Gridlock Jeopardizing FDA User Fees?

I babbled about MDUFA in July.  I likened MDUFA to the movie Lion King, in which case this story is about Scar leaving Simba to die.

The readers digest version is that MDUFA is Medical Device User Fee Amendment. It is a way for fees to be collected to fund FDA reviewing medical devices. This summer's version of MDUFA put some time tables on the FDA reviews. In simple terms the idea is industry pays a fee to fund reviews of devices and the FDA has a clock running to do those reviews.

Why does it matter in diabetes land? When and if there is a requirement for BG meters to be +/- 15% the regulatory review of those new meter will be funded by fees paid by industry and the FDA will do the reviews timely. PWD get more accurate meters. Yay.

Maybe not. 

Mass Device reports on a Bloomberg Newsweek story (sorry I haven't found that Bloomberg/NW piece yet) that the deal may be in trouble due to congress's in ability to act on the budget. The FDA can't spend the user fee money without trigger funding from Congress.

From MassDevice.com

The $610 million deal between the FDA and the medical device industry is in jeopardy as Congress dithers over the federal watchdog agency's budget, meaning that product reviews for devices and drugs could slow or even grind to a halt, according to Bloomberg BusinessWeek. 

That's because the FDA can't spend a dime of the user fee money until it receives trigger funding from Congress, an FDA spokeswoman told the news service. With Democrats and Republicans perpetually at odds on Capitol Hill, this time over a proposed $1.2 trillion in budget cuts over the next decade, that all-too-familiar Beltway stasis "could result in the loss of whole user fee programs, programs that have become essential to public health and medical product innovation," the spokeswoman wrote in an e-mail.

More: https://www.massdevice.com/news/medical-devices-fdas-user-fee-deal-rocks

MDUFA III - The Summer Sequel

Hollywood is all about summer block busters. Often these are remakes or spinoffs. So Batman Rises again, Spiderman get a new look and there are More Men are in Black. A less well know franchise just inked a renewal. Even more surprising is the group who produced it - Congress. It is called MDUFA III. It is a sequel. 

You may not be very familiar with MDUFA. I mistakenly call it Mustafa or Medusa regularly. It isn’t a Lion King or a monster of myth with snakes for hair. MDUFA is DC speak for Medical Device User Fee Amendment is part of the regulations that fund and manage the FDA. Some wags may content that means it is a scary monarchical monster but is isn’t.

If you live with a chronic condition that is managed with medical devices you should probably know a little about MDUFA. It started in 2002. (1) It allows for industry to pay fees that fund the FDA. These fees help pay for the review of medical devices. These fees were a means of preventing a backlog of device and drug approvals by funding FDA staff to review applications. 

The review that was just signed into law also creates performance goals for the FDA review process with outside third party review of the FDA’s pre-market approval (PMA) process, meeting these goals. The goal are: 

• For submissions received in FY 2013, FDA will issue a MDUFA decision for 91% of 510(k) submissions within 90 FDA Days.
• For submissions received in FY 2014, FDA will issue a MDUFA decision for 93% of 510(k) submissions within 90 FDA Days.
• For submissions received in FY 2015 through FY 2017, FDA 

To put that into a diabetes perspective the International Organization for Standardization (ISO) 15197 standard that specifies that, for a blood glucose level of below 75 mg/dl, the monitor reading must be within 15 mg/dl of the reference reading and, for readings of 75 mg/dl or higher, the monitor reading must be within 20% of the reference reading in 95% of tests. (2) So starting in October 2012 the FDA will ave tighter response time goals that our meters have accuracy goal. Yes I know that is a bogus comparison but what matters is there are goals to turn around device applications. Those goals get tighter with time. 

I will concede that MDUFA is not as exciting as a summer action movie and it may take longer to read the entire legislation than a film takes to watch. That said I am happy to see this action taken by Congress before the summer is over and election year politicking get in the way of progress. 

Notes:

(1)  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109105.htm

(2) International Organization for Standardization. In vitro diagnostic test systems—requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. 2010. Mar 20, ISO 15197:2003. http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=26309 Accessed.