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April 12 — The FDA's breakthrough therapy designation has led to shorter drug development times and shorter FDA review times, industry experts said April 12 during a Senate briefing.
Enacted in July 2012 as part of the Food and Drug Administration Safety and Innovation Act (Pub. L. No. 112-144), the breakthrough therapy designation expedites the development and review of drugs for serious or life-threatening conditions if the drug has demonstrated substantial improvement on at least one clinically significant endpoint over available therapies.
Jeff Allen, executive director of the Friends of Cancer Research, said pre-market development times for drugs that have received the breakthrough designation have been slightly over two years faster than drugs that haven't received the designation. Allen also said the FDA review time for these drugs is three months shorter than for drugs without the designation. The Friends of Cancer Research, a think tank and advocacy organization, sponsored the briefing.
So far, the FDA has granted 115 breakthrough therapy designations and approved 40 breakthrough products, Allen said.
Mathias Hukkelhoven, senior vice president of global regulatory, safety and biometrics for Bristol-Myers Squibb, said “we need to focus on development time more than FDA review time” because “we've seen that FDA can act very quickly.”
“The real promise of the breakthrough therapy designation is in the development time,” Hukkelhoven said. The designation allows companies to discuss with the agency how new drugs should be developed so that companies can make the right decisions, he said.
Hukkelhoven also said it's important to have collaboration between the FDA's Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health because many of the breakthrough products are biologics that have a companion diagnostic.
Janet Woodcock, director of the CDER, said the FDA has a two-page template that companies can use to apply for the breakthrough therapy designation.
Woodcock said more people need to be engaged with clinical trials and everyone should be involved, including doctors. She said recruitment for clinical trials “is a huge barrier” and getting more people engaged in trials can improve outcomes and shorten drug development times.
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