Pediatric drug rule reinstated

The Pediatric Research Equity Act of 2003, which requires drug companies to test their products for use in children, has passed the House of Representatives and Senate overwhelmingly and is expected to be signed into law.

The legislation restores the protections of the Food and Drug Administration’s 1998 Pediatric Rule, which a federal district court invalidated in October 2002.

“This law will finally guarantee children the same access to safe and effective medicines that we demand for ourselves as adults,” said Mark Isaac, vice president of the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF).

About three-quarters of drugs used by children have not been tested for their use despite the fact that their small bodies metabolize drugs differently than adults, according to the foundation. In some cases, children have died or been seriously injured after taking drugs that were safe for adults but not tested specifically for use in children. Children are often overdosed or underdosed, resulting in drug resistance, adverse side effects, longer illnesses, and higher costs to the health care system.

The Pediatric Research Equity Act requires manufacturers to test the safety and dosing of all new medicines and some already marketed medicines for children. It will also ensure that drugs are available in forms young children can readily use, such as liquids and chewable tablets.

While applauding Congress for passing this legislation, the foundation continues to oppose the “sunset” clause in the bill, which allows its fundamental safeguards to expire in four years.

For more information on EGPAF, go to their website (www.pedaids.org).

The author can be reached at crummel@pww.org.