FDA Drug Info Rounds, July 2012: Accelerated Approval Program

FDA Drug Info Rounds, July 2012: Accelerated Approval Program


bjbj”9″9 7_tf Captain Mary Kremzner: When
it comes to treating serious or life-threatening diseases, speeding drug development and delivery
is in everyone’s interest. The Accelerated Approval Program is one way the FDA helps
make new, potentially lifesaving drugs available more quickly. Hi, I’m Captain Mary Kremzner
and this is Drug Info Rounds brought to you by the pharmacists in the FDA’s Division of
Drug Information. I’m joined by FDA pharmacist, Commander Catherine Chew, who will examine
the Accelerated Approval process and what it means for the medical community. Cat, can
you provide a little context about the origins and intentions of the program? Commander Catherine
Chew: Absolutely. When starting a new drug, Mary, as you know it can take a very long
time, oftentimes several years, to definitely demonstrate a clinical benefit and then go
through the process of securing FDA approval. In 1992 the FDA instituted its Accelerated
Approval Program as a way to speed new drugs to market that treat serious diseases and
fill an unmet medical need. Captain Mary Kremzner: Now Cat, exactly how does the FDA determine
when an expedited approval is warranted? Commander Catherine Chew: Generally drugs are approved
under Accelerated Approval if they have the potential to impact factors, things like survival,
day day function or the likelihood of stopping a disease from progressing and becoming an
even more serious condition. Captain Mary Kremzner: Now Cat earlier you mentioned filling
an unmet medical need. How would you define that? Commander Catherine Chew: An unmet medical
need simply means providing a therapy when none exists or providing a new therapy that
may be superior to or less toxic than an existing one. Captain Mary Kremzner: So without the
standard clinical outcomes how does FDA determine if a treatment is potentially effective? Commander
Catherine Chew: Great question Mary. Accelerated Approvals use what we call a surrogate end
point in clinical trials. These are markers or a physical sign of sorts used as an indirect
measurement to predict a clinically meaningful outcome like survival or symptom improvement.
Captain Mary Kremzner: So exactly how does the surrogate end point save time in the drug
approval process? Commander Catherine Chew: Well for example, instead of having to wait
to learn if a drug prolonged survival in cancer patients the FDA has approved drugs based
on evidence that they shrink tumors. As a surrogate end point, tumor shrinkage is reasonably
linked to real clinical benefit. Captain Mary Kremzner: Okay, so let me make sure I have
this. Let s say a drug goes through Accelerated Approval and gets to market, how do we know
if it really provides that clinical benefit? Commander Catherine Chew: Any approvals given
based on surrogate end points are on the condition that the sponsor will conduct post-marketing
clinical trials to verify the anticipated benefit. If these trials, called Phase 4 Confirmatory
Trials, shows the drug does in fact provide a clinical benefit then and only then does
the FDA grant traditional approval for that drug. Captain Mary Kremzner: Worst case scenario,
Cat, what if the drug fails to prove that clinical benefit? Commander Catherine Chew:
In that case the FDA has a series of regulatory procedures in place that could eventually
lead to the drug s removal from the market. Captain Mary Kremzner: The Accelerated Approval
Program strikes just the right balance between safety and speed which can make all the difference
to patients with serious or life-threatening diseases. If you have questions about the
Accelerated Approval Program, call or email the FDA s Division of Drug Information. SpeakWrite
www.speak-write.com Job Number: 12198-001 Custom Filename: FDA_DDI_Accelerated Approval_WM9_FINAL
Date: 07/16/2012 Billed Word Count: 586 h”#v h3X0 h”#v gd P 120716_141520_OT 21954d15-26ae-4b0b-8026-cca32ea08ad2
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