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Local families with HIV-infected youngsters were instrumental in convincing authorities to propose of a new rule that would provide sick kids access to the latest medicines.

This new proposal, submitted to the Federal Drug Administration (FDA) by Secretary of Health and Human Services Donna Shalala, would require new drugs, as well as many drugs already on the market, to be tested on youngsters at the same time they are tested on adults. These studies will determine at what dosage in in what type of formulation the drugs are effective for children.

The requirement could only be waived if the FDA believes the drug is likely to be unsafe or ineffective for children, pediatric studies are impossible or highly impractical, or reasonable efforts to develop the drug for kids have failed.

Pediatricians and other health care providers have found their hands tied for years when treating children with serious diseases, because an estimated 80 percent of the drugs approved for adult patients by the FDA have not been approved for children.

Speaking on behalf of the new FDA proposal, Shalala said, "Kids deserve the same access to newly developed drugs that their parents get. With this proposal we will have the power to ensure that pediatricians and other health care providers who treat children have the best scientific information available on which to base their medical decisions.

The new proposal is a victory for a group of northern California advocates for children with HIV/AIDS who mounted a campaign to force the FDA to require testing for kids. They specifically targeted the new AIDS drugs known as protease inhibitors, because none of them had been tested or approved for children.

While the FDA had been considering testing requirements for children for the past few years, what may have tipped the scales towards a serious proposal was personal appearances by members of this advocacy group, two Bay Area familes with HIV-infected youngsters.

Monte Rio resident Deb Sher and her eight-year-old son Dillon spoke before an FDA hearing on a new AIDS drug last November, and presented officials with a packet of information that explained how important it was to make all new drugs available for children whenever possible. Walnut Creek family Joan and Melissa Milne and brought the issue to the attention of President and Hilary Clinton when they met with them at the White House on several occasions.

The 90-day comment period on proposed new rule ends in mid-November, after which time the rule would go into affect if there are no serious objections or revisions.

In March, even without the new proposal in place, the FDA approved two protease inhibitors for children, Nelfinavir/Viracept from Agouron Pharmecuticals, and Ritonavir/Norvir, produced by Abbott Laboratories.

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