Bipartisan House bill seeks to boost pediatric drug development via new FDA penalties for noncompliance

A bi­par­ti­san duo of law­mak­ers is seek­ing to boost pe­di­atric drug de­vel­op­ment with new leg­is­la­tion that would pri­or­i­tize adding pe­di­atric pa­tients to tri­als for new drugs.

The In­no­va­tion in Pe­di­atric Drugs Act of 2023, spear­head­ed by Reps. An­na Es­hoo (D-CA) and Michael Mc­Caul (R-TX) would tight­en re­quire­ments for drug de­vel­op­ment to be more in­clu­sive of pe­di­atric pop­u­la­tions.

Specif­i­cal­ly, the bill would re­quire that new drugs for rare dis­eases be test­ed in pe­di­atric pop­u­la­tions, and it would give the FDA the au­thor­i­ty to pe­nal­ize de­vel­op­ers for not com­plet­ing pe­di­atric stud­ies on time.

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