News Releases

(WASHINGTON, D.C.) Bowing to Congressional pressure, the Bush administration has reversed its earlier decision to suspend an FDA regulation that required drugmakers to test their products to determine whether they are safe and effective for children.

Sen. Murray, who had been a vocal critic of the Administration's plans to abandon pediatric testing, released the following statement:

"I am pleased that the Administration has acknowledged the grave mistake it made in trying to suspend pediatric drug testing. Many of us who care about consumer protection – especially children's protection – were shocked and angered by the Administration's initial decision.

It does not take a neurosurgeon to appreciate that children's bodies are different than adults and they may react differently to some medications. It is therefore entirely appropriate that the pharmaceutical companies should take every precaution to ensure the safety of their drugs for children.

In 1997, I was an early supporter and co-sponsor of the 'Best Pharmaceuticals for Children Act,' which encouraged drug manufacturers to test pediatric medicines. This legislation, in concert with the FDA's pediatric testing rule, resulted in many more medicines being tested.

But when I learned of the Administration's plans to abandon the rule, I was furious. With eleven of my colleagues, I sent a bipartisan letter to the Administration asking them to reverse their decision.

I am gratified that the Administration has heeded our call, and hope that in the future, President Bush will think twice before repealing other consumer protections. I will continue to work with my colleagues in the Senate on legislation to ensure that pediatric testing cannot be weakened through future administration actions."

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A copy of the bipartisan letter to the Administration follows:

March 26, 2002



The Honorable Tommy Thompson
Secretary
Department of Health and Human Services
200 Independence Ave., SW
Washington DC 20201

Dear Secretary Thompson:

We are writing to express our serious concerns with the Administration's announced intention to stay the Pediatric Rule for two years and would request a briefing as soon as possible to discuss the Administration position. As original cosponsors and supporters of the Best Pharmaceuticals for Children Act (BPCA), we believe very strongly that the legislation, which provides for market exclusivity incentives to drug manufacturers to test and label their products for safety and efficacy in children, and the regulation, which requires that certain drugs and biologics be studied for children, work as complements to one another in an effort to get all vital products tested for kids.

The BPCA, which was enacted in 1997 and reauthorized last year, has been very successful in increasing the number of products studied and labeled for children. In addition, last year's reauthorization includes a new mechanism to refer products that are not being studied voluntarily to an NIH fund so that studies may be conducted using private contributions or federal dollars. It is congressional intent that we not leave any important medicines, age groups, or indications unstudied. Our efforts through the BPCA in conjunction with the requirement established through the Pediatric Rule will serve to ensure that goal. In addition, the Pediatric Rule would also capture a class of products, specifically biologics, for which market exclusivity incentives do not apply and the Rule could be used to secure testing for very young children or neonates who may not be captured through the testing incentives.

During reauthorization of the pediatric testing incentives program this past year, our intent was not to replace existing mechanisms for ensuring pediatric testing, but rather to extend and build upon a program that has been working. The Administration's action will diminish rather than supplement that effort.

Taking any tool to achieve pediatric testing off the table is contrary to the overarching goal of ensuring that medicines are safe and available for our children.

We look forward to hearing from you soon.

Sincerely,

CHRISTOPHER J. DODD, MIKE DEWINE, EDWARD M. KENNEDY, PATTY MURRAY, JAMES M. JEFFORDS, TOM HARKIN, JEFF BINGAMAN, JACK REED, HILLARY RODHAM CLINTON, BARBARA A. MIKULSKI, PAUL WELLSTONE, JOHN EDWARDS