FDA Reforms Should Leave No Child Behind

Being in D.C. politics for years, I'm sensitive to the fact that making laws requires compromise.

Recently, Congress passed legislation of historic proportions -- novel drug safety reforms, new incentives for the development of pediatric medical devices, and improved drug testing protections for children, were all significant achievements. And while the legislation will provide children across the U.S. the ability to access safer medicines, it fails to give children a permanent guarantee that medicines be studied for pediatric use. Unfortunately, this means that every few years children again will have to fight for their right to safe and effective medications, a protection guaranteed permanently to adults.

We should all be deeply disappointed that Congress did not correct this important gap in drug safety law.

Making medicines for children requires special action. It is not just about taking an adult-sized pill and cutting it in half for kids. Pediatric formulations must be designed based on children's weight, physical activity, metabolism, and many other factors, all of which are very different and more specialized than adults. That's why it is critically important that drug companies design and test their medicines specifically for children's use.

As the U.S. takes this historic step in expanding drug safety for all, I hope that we may improve our efforts for children in years to come and finally recognize that the health of children is at least of equal importance as the health of adults.

Diane Thompson is vice president for public policy and communications at the Elizabeth Glaser Pediatric AIDS Foundation. Prior to joining the Foundation, Diane held executive positions in the private sector and the government, including service at both the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency. She has been a partner at both public policy consulting and law firms, and an adjunct professor at Hastings Law School.

Comments

[usna73]

Thank you for highlighting this very important distinction. Had this been the case for the past several decades, my son would not be totally mentally disabled as a result of merury poisoning.

Thimerosal used in childhood vaccines resulted in our child getting the maximum amount of mercury injected into his body over the course of his immunization schedule, since he had injections from multi-dose vials, where Thimerosal was used as a preservative.

Regardless of the debate in and out of science as to the absolute sets of etiology about Thimerosal and autism, there is no doubt in my mind that my son is mercury poisoned. Had Thimerosal been adequately studied by the FDA ( it was never done so because it was grandafthered into existence before the FDA was formed), this tragedy would not have occured.

The FDA is no longer a protective agency in any event. It is a revolving door for Big Pharma and reflects the deterioration of our culture and respect for life over profits.

[mrcontinental]

Don't forget Big Agro and their "genetically enhanced" foods which have been banned in most other western countries due to lack of testing results on humans.