| Comment Record|
Dr. Helen Johnston ||
2002-07-01 17:43:01 |
Highlands Pediatrics |
Health Professional |
| Comments for FDA General |
5. General Comments
The Pediatric Rule is a foundation for pediatric therapeutics. And the recently
passed Best Pharmaceuticals for Children Act (BPCA) moves children
further onto safer medical ground. They must BOTH be in place - the requirement
and the incentive - to ensure that therapies for children are not lost in a
legal or political quagmire.
The Pediatric Rule is essential for the following reasons:
The Pediatric Rule ensures that children are no longer a therapeutic afterthought
by the pharmaceutical industry. All new drugs must be studied for pediatric
use at the time a drug comes to market unless the FDA grants a waiver. This
puts children on a level playing field with adults for the first time.
The Pediatric Rule includes biological products. The BPCA provides incentives
to the pharmaceutical industry to study drugs but does not address biological
products. Significant portions of therapeutics used in children are biological
products. Without the Pediatric Rule there is no mechanism to ensure that
pediatric studies are conducted on these important medications.
The Pediatric Rule captures drugs and age populations that the Best Pharmaceuticals
for Children Act cannot. The BPCA incentive of additional market exclusivity
can only be applied once during the life cycle of a drug. When FDA requests
pediatric studies under BPCA, all potential pediatric uses must be anticipated
in the request. This request cannot be expanded later if additional studies
are needed in very young children or newborns or if a new use is discovered
for a drug. Once studies have been completed and the incentive has been granted,
there is no obligation on the part of participating companies to generate
additional pediatric data. The Pediatric Rule may be invoked in instances
where pediatric information is essential but the BPCA is no longer available.
The Pediatric Rule is ongoing the Best Pharmaceuticals for Children
Act is time-limited. The BPCA sunsets in 2007. If it is not renewed, history
suggests that the industry may not see it within their scope or financial
best interest to continue to do pediatric drug studies. The Pediatric Rule
will allow pediatric studies to continue.
The Pediatric Rule is mandatory the Best Pharmaceuticals for Children
Act is voluntary. Because BPCA is voluntary, not all sponsors are interested
in complying with the terms. The Pediatric Rule applies to all drugs and biologicals
whose intended use in pediatrics is the same as adults, thus ensuring appropriate