For Immediate Release:

Thursday, March 28, 2002

For Immediate Release: March 28, 2002

(WASHINGTON, D.C.) – In a bipartisan response to the Bush administration's decision to stop requiring that pharmaceutical companies verify the safety of their drugs for children, 12 Senators today called on the Administration to explain its decision.

In a letter to HHS Secretary Tommy Thompson, the Senators "express[ed] serious concerns" with the administration's decision, and said the "Administration's action will diminish" efforts to ensure the safety of children's medicines.

On March 18, the Administration announced it would set aside a regulation that provides doctors and parents with better information when giving children medications, because many of them are only tested in adults.

Since the 1997 rule requiring pharmaceutical companies to test their products to determine their safety and efficacy for children, 400 pediatric drug studies have been undertaken, compared to only 11 studies in the 6 years prior to the rule.

Senator Murray was and early supporter and co-sponsor of the "Best Pharmaceuticals for Children Act," which further offered drug companies an incentive to test their drugs, by granting a six-month patent extension for tested drugs. This legislation offered a carrot to drugmakers, which had been combined with the "stick" of the FDA rule.

"Given this administration's record, the decision to roll back yet another public safety protection is not altogether surprising; but to abandon a child safety protection is shocking," said Murray. "For the administration to abandon this measure to protect the health of our children is beyond comprehension."

Thousands of parents give their children Ritalin every day, despite the fact that the drug has not met FDA standards for never been tested on young children.

The text of the letter 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