From The Editor | October 12, 2016

5 Important Changes Coming To The FDA

By Doug Roe, Chief Editor

FDA MDDS Compliance

Will new performance goals raise the bar at the FDA?

The U.S. Food and Drug Administration (FDA) has always had to balance the challenge of getting solutions to patients as soon as possible while simultaneously ensuring that those solutions are safe and effective. Historically, FDA’s execution of its duty has been marred by sluggish procedures, processes, and systems. Part of the reason for this inefficiency is the cultural precedence of the agency’s overly bureaucratic approach, as well as an obvious lack of the required resources. It was hoped that the 2002 introduction of the Medical Device User Fee Amendments (MDUFA) would improve the situation. Now that MDUFA is in its third iteration, having been renewed in 2007 and amended in 2012, progress is being made.

Where We Are So Far

Part of the MDUFA-driven reform is the requirement for FDA to provide Congress with an annual report of its performance. In the latest report, former FDA Commissioner Margaret Hamburg stated, “the medical device user fee program has helped expedite the availability of innovative new products to market by boosting the medical device regulatory review capacity through hiring new staff.” Most of the new resources (i.e., staff) were allocated toward improving submission review times, which “should meet or exceed all submission applicable performance goals for fiscal year 2014,” added Hamburg.

Other recent improvements to FDA processes include new guidance on pre-submissions, with clearer recommendations for device manufacturers, as well as timetables and the names of participants who will be involved in product review. Also, a new “accept or refuse” criterion was adopted for 510(k)s and premarket approvals (PMAs) lacking basic submission requirements, lifting the burden of additional FDA review. Additional improvements were the creation of an interactive review process to prevent delays through clearer communication between the agency and sponsors, and the installation of a third-party consultant to review the entire submission process, from systems and infrastructure, through reviewer training, workload, and turnover.

Where We Need To Go

With the good news comes some bad. The FDA still is not achieving its target “total time to final decision” goals…which brings us to MDUFA IV, the act’s 2017 reauthorization.  There are many changes in the latest update, but five stand out from the rest:

  1. Improvements in the pre-submission process — These improvements come from additional updates to the guidance, as well as the requirement for “meaningful” written feedback at least five days prior to any scheduled pre-submission meeting.
  2. First-time de novo product goals — 70 percent of all products (by the end of the agreement) must have submissions reviewed within 150 days.
  3. Increased patient experience during review — The use of patient preference information (PPI) and patient reported outcomes (PRO) will be incorporated to improve decisions on submissions and reviews. The FDA also will institute training in the proper use of PPI and PRO.
  4. Clarification on deficiency letters — Specific scientific rationale must be documented and included for all product rejection letters, allowing sponsors faster turn-around with targeted deficiencies.
  5. Improved total review time goalsThe goal for 510(k) total review time completion is a 108-day average. PMAs must reach the target of 290 days, a significant 25 percent improvement over the current average.

Four of these initiatives are being installed to speed overall product review times. The fifth — increased patient engagement — may initially slow the process, but once implemented it also should speed products through review, benefiting from the ever-expanding user data

Most of FDA’s senior leadership overseeing device regulation has been replaced since 2002, shifting an organization that was perceived as unresponsive and reclusive to one that strives to be interactive and front-facing. Much of this change has been led by Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH). 

MDUFA IV will provide Shuren and his teams with almost $1 billion for improvements over the next five years. “This draft agreement represents a substantial investment in the future of the agency’s medical device program. The funding will allow improved collection of real-world evidence from different sources across the medical device lifecycle, such as registries, electronic health records, and other digital sources,” stated Shuren.

What’s Missing?

While the new agreement looks promising, some items were not addressed, two of which stand out to device makers. First, questions exist about how the FDA will use/interpret its benefit-risk assessment, whose language has been deemed by some as too broad.

“With so few specifics, we are concerned that this document cannot be applied consistently within the FDA or throughout the industry. Effective guidance must be similarly interpreted by the majority of users,” commented the Advanced Medical Technology Association (AdvaMed) regarding the draft guidance.

 Also, the lack of clarity or supplementary guidance on combination products still is causing confusion and delays for products that could end up in any of the FDA’s three product review agencies. Removing these gray areas will help industry be better prepared as it approaches the review process.

MDUFA IV will be up for Congressional review in January 2017, and if passed will go into effect by the fourth quarter of next year. Improving the front-end of the process is a good start, but at the end of the day, only by reducing the total product review times will we accelerate the delivery of new, necessary products to waiting patients.