The FDA is showing improved performance and has met regulatory decision-making goals set during the 1st half of the user fee program established in 2012, an AdvaMed executive said today during a conference call.
AdvaMed’s senior executive veep of technology & regulatory affairs Janet Trunzo spoke during a call today discussing the trade associations concerns and perspectives on the FDA’s performance and its user fee program.
The call was in preparation for an FDA public meeting to discuss the user fee program set for July 13, as the user fee program is slated to expire in 2017. During the call, Trunzo praised a boost in review speed from the FDA in 510(k) submissions as well as increased transparency and connectedness from the agency, but said there was still room for improvement.
The agency’s review time for 510(k) clearance submissions has improved, Trunzo said, dropping roughly 16% since 2010.
“For the submissions that were part of the fiscal year 2013, the 1st year of the program, the average total time to decision was 128 days. That is down from the high of 154 days in fiscal year 2010 submissions. It is still too early to draw any conclusions on the FY 2014 cohort, as there are hundreds of 510k submissions that have yet to have a decision,” Trunzo said.
The picture for PMAs is less clear, Trunzo added, due to several PMAs from the 2013 fiscal year that have yet to be completed, and a wealth from 2014 that are being processed.
Trunzo said that AdvaMed had noticed a spike in the number of PMA submissions that were slated for panel reviews in 2013, up from the historic average. After advising the FDA on this issue, Trunzo said the agency issued guidance on streamlining these panel procedures and is expected to release more guidance on when an advisory committee is needed.
Trunzo said that so far, the rate of panel submissions has dropped for the fiscal year 2014, but that too many decisions were outstanding for that to be conclusive.
The FDA’s increased transparency and contact with the industry also got praise from Trunzo. “They’ve shown a true willingness to work with the industry, and we appreciate it,” Trunzo said.
There was still room to improve for the agency, Trunzo said, stating that while review times had dropped for 510(k)s from their historic highs, they were still very close to numbers from 2002, when the first user fee agreement passed. The speed of PMAs has also stayed similar to the 2002, Trunzo added.
Trunzo said that this varying time frame could be reviewer dependent, and said the FDA was taking steps to address this through better training and follow-up with reviewers.
Also ripe for review was the agency’s review process for combination drug-device products, Trunzo said. She said that a lack of standards for determining which FDA centers would have primary responsibility for reviewing such products was affecting the efficiency of such reviews, but that the FDA was aware of the issue and would be receptive to discuss it at the meeting.
“We know this is an issue the FDA is keen on working on so I anticipate we will have some fruitful conversations on this topic,” Trunzo said.
Trunzo said that all-in-all, the agency was doing well, and thought future negotiations would only strengthen its improvement.
“The bottom line is that we share a common goal with the FDA to ensure that safe, effective devices are available to patients in a timely manner, and furthering that shared common goal will be a foundation for the user fee negotiations,” Trunzo said.
