Several high-ranking officials with the US Food and Drug Administration (FDA) expressed confidence this week that they will meet all their obligations to industry under the medical device provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012.
Hamburg and Shuren: CDRH on Track
Speaking in Washington, DC at the Advamed conference on 25 September 2013, FDA commissioner Margaret Hamburg provided extensive remarks on the requirements and effects of the FDASIA legislation, which included a section known as the Medical Device User Fee Act that increased funding for FDA in return for new commitments for expedited review times.
"Under the law, FDA has promised to greatly enhance performance goals and other requirements for the device review process," Hamburg explained. And while those requirements are numerous-reports, guidance, regulations, public meetings and new strategies-FDA is helping the public and industry to keep it accountable by implementing a publicly available tracking system.
Better yet for industry: FDA seems to be on track to meet its FDASIA requirements for medical device-related activities.
"And as we approach the one-year anniversary of this law, I am pleased to say that we are making great progress in meeting these deadlines," Hamburg said. "Preliminary data indicate that FDA has the potential to meet all of its fiscal year 2013 performance goals."
"For instance, there were a total of 90 deliverable target dates, some statutorily set," Hamburg noted. "We've already completed 74, or 82%, of them."
Jeffery Shuren, director of the Center for Devices and Radiological Health (CDRH), mirrored Hamburg's remarks in a subsequent "Town Hall" meeting at the Advamed conference. Shuren said the FDASIA changes were "helping the review process."
"To date-and while it's still early on in the process-we are on track to either meet or exceed all of those [FDASIA] goals," he remarked. "I think that's an encouraging first start."
What MDUFA Brings to FDA and Industry
Both Hamburg and Shuren also elaborated on those successes in their respective remarks.
Hamburg, for example, argued the newest iteration of the MDUFA program will help to
ensure a consistent premarket review program for industry and help speed patient access to safe and effective products.
"As you know, CDRH has long been under-funded by comparison with other medical progress centers at FDA," Hamburg said. "With FDASIA, CDRH will see an increase of nearly $309 million over five years. Coming at a time of continuing budget constraint, this source of funding is essential to support and expand FDA's staff of experts who review the thousands of submissions we receive every year from industry, and to do so in a timely, thoughtful manner."
This will allow FDA to hire 200 full-time equivalents over the next five years, and has already resulted in a reduced backlog of 510(k) and premarket applications (32% and 39%, respectively) and a 37-day backlog of average approval days for premarket approvals. Shuren's speech later on in the conference reiterated these points as well.
"The new, high-level funding-which still places CDRH well below other FDA centers, which Jeffery Shuren always points out to me-will make a big difference in allowing us to speed the review process for medical devices," Hamburg said.
Shuren spoke more to the practical aspects of MDUFA in his remarks, saying that new statutes have permitted companies to bypass the former requirement to file a 510(k), even if they really wanted to utilize the de novo pathway but had no adequate predicate device to reference. Shuren said FDA has already seen about a 100% increase in the number of de novo filings, with about 31 direct filings already in 2013. Review times for these filings are also trending downward, he added.
Sequestration: A Painful Pill to Swallow
In her remarks, Hamburg also pointed to the effect of sequestration on user fee funding, noting that $85 million in sequestered funding was directly from user fees.
"Suffice it to say, these cuts limit the agency's ability to hire the needed levels, impair our ability to issue regulations and guidance, and make it more difficult for FDA to deliver on performance commitments to industry to speed the path to approval that so many products depend on," Hamburg remarked.
"Hopefully, Congress will decide not to extend the sequester for the 2014 budget year and will exempt FDA's user fees."
"I also, of course, am hoping that Congress can find a way to resolve the current budget impasse so that we actually have a budget for the coming fiscal year," Hamburg added. Failure of Congress to pass a budget by 1 October 2013 would cause many of the agency's staff-those deemed non-essential-to be furloughed.