U.S. lawmakers eye incentives for kids' therapies

By Susan Heavey

WASHINGTON (Reuters) - Patent extensions for drug companies that test their medicines for use in children should be continued, U.S. lawmakers heard on Tuesday at a hearing that also considered incentives for devicemakers.

The provision, set to expire in September, allows pharmaceutical companies to receive a six-month patent extension in exchange for conducting clinical trials of their therapies for younger patients.

Such studies are key for doctors and parents to choose the best and most effective treatments for children. Without them, physicians must decide what therapy to use and how much based only on data gathered on adults.

At a hearing of the Senate Health, Education, Labor and Pensions Committee, medical and industry experts urged lawmakers to renew the practice of allowing drugmakers to hold exclusive rights longer in return for the information.

"Children's differing metabolism, growth and development, and size have very large effects," Dr. Richard Gorman said on behalf of the American Academy of Pediatrics, adding that nearly two-thirds of medicines used in children are not specifically labeled for them.

Gorman, a Maryland pediatrician, told lawmakers the system had generated "a flood" of new data that has helped doctors avoid potentially harmful side effects.

Still, some critics say the protection not only gives companies an unnecessary windfall but also impedes access by delaying the introduction of cheaper generic drugs.

Ohio Democrat Sen. Sherrod Brown said manufacturers instead should have to donate 10 percent of any profits from the 6-month exclusivity toward pediatric research or opt for three months of protection without any donation.

But Sen. Christopher Dodd, who chaired the hearing, said tinkering with the decade-old program could cause problems. The Connecticut Democrat added the current protection "seems to be working."

Dodd said his renewal plan would reign in excessive profits from the patent extension in the few cases where drugs earned more than $1 billion a year. He has already introduced another measure to encourage devicemakers to make products for children.

Industry representatives oppose any changes to the drug provisions, first passed into law in 1997. Instead, some companies want to see the current program made permanent.

Congressional reviews "remain major hindrances, discouraging companies from formally organizing pediatric infrastructures," Dr. Samuel Maldonado, head of Johnson and Johnson's Pediatric Drug Development Center of Excellence, said in his testimony.

Lawmakers at the hearing indicated they supported making permanent a separate plan giving the Food and Drug Administration power to require studies for children, but that market incentives should be reexamined regularly.

Similar measures are being considered in the U.S. House of Representatives, Dodd said.

The goal was for the Senate committee to move both proposals to the full Senate by mid-April for a vote, he added. Any differences in the Senate and House measures would have to be reconciled before they could be signed into law.