Gov’t advisor calls on FDA to boost clinical trials of drugs in kids

Posted under Blog, Companies, Diagnostics, Drug Safety, Funding, Institute of Medicine, Medical Devices, Medical Supply, pediatric drug development, Pharmaceuticals, Startups, Universities, Videos by Ryan McBride

U.S. regulators have overseen improvements in the way drugs are tested in children, but the FDA could do more to make pharma companies conduct safety tests on the long-term effects of meds in kids, according to a new Institutes of Medicine (IOM) report.

Done at the request of the FDA, the report highlights the importance of studying the safety and impact of drugs in children, whose developing systems can react differently to treatments than adults. The U.S. has made progress in studying the safety of meds in kids since two federal laws were passed that resulted in new requirements and incentives for drugmakers to carry out pediatric studies, MedPage Today reports.

"Still, studies involving children continue to be limited, especially in certain areas such as medications' use in newborns and long-term safety and effectiveness in children," the IOM said this week. The group has suggested that Congress and the FDA could turn up the pressure on companies to do "long-term pediatric studies of possible safety risks." It also recommended giving the FDA the flexibility to level sanctions "for unreasonably delayed studies."

- check out the IOM's release
- read more in MedPage Today's article
- find the full IOM report here

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PhRMA touts pediatric pipeline as it recruits lawmakers on legislation

Posted under Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, pediatric drug development, Pharmaceuticals, PhRMA, Startups, Universities, Videos by John Carroll

Lest anyone forget that biopharma companies are in the business of finding new treatments to help people, the industry group PhRMA regularly assesses the number of pipeline drugs in development by category. Now they've sized up the nearly 300 pediatric drugs which are in development specifically to help children and adolescents combat some terrible diseases.

The breakdown looks like this:

• 54 are for cancer
• 49 are for infectious diseases
• 48 are for genetic disorders (includes cystic fibrosis)
• 25 are for neurologic disorders (such as epilepsy)

PhRMA, of course, is also in the business of lobbying Congress on behalf of the industry. And this year their plan includes a big focus on the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA), which both expire in October.

"Reauthorization of these pivotal programs is essential to continued progress in children's health," says PhRMA CEO John Castellani. "Permanent reauthorization would provide much-needed predictability and certainty, to the benefit of regulators, innovative companies and, ultimately, children."

- here's the press release from PhRMA
- get the report (.pdf)

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