FDA Continues Push Toward Efficiency and Transparency

The winds of change are still blowing at FDA in 2012. The year has seen not only an extension of efforts to reform and improve FDA but also new policies and regulations that will affect FDA procedure. July 2012 saw President Obama sign the Food and Drug Administration Safety and Innovation Act (FDASIA) into law. FDASIA’s overall goal is to improve FDA and industry partnership. Key provisions include an expedited supervisory review appeal process, allowing FDA to reclassify devices by administrative order rather than regulation, and adjustment to the Sentinel program, which will allow FDA to use commercial and insurance data to monitor devices on the market. Most prominent, however, is FDASIA’s increase in user fees. Under the new act user fees will increase to $609 million in 2013-2017, up from their current level of $277 million from 2008–2012. The aim is to assist FDA with additional funding and help device manufacturers get to market faster.

Figures 1–3. PMA and 510(k) submissions were at or near five-year highs in 2011. Source: FY 2011 MDUFA Performance Report to Congress.

Medical device user fees were first authorized in 2002, under the Medical Device User Fee Modernization Act (MDUFMA I) for fiscal years 2003–2007. Now, under the amended MDUFA II, which is in effect through fiscal year (FY) 2012, FDA has committed to more stringent performance goals to improve the timeliness and predictability of medical device reviews. The two-tiered system divides performance goals based on short- and long-term review times (based on times previously established by MDUFMA I). This two-tiered approach is intended to ensure that a significant number of reports are completed in a shorter number of days by providing quantifiable goals.

FDA’s FY 2011 MDUFA Performance Report to Congress states that, based on preliminary data of completed and pending reviews, FDA has the met or has the potential to meet or exceed 17 of 21 Tier 1 performance goals and 15 of 21 Tier 2 goals. However, the report also shows that, despite these goals being met, the total time for review (FDA time combined with industry time) has been increasing. In her commissioner’s report, FDA commissioner Margaret A. Hamburg states that in January 2011 FDA announced a plan of action for improvement. Hamburg states the aim is to “create a culture change toward greater transparency, interaction, collaboration, and the appropriate balancing of benefits and risk; ensure predictable and consistent recommendations, decision-making, and application of the least-burdensome principle; and implement efficient processes and use of resources.”

The FY 2011 MDUFA report shows (Figure 1) that PMA, panel-track PMA supplement, and premarket report MDUFA cohort submissions reached the second-highest level in five years in 2011 (2010 being the five-year high). From FY 2008–2012, for nonexpedited filed submissions, 60% of decisions were issued on time for Tier 1, with this number increasing to 90% for Tier 2 (Figure 2). The number of 510(k) submissions under the MDUFA cohort portion (representing 94 of every 100 submissions) reached a five-year high in 2011 and decisions for 501(k)s were delivered 90% on time for Tier 1 and 98% for Tier 2 (Figure 3).

Overall, FDA has reported consistent year-to-year performance with regard to the expectations set by MDUFA II. However, FY 2012 marks the final year under the current amendment. Based on future performance and overall performance in FY 2008 through FY 2012, it will be interesting to see if FDA makes further revisions to create more lenient performance goals or perhaps to push itself further.

Goal	Tier	Performance Goals	Fiscal Year	Received	Pending Within Goal	Overdue	On Time	Percent On Time	Met Goal
Issue a decision for non-expedited Filed submissions	1	Issue 60% within 180 days	2008	33	0	12	21	64%	Y
	1	Issue 60% within 180 days	2009	41	0	9	32	78%	Y
	1	Issue 60% within 180 days	2010	54	7	12	35	74%	Y
	1	Issue 60% within 180 days	2011	42	28	3	11	79%	P
	2	Issue 90% within 295 days	2008	33	0	7	26	79%	N
	2	Issue 90% within 295 days	2009	41	0	6	35	85%	N
	2	Issue 90% within 295 days	2010	54	12	2	40	95%	P
	2	Issue 90% within 295 days	2011	42	30	0	12	100%	P

Performance indicators for FY 2008 through FY 2011 show that FDA has met, or is capable of meeting, performance goals for decisions issued for non-expedited filed submissions. Source: FY 2011 MDUFA Performance Report to Congress.

Goals	Tier	Performance Goals	Fiscal Year	Received	Pending Within Goal	Overdue	On Time	Percent On Time	Met Goal
Issue a decision for 510(k)s	1	Issue 90% within 90 days	2008	3310	2	208	3100	94%	Y
	1	Issue 90% within 90 days	2009	3444	1	357	3086	90%	Y
	1	Issue 90% within 90 days	2010	3224	72	303	2849	90%	P
	1	Issue 90% within 90 days	2011	3660	1697	104	1859	95%	P
	2	Issue 98% within 150 days	2008	3310	2	53	3255	98%	Y
	2	Issue 98% within 150 days	2009	3444	1	83	3360	98%	Y
	2	Issue 98% within 150 days	2010	3224	90	56	3078	98%	P
	2	Issue 98% within 150 days	2011	3660	1740	8	1912	99%	P

In 2011 510(k) decisions were delivered on time 90% of the time for Tier 1 and 98% of the time for Tier 2. ?Source: FY 2011 MDUFA Performance Report to Congress.

Performance Indicators	FY 07	FY 08	FY 09	FY 10	FY 11
BLA Supplements (CBE/CBE-30) – Percent Reviewed and acted on within 6 months	100%	100%	100%	100%	100%
IDEs – Percent of decisions made within 30 days	99%	99%	99%a	98%	100%
IDE Amendments – Percent of decisions made Within 30 days	98%	98%	99%a	99%	99%a
IDE Supplements – Percent of decisions made Within 30 days	99%	100%	99%	99%	99%
PMA Supplements (CBE) – Percent of decisions Made within 180 days	100%	100%	100%	_b	100%
PMA Supplements (135 day) – Percent of decisions Made within 135 days	100%	86%	100%	100%	100%
PMA Supplements (CBE - 30) – Percent of decisions Made within 30 days	100%	100%	100%	100%	100%


Percentages above 99%, but below 100% are Rounded down to 99%
b No PME (CBE) supplements were received in FY 2010

A review of FDA performance for submissions that do not have explicit MDUFA II performance goals. Source: FY 2011 MDUFA Performance Report to Congress.

Goal	Tier	Review Time	Performance Level FY 2008 – FY 2012 Submissions
Issue a decision for 180-day PMA supplements	1	180	85% on time
	2	210	95% on time

Shown is a summary of Tier 1 and 2 performance goals for 180-day PMA supplements. Performance goals are appllied to MDUFA cohort submissions. Source: FY 2011 MDUFA Performance Report to Congress.

—Chris Wiltz is the Associate Editor at MD+DI

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