return the FDA to a “gold standard.”

The full text of Senator Murray’s remarks follows:

Importance and Concern

M. President, I rise today to address a matter of extreme importance to women’s health, public safety, and the independence and credibility of one of our nation’s most revered federal agencies: the FDA.

M. President, I am outraged American women are outraged and consumers all across the United States should be outraged that the FDA is letting politics trump science in the way it approves medicines for the American consumer

Strong and Independent Agency

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.

By allowing politics to play a role in its decision making the FDA is opening a Pandora’s Box that could have profound consequences in determining the safety and efficacy on the drug approval process.

Plan B as Exhibit A

Unfortunately, recent decisions – and delays – at the FDA have 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 as 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, Wood said – and I quote -

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

M. President, these 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 of us in Congress who hadve 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.

What Is Plan B?

M. President, let me take a step back to 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 prevents pregnancy.

Emergency contraception cannot interrupt or disrupt an established pregnancy. In fact, Plan B has the potential to reduce the incidence of abortions – something we all can agree is an important goal.

Greater awareness and use of emergency contraceptives – like Plan B – is an important component to reducing the rate of abortion in the U.S.

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 is available over-the-counter in seven states – including my home state of Washington. But it is not available nationwide.

Why Plan B should be available OTC

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 locate 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 obtaining a prescription for emergency contraceptives including finding a pharmacy that stocks Plan B within the short timeframe. For many uninsured women and teens, the barriers are often insurmountable.

The “Hold”

In December of 2003 – almost two years ago – the FDA’s own scientific advisory board overwhelmingly recommended approval of Plan B’s OTC 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, told USA TODAY that:

“What’s disturbing is that the science was overwhelming 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 the 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 – Sen. Kennedy and Sen. 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 together to place a hold on Dr. Crawford’s nomination to head the FDA on June 15th, 2005.

We placed the hold saying we wanted a determination on the application – we did not advocate a particular outcome – all we asked for was that the FDA abide by its own rules and regulations.

This is a very important point, M. President. Senator Clinton and I did not demand approval. We were simply calling for the FDA to follow its own procedures.

In the end, apparently, that was asking too much.

The Double-Cross

The Administration and the Chairman of the HELP Committee understandably wanted Dr. Crawford confirmed. We began, what I considered to be a very productive conversation about restoring integrity to the FDA’s process and getting Dr. Crawford confirmed. I’d like to thank the Chairman for his responsiveness and good faith efforts.

Our discussions culminated in a July 13th letter to HELP Committee Chair and Co-Chair – Sens. Enzi and Kennedy – from Health and Human Services Secretary Michael Leavitt. This chart shows the letter from Secretary Leavitt. It says:

“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 assurance, Senator Clinton and I dropped our hold on Dr. Crawford and his nomination passed the full Senate.

Unfortunately for the American people and 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 this 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 this Administration give us their word that a decision would be made, and have that promise violated.

Now the FDA is claming that there are unanswered questions about Plan B’s effect on girls under 17. The fact is that the pending application does not apply to this group.

Today, girls under 17 may only receive this drug with a prescription and 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 like tobacco, nicotine gum and alcohol.

The Administration gave us their word, only to pull out the rug at the last moment. 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.

In fact, in his statement of further delay – Dr. Crawford acknowledged that the application has scientific merit, but still refused to approve it.

I can only infer that FDA – and Dr. Crawford as its head – are continuing to put politics beliefs ahead of science.

What Others Are Saying

And, I’m not the only one.

According to the Washington Post’s editorial page on August 30th:

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" and 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’s what Newsday said - quote:

Drugs and politics don't mix. The current case in point is Plan B, the morning- after emergency contraceptive, and the politics of abortion. Taken together they're 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 concern that younger teens would get the drug and wouldn't use it responsibly. That rings hollow. When the FDA rejected an application for over- the-counter sales without age restriction two years ago, it overruled its 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’s 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, the Baltimore Sun:

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

Gold Standard, Not Double Standard

No amount of semantics or politicking can change the fact that the HHS Secretary and the FDA performed a bait and switch with the United States Senate and – more importantly – to the American people.

Today, the Bush Administration has its FDA Commissioner, but the American public still doesn’t have an answer on Plan B. And – unfortunately – the FDA, which has long been known as the “gold standard” in drug approval, is at risk of becoming known for a double standard.

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.

M. President, as a new member of the Senate HELP Committee in 1997, I faced the daunting task of working to 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 was to 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 the drug review process.

M. President, the FDA has broken those lines of communications and has called into question the future of drug approval within the agency.

M. President I still believe in a strong and independent FDA, but I believe that this agency has made a mockery of Congress and of its own procedures and protocols. They have abused the trust of the Congress and of the American people in the way in which they have played around with Plan B. It is far past time to return credibility to the FDA.

M. President, 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.

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.