Last year, the U.S. Food and Drug administration kicked off the reauthorization process for MDUFA, or the Medical Device User Fee Act. The Act helps fund a significant amount of the FDA’s medical device regulatory review activities. In an announcement, FDA stated its intention to hold public meetings on the topic. The current legislative authority for the medical device user fee program expires in September 2017 and new legislation will be required for FDA to continue collecting user fees for the medical device program.
Reauthorization
FDA user fees began with the 1992 Prescription Drug User Fee Act, also known as PDUFA. This law led to the creation of user fee programs in other areas such as medical devices. In 2002, MDUFA was passed and then ultimately was reauthorized in both the 2007 FDA Amendments Act and 2012 FDA Safety and Innovation Act. The third iteration of MDUFA sought to improve review times for medical devices by increasing the funding for the FDA’s Center for Devices and Radiological Health (CDRH).
FDA’s speed in reviewing medical technologies will likely be a major concern for the reauthorization of MDUFA, which will now be the fourth version of the program (MDUFA IV). Additionally, reauthorization, as specified in the Federal Food, Drug, and Cosmetic Act requires the agency to seek public input before starting negotiations with industry.
Early Meetings
In September 2015, FDA held its first industry MDUFA IV reauthorization meeting. The discussion, as reported, revolved around introductory commentary and housekeeping issues. Ground rules were set that govern the negotiation process. FDA is said to have expressed a commitment to the goal of patient access to high-quality, safe, and effective medical devices; this, not surprisingly, was echoed by industry participants. A second meeting on October 1, 2015, included discussions on FDA’s response to industry data requests, which included an FDA presentation on the results of an analysis conducted on pre-submissions for IDEs. The agency announced its finding that IDEs with pre-submissions have a greater likelihood of first cycle approval. FDA also issued a summary of all relevant guidance documents that were issued during MDUFA III.
FDA also reviewed CDRH information systems for premarket reviews, explaining the data that is available and capabilities of the CDRH systems to support premarket reviews. FDA further explained CDRH’s implementation plans for the Center’s “Plan of Action” to address recommendations from previous MDUFA evaluations. Recommendations have included an assessment of quality management, an evaluation of review process, an evaluation of IT infrastructure and workload tools, an evaluation of training programs, and an assessment of staff turnover. FDA shared progress on each of the recommendations.
January 2016 meetings
As reported by Regulatory Focus, industry representatives and FDA met to continue MDUFA IV negotiations. FDA also issued a lengthy report on MDUFA III performance, including charts on CDRH’s work with PMAs, 510(k)s, and IDEs.
It was reported that FDA proposed the addition of 20 full-time employees, noting the lack of staff causes stress to the review system because staff time is divided among other activities. FDA also proposed shifting some compliance and surveillance activities along with the hiring if more staff. The agency additionally called for the use of “real-world evidence” in premarket decision-making. This would be done by building a structure that links and improves regulatory quality of data sources such as information obtained from electronic health records and registries. The agency also outlined ideas to strength its third party premarket review program, address digital health, IT modernization, and greater oversight of review procedures, to oversee appropriateness and quality of deficiencies, and to allow branch chiefs the time for increased interactions with industry, such as through longer pre-submission meetings.
Criticism of the process: how regulation kills medical innovation and hurts patients
In an interesting piece, Joseph Gulfo, the executive director of the Rothman Institute of Innovation and Entrepreneurship addresses Congressional oversight of FDA in light of the recent debate over now Commissioner Califf’s views on drug standards. Gulfo writes that FDA protects itself from attacks by doing four specific things: (1) raising the bar for product approvals by moving away from the statutory criteria of safety and effectiveness and demanding proof of clinical utility, clinical outcomes and survival; (2) demanding larger and larger trials that cost tremendous amounts of time and money; (3) shifting its emphasis to pre-approval requirements versus a balance of pre-approval data and post-market controls and surveillance; and (4) preferentially approving products for niche diseases rather than those that affect millions of Americans.
However, as Gulfo writes, after the agency responds to criticism with new rules and guidance documents, “Congress does not perform the appropriate police patrol oversight to re-direct the FDA back to its mandate, forcing the FDA to honor the letter and spirit of the laws that are passed. No, it does something worse: It actually passes more laws, for example, as part of each PDUFA (Prescription Drug User Fee Act) and MDUFA (Medical Device User Fee Act) reauthorization that takes place every five years, and in other legislation, like 21st Century Cures. This legislation, drafted in consultation with the FDA, then codifies the FDA’s new positions taken in response to inappropriate fire alarm oversight […] The vicious cycle starts over again the next time an unfortunate adverse events occur with drugs and devices that are on the market, which will invariably come to be. And this is how regulation kills medical innovation and hurts patients.”