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  6. Transcript: Breakthrough Therapy (December 2015)
  1. FDA Drug Info Rounds Video

Transcript: Breakthrough Therapy (December 2015)

HOST: Captain Catherine Chew

Pharmacist: Lieutenant Zachary Oleszczuk

CAPT Chew: Speeding the development and availability of breakthrough therapies to treat serious diseases is in everyone's interest, especially when seeking advantages over existing treatments.

Hi, I’m Captain Catherine Chew and this is Drug Info Rounds, brought to you by the pharmacists in FDA’s Division of Drug Information.

In July of 2012, the Food and Drug Administration Safety and Innovation Act was passed which provided for the availability of a new designation for drugs known as Breakthrough Therapy. My colleague, Lieutenant Zachary Oleszczuk, is here with more information.

LT Oleszczuk: Breakthrough Therapy designation is a process designed to expedite the development and review of certain drugs that meet two statutory criteria. First, they must be intended to treat a serious condition. Second, preliminary clinical evidence must indicate that the drug may demonstrate substantial improvement over available therapies on at least one clinically significant endpoint.

CAPT Chew: The goal of breakthrough therapy designation is to get certain promising drugs developed and to market as quickly and safely as possible so they can be available to treat the patients who need them.

LT Oleszczuk: In general, we look for early signs that the new therapy offers a clear advantage over what is currently available for patients. If we grant breakthrough therapy designation to a drug, it means the drug is eligible for:

  • Intensive guidance on an efficient drug development program, beginning early in the process
  • Organizational commitment involving senior managers
  • Rolling review, and possible eligibility for priority review

We are here to assure pharmacists of one important aspect of all of FDA’s development and review programs and procedures - we always decide whether to approve a drug after evaluating whether its benefits outweigh its risks. Regardless of which development or review program we use, FDA does not compromise its safety or efficacy standards in exchange for rapid approval.  That means that those drugs approved under the new breakthrough designation will meet our usual rigorous standards for safety and effectiveness.

In 2013, we received 92 requests for Breakthrough Therapy designations. Over 96% of the goals associated with these requests were met on time or early by the FDA.

CAPT Chew: FDA intends to continue to maximize the value of our new breakthrough therapy designation, which is an exciting new program to expedite drug development. If you have questions about Breakthrough Therapy Designation,call or email FDA’s Division of Drug Information.

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