The FDA's proposed expedited access PMA (EAP) program should slash review time by about a third to around 12 months, the Evaluate Group predicts. Currently, the FDA takes an average of almost 19 months to review a PMA application.
Some products will benefit more than others, according to EP Vantage. Ear, nose and throat devices had an average review time of 8 months, compared to 46 months for wound management devices. And of course, only certain products will be accepted into the program--namely those intended to treat or diagnose a life-threatening or irreversibly debilitating disease, per the FDA's draft guidance.
Evaluate says the criteria are quite broad, but it remains to be seen whether the FDA will have the capacity to accept most of the applicants into the program.
A key feature of the program is reliance on postmarket trials as a means of speeding up commercialization. "Not only do you save time and money [through faster PMA review], you generate revenues which you would otherwise not have, and revenue generation can offset your burn on the product. Companies can sell the product and fund the rest of the trials from the market," Cenkos analyst Navid Malik told EP Vantage, noting that the FDA can pull products off the market if they perform poorly in the postmarket trials.
He compared the new PMA program to FDA's breakthrough therapy designation for biopharma candidates, which has been successful in bringing promising drugs to market faster.
Still, EAP didn't thrill device industry association AdvaMed, which pointed out that Congress called for the creation of an expedited pathway in 1997 and said the FDA "has not succeeded in meeting Congress's intent."
EAP is not in force yet. It was described in a recent draft guidance and will be implemented following a final guidance that takes into account stakeholders' comments on the draft version.
- read the EP Vantage article
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