Legislation to promote new neonatal drugs

Last Thursday, Graham’s Foundation put on a webinar about proposed legislation that would encourage drug companies to develop new treatments for preemies. The speakers explained that most new drugs are developed for adults, and then if they can be used for children, they are then reduced down to a pediatric form. The primary reason for this is money — adults with blood pressure issues far outnumber preemies in NICUs, and the production follows the demand.

One of the doctors explained that no new drug to treat preemies has been approved since 1999, and that was a surfactant. (And believe me, as the father of a 22 week, 6 day preemie who came out ok, I do appreciate that.)

The solution they’re proposing is to specifically stimulate the development of drugs for neonates. The incentive they want to offer the drug companies is an “exclusivity voucher” which, if a drug company developed a neonatal drug, would allow that company to have an extra year of patent protection on a different drug.

During the webinar, one of the doctors said that he would love it if there were a treatment that could be used to correct a preemie’s patent ductus arteriosis with the use of a catheter, rather than the other two scary options. Our son had a patent ductus arteriosis, and the doctor wanted to use indomethacin to close it. That drug has a tendency to shut down people’s kidneys when used, although it can close the PDA. When I heard that, I said to the doctor, “That sounds like you’re asking me not to breathe on Monday and it’ll be ok because I can breathe on Tuesday.” And then he told us about the other option of heart surgery that was almost sure to pinch a vocal cord in the process and could cause the baby to bleed to death quite quickly. And we immediately said yes to the indomethacin, which worked, thank God, but Gabriel does have minor kidney problems now, which might be linked to that treatment.

The name of this proposed legislation is the Promoting Life-Saving Therapies for Neonates Act, also known as Senate Bill 2041.

I learned a great deal in this webinar and am going to be exploring the issue further. I’ll probably come out in support of it and write the senators, but I am concerned about the unintended effects of government incentives on private industries. I used to work for Hanford Challenge, a watchdog organization that monitors a government nuclear waste treatment plant. The plant is half built, and has so many design flaws it is unlikely to treat the waste safely, but the contractor keeps getting oodles and oodles of government cash because they said they could do it. Would this proposed legislation actually spur development of much-needed drugs, or cause drug companies to do lip service to this to get the vouchers?

The Newborn Health Initiative Web site includes this picture of a preemie. Who looks huge to me. And where are the rest of the tubes and wires? (Our son was born at 22 weeks and 6 days.)

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