Loophole 1:
I am in Washington D.C advocating for Congress to pass the RACE for Children Act. I bet some of you are wondering what is the RACE Act, why is it important and why is the Swifty Foundation supporting it.
The RACE for Children Act is an update of the Pediatric Research Equity Act (PREA) which requires drug companies to develop their drugs not only for adults, but for children as well.
Today I thought I’d share some of the information we share with our congressional representatives and why the RACE Act is so desperately needed. There are two loopholes in PREA that we are addressing with the RACE Act. One of the two loopholes that we’re trying to fix in PREA is known as the orphan drug exemption. This exemption allows drug companies to receive a waiver for conducting PREA studies for an orphan drug. An orphan drug is a treatment developed for an orphan disease, which is a condition that affects less than 200,000 people in the United States. It doesn’t seem like this should apply to cancer, considering how unfortunately common it is in our society today. However, since cancers are so sub-classified, many very specific cancers are designated as orphan diseases. When they occur in children, drug companies do not have to test them as required by PREA. From our own research, we found that 90% of cancer drugs developed in the past 5 years have been designated as orphan drugs. That right there kicks out 90% of these possibly life-saving drugs from being tested on children. The RACE for Children Act would completely eliminate the orphan drug exemption so that cancer drugs could be studied in pediatric populations. It’s only fair, right?
