In the routine course of business, the FDA will often approve a drug with the requirement that further testing must be done for safety with children. Without this testing, doctors have no guidance on dosage for age and weight groups, and parents have no assurance that the drug won’t interfere with a growth phase or have some other unanticipated effect. Some drugs that are very effective on adults turn out to be useless on children.
Despite these important reasons for testing drugs on children, some pharma companies don’t fulfill that requirement. The FDA has tried various policies to encourage pharma companies to comply. The FDA recognizes that it can be more difficult to recruit children into studies. In addition to a natural hesitation to take any risk with a child, there is also a smaller pool of candidates from which to recruit. The FDA has offered extended deadlines and support. Noncompliance is unacceptably high. Lynn Yao, MD, at the FDA notes in her excellent blog on this topic that presently 50% of drugs approved for use in adults and never tested in children are being prescribed for children. Do parents know this when the prescription is written?
Now the FDA is trying to shame pharma companies into doing what they are legally required to do. The FDA has started publicly posting letters of noncompliance that have been sent to pharma companies. Here is the page on the FDA’s website with the letters and the explanation.
The law that requires testing drugs for efficacy on children is called the Pediatric Research Equity Act. Congress enacted this law in 2003 and renewed it last year. Compliance from some pharma companies has helped: It used to be that 80% of the drugs that are used on children and were never tested on children and now the per cent has droped to 50.
The pharma companies that are not complying with the Act’s stipulations are breaking the law, but there doesn’t seem to be any real consequences for them. I am hoping the FDA will be more proactive and institute real consequences for noncompliance so we can feel that our children are protected from side effects of drugs that are not intended or well-suited for them.
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