Statement of Senator Edwars M. Kennedy on Nomination of Dr. Lester Crawford for Commissioner of FDA

March 17, 2005

STATEMENT OF SENATOR EDWARD M. KENNEDY ON NOMINATION OF DR. LESTER CRAWFORD FOR COMMISSIONER OF FDA

Thank you, Mr. Chairman, and I commend you for calling this hearing on the nomination of Lester Crawford to be Commissioner of Food and Drugs. I welcome Dr. Crawford and I look forward to hearing about his plans for leading the agency in coming years.

I also want to welcome your lovely wife, Cathy Crawford. Won't you stand up so the committee can recognize you. Welcome to our committee -- and happy St. Patrick's Day.

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Effective leadership of FDA is essential to protect the health of all Americans. Friends and colleagues speak highly of Dr. Crawford's dedication and commitment to public service, but our committee has a special responsibility to make a careful evaluation of the qualifications of any nominee for this critical position.

As Acting Commissioner, Dr. Crawford has led FDA during troubled times. Serious side effects were belatedly discovered for several major drugs already on the market, raising alarming questions about the adequacy of FDA's review. There have been significant failures by FDA to disclose and manage conflicts of interest on scientific advisory panels. Over half the nation's flu vaccine was lost to contamination. Disturbing allegations have been raised that FDA has prevented open scientific discussion of important drug safety issues, has disregarded science that conflicts with ideology, and has retaliated against whistle blowers.

Just today, the New England Journal of Medicine published an article stating that at FDA there is "an atmosphere that stifles debate and discourages some employees from expressing scientific concerns about drugs."

It is essential to address these serious issues, and for Dr. Crawford to present a clear plan to restore the nation's trust in the ability of FDA to do its job.

FDA oversees about a quarter of all products purchased by America's consumers. Whether FDA does its job effectively can mean the difference between whether the infant formula you feed your child is safe or not, or whether the prescription drug you take does more good than harm.

Doubts have risen about the agency's effectiveness in the wake of Merck's withdrawal of its painkilling drug Vioxx from the market because of estimates that tens of thousands of patients may have suffered heart attack or stroke because of it.

Last October, we learned that half of last year's flu vaccine was lost because of poor manufacturing conditions at a plant in Britain. We were surprised to learn that FDA had not actively inspected the plant, and then compounded the problem by doing too little after it learned that some of the vaccine had been contaminated.

Last year the agency declined to approve emergency contraception for over-the-counter use after a nearly unanimous advisory committee recommended such approval. The agency is now two months late in ruling on a revised request for such use.

The agency has also prohibited or discouraged some of its medical officials from presenting their studies at advisory committee hearings, at scientific meetings, or in respected journals. The agency also chose not to disclose in advance potential conflicts of interest by members of the advisory committee who re-considered Vioxx and related drugs a few weeks ago, and approved their continuation on the market.

As the President's nominee, Dr. Crawford owes this Committee, the Senate, and the American people his assurance that, if the Senate confirms him as Commissioner, there will not be more of the same.

The stakes could not be higher. No patient who takes a pill should have to worry whether the drug inside is safe, or whether the decisions to approve the drug were based on politics or profits instead of science. It is a tragedy that FDA's recent failures have caused millions of patients to ask those questions now. It will be far worse if we don't insist on clearer answers.

These are large questions, and all of us look forward to Dr. Crawford's responses.

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