HHS Identifies Drugs For Pediatric Testing and Announces $93 Million in FY 2003 and FY 2004 Funding

1/21/2003

From: HHS Press Office 202-690-6343

WASHINGTON, Jan. 21 -- 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. An additional $18 million will also be provided for review by the Food and Drug Administration (FDA).

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 agencies to sponsor pediatric tests of certain drugs already approved for marketing but never tested specifically for their effects in children. The list released today identifies the dozen highest-priority drugs needing pediatric review.

"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 only been tested in adults. We need to conduct testing now to fully understand the effects of these medications in children."

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

Once a drug has been approved for a particular use, physicians may prescribe it for other uses, as they deem necessary. Many commonly available drugs, although approved for use in adults, have never been tested specifically for use in children. The 12 drugs on the list are currently prescribed for children, but their safety and effectiveness has been established only in adults:

Azithromycin -- An antibiotic used to treat many different types of bacterial infection

Baclofen -- A muscle relaxant used to relieve the spasms, cramping, and tightness of muscles caused by medical problems such as multiple sclerosis or certain injuries to the spine.

Bumetanide -- Used to reduce the swelling and fluid retention caused by various medical problems, including heart or liver disease. It also is used to treat high blood pressure. It causes the kidneys to get rid of unneeded water and salt from the body into the urine.

Dobutamine -- A heart stimulating drug.

Dopamine -- Used to treat Parkinson's disease and Schizophrenia.

Furosemide -- Used to treat swelling and water retention.

Heparin -- Decrease the clotting ability of the blood and help prevent harmful clots from forming in the blood vessels

Lithium -- Treatment for bipolar disorder (extreme mood changes from depression or anger to elation).

Lorazepam -- Treatment for anxiety.

Rifampin -- Used in combination with other medications to treat tuberculosis, and to treat carriers of meningitis-causing bacteria.

Sodium Nitroprusside -- A treatment for high blood pressure.

Spironolactone -- A treatment for high blood pressure.

Each drug will undergo about two years of testing, followed by evaluation of test results by the FDA. 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. In addition, another $6.6 million is available for FDA support this year, increasing to $11.5 million in the President's FY 2004 budget. Requests for proposals to carry out the research will be developed immediately, and contracts will be awarded later this year.

"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.

These drugs are no longer under patent and therefore not the 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, 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 drugs with existing patents or exclusivity. For these drugs, this incentive has resulted in a significant increase in the number of pediatric studies performed.

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