Gregg Introduces Bill Requiring Stricter Testing of Pediatric Drugs
WASHINGTON—Senate colleagues and child health advocates praised New Hampshire Sen. Judd Gregg yesterday at a press conference called to announce the introduction of the Pediatric Drugs Research Authority bill. The legislation would allow the Food and Drug Administration to require pharmaceutical companies to conduct adequate clinical tests on how drugs can be used safely and affectively by children.
Sens. Hillary Rodham Clinton (D-N.Y.), Mike DeWine (R-Ohio) and Chris Dodd (D-Conn.) introduced the bipartisan legislation with Gregg, along with Sen. Edward Kennedy (D-Mass.) who did not attend the news conference.
“What this bill does is pull together language and gives authority to the FDA which will allow us to aggressively pursue procedures to improve the care of our children in America,” Gregg said.
The message stressed by each senator was that children are not just “small adults” and that smaller medication dosages are not always the most effective treatment. Only 25 percent of all drugs on the market have been tested for their effects on children, DeWine said, adding that pediatricians are forced to play “Russian roulette” when writing prescriptions.
Gregg, who is chairman of the Health, Education, Labor and Pensions Committee, received his biggest thanks from Bill and Susan Belfiore, who adopted four HIV-positive children from Romania in 1990. Ramona, 15, Ionel, 14, and Loredana and Mihaela, 13, all received tainted blood transfusions as babies.
Loredana and Mihaela are currently taking life-saving drug “cocktails,” which combine several drugs to combat the virus. If the girls receive too small a dosage of any one of the drugs, they will build up a resistance and the entire cocktail will be ineffective. Currently, there are only a few drug cocktails offered to treat the virus.
“As a parent, there is nothing more difficult than knowing your child is sick,” Belfiore said. “You feel scared, frustrated, terrified, helpless . . .. I can tell you that our family believes in miracles. But miracles won’t happen without the correct medication and the correct dosing, which can only be established through pediatric testing.”
The bill would give new life to a 1998 FDA rule that required pharmaceutical companies to conduct adequate research on drugs’ effects on children. Under the 1997 Better Pharmaceuticals for Children Act, the rule gave drug companies an extra six months of market exclusivity on every drug that they adequately test on children.
A federal judge struck down the rule last October, saying that Congress didn’t give the FDA the authority to issue such a mandate. A representative of one of the companies that brought the lawsuit questioned whether the proposed new mandate could slow the lengthy approval process for drugs for adults.
DeWine said the process would not be substantially slowed and reminded the representative that drug companies “are going to be well compensated for doing this.”
“I think it’s immoral to say that a drug company can test for adults and does not have to test for children,” DeWine said, as the Belfiores nodded in agreement. “What we’re saying in this bill is we’re no longer going to tolerate this.”
Spokespersons for the Elizabeth Glaser Pediatric AIDS Foundation and the American Academy of Pediatrics also spoke at the press conference. They praised Gregg’s strong leadership as committee chairman and said they hoped for full support from the House and Senate and expected President Bush to sign the legislation.
The committee is scheduled to consider the bill on Wednesday.
Published in The Manchester Union Leader, in New Hampshire.
