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News Release

HHS IDENTIFIES DRUGS FOR PEDIATRIC TESTING
AND ANNOUNCES FY 2003 AND FY 2004 FUNDING

HHS Secretary Tommy G. Thompson today named 12 commonly-prescribed drugs that need to be tested for use in children. He said government-supported tests of the drugs will begin this year, with up to $25 million available to launch the tests in fiscal year 2003 and up to $50 million to be included in the President's FY 2004 budget proposal next month for the testing.

The testing is called for in the Best Pharmaceuticals for Children Act (BPCA), which was signed into law by President Bush last year. The law provides for HHS' National Institutes of Health (NIH) to sponsor pediatric tests of certain drugs already approved for marketing but either never tested or not fully tested specifically for their effects in children. The list released today identifies the dozen highest-priority drugs needing pediatric testing.

"Children often react differently to drugs than adults do," Secretary Thompson said. "The drugs we are naming today have long been approved for marketing and are often prescribed for children, yet they have either not been tested at all in children or have not been tested in all age groups of children where they are used. We need to conduct testing now to fully understand the effects of these medications in our children."

The list of drugs released today was developed by the National Institute of Child Health and Human Development (NICHD), part of NIH, in consultation with HHS' Food and Drug Administration (FDA) and experts in pediatric research. The list, to be updated each year, includes:

Azithromycin (An antibiotic used to treat many different types of infections).

Baclofen (A muscle relaxant used to treat the spasms/tightness of muscles in patients with cerebral palsy).

Bumetanide (A diuretic that causes the kidneys to get rid of excess water and salt from the body).

Dobutamine (A drug that stimulates the heart and is used in critically ill patients).

Dopamine (A drug that is used to treat shock in critically ill patients).

Furosemide (A diuretic that causes the kidneys to get rid of excess water and salt from the body).

Heparin (A drug used for the prevention and treatment of harmful clots in the blood vessels)

Lithium (A drug used for the treatment for bipolar disorder -- extreme mood changes from depression to mania).

Lorazepam (A drug used for the treatment for acute seizures and long-term sedation in the intensive care unit).

Rifampin (A drug used in combination with other medications to treat tuberculosis, and to treat carriers of certain meningitis-causing bacteria.)

Sodium Nitroprusside (A drug used to reduce blood pressure in critically ill patients).

Spironolactone (A drug used as part of a regimen to prevent loss of potassium).

Each drug will undergo testing that could last several months to several years, depending on the type of testing needed. This will be followed by evaluation of the test results by the FDA and sharing the results with the pediatric community so that doctors and parents can make better treatment decisions for children. NICHD will oversee the testing process, consulting closely with other NIH institutes and the FDA.

Following enactment of BPCA last January, NIH set aside $25 million to launch tests this year. In his budget proposal next month, President Bush will propose doubling this amount in FY 2004. Complementing NIH's testing effort, FDA will work with NIH, industry, and the pediatric community to determine the specific research needed to improve pediatric-prescribing information on both the drugs on today's list and others prescribed for children but needing further testing. FDA will spend a total of $6.6 million this year to fund its responsibilities under the BPCA. This spending will increase to $11.5 million in the President's budget proposal for FY 2004.

"We have acted to make funding available immediately to support these tests, and the President's budget will expand that support for 2004," Secretary Thompson said.

Most of these drugs are no longer under patent and therefore not the exclusive property of any single drug firm. For this reason, the BPCA provided for government sponsorship of these pediatric drug trials.

At the same time, for pediatric testing of new drugs, HHS is taking separate action. Secretary Thompson announced last month that the administration will seek new legislation from Congress to clearly establish FDA's authority to require pharmaceutical manufacturers to conduct appropriate pediatric clinical trials on new drugs and biologics. He said legislative authority would be pursued because it was quicker and more decisive than legal appeals. FDA earlier asserted its right to require such tests, but the U.S. District Court for the District of Columbia ruled against the agency last October.

In addition to requiring the NICHD and FDA to compile the list of drugs announced today, the Best Pharmaceuticals for Children Act reauthorized an existing economic incentive (extended protection from market competition) for pharmaceutical companies that conduct pediatric studies requested by FDA. However, this economic incentive only applies to certain drugs with existing patents or marketing exclusivity. For these drugs, this incentive has resulted in a significant increase in the number of pediatric studies performed and in important information to guide safer and more effective use of medicines in children.

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Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.

Last Revised: January 23, 2003