I wouldn't be at all surprised if FDA wasn't wishing much the same thing.
Original Message:
Sent: 07-Aug-2016 15:27
From: Dan O'Leary
Subject: enforcement discretion
I should have added that, as I understand the situation, the House Appropriations Committee does not have the legal authority to instruct FDA. It would require a law, such as we saw in FDASIA, which told FDA they must notify certain committees before taking action on LDTs.
Since the three branches of government are a coherent whole focused on the public’s best interest, FDA may have considered this as prudent advice and put the project on hold. I wish there were an easy way to find out.
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Dan O'Leary
Swanzey NH
United States
Original Message:
Sent: 07-Aug-2016 15:19
From: Dan O'Leary
Subject: enforcement discretion
Found It!!
There is a RAPS article posted December 24, 2015 By Zachary Brennan entitled Expectations for 2016: Drug Pricing, Biosimilars, LDTs, and More.
http://www.raps.org/Regulatory-Focus/News/2015/12/24/23837/Expectations-for-2016-Drug-Pricing-Biosimilars-LDTs-and-More/
It says, “FDA also expects to release its draft LDT framework in 2016.” and links to a December 20, 2015 blog from Hyman, Phelps, & McNamara entitled FDA Plans to Issue Final LDT Framework in 2016; Subcommittee Members, CMS, and FDA Officials Critique Proposed Legislative Approach that Would Give CMS LDT Premarket Review Authority.
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/12/fda-plans-to-issue-final-ldt-framework-in-2016-subcommittee-members-cms-and-fda-officials-critique-p.html
It says, “As 2015 draws to a close, the world of laboratory-developed test regulation continues in high gear. One major event featured the Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren testifying last month before the House Energy & Commerce Committee Subcommittee on Health. Dr. Shuren stated that the Agency intends to issue a final framework under which FDA would actively regulate LDTs in 2016, although he could not pinpoint when in 2016 the final guidance would be issued.”
Given that FDA-CDRH recently published the draft guidances on changes to 510(k) devices, I anticipate the final guidance documents on LDTs can’t far behind. (I will admit my stock market predictions, weather predictions, crop predictions, sunspot predictions, etc. are better than my FDA predictions.)
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Dan O'Leary
Swanzey NH
United States
Original Message:
Sent: 02-Aug-2016 00:04
From: Julie Omohundro
Subject: enforcement discretion
Dan, definitely no law. I went back through my emails and found an article in the June 2016 newsletter by a trade association, stating that the House Appropriations Committee had recently "gone on record, instructing the FDA to suspend efforts to finalize the LDT guideline, and allow Congress the necessary time to pass legislation that addresses a new pathway for regulation of LDTs." I think this is the most recent info I have.
Didn't mean to overstate the case, but it's no secret that the guidance has stirred up a good bit of controversy in Congress, and I'd be surprised if Shuren wants to issue a final guidance without knowing whether he's likely to have a budget to implement it. If he thinks it's on track for this year, my best guess would be he thinks Congress will come to some kind of decision this year.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 29-Jul-2016 06:37
From: Dan O'Leary
Subject: enforcement discretion
In discussing FDA’s regulation of laboratory developed tests, LDTs, you said, “Congress said, hold on a minute. So now Congress is mulling it over and the guidance is on hold.”
Can you explain this a little more? I know there has been some activity in some committees. However, I don’t know that Congress, as in a law, has said anything beyond FDASIA which required FDA to notify before issuing the draft guidance documents. FDA did that.
The last I heard some official in FDA, Dr. Shuren I think, said in a speech that the LDT guidance and the 510(k) guidance are on track for this year.
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Dan O'Leary
Swanzey NH
United States
Original Message:
Sent: 12-Jul-2016 18:26
From: Julie Omohundro
Subject: enforcement discretion
In means FDA gets to decide whether to enforce or not.
This term has been much in use lately related to laboratory developed tests. FDA recently announced that it has always had the authority to regulate LDTs, but until now it has exercised its enforcement discretion and not done so. Then it issued a draft guidance explaining how it planned to regulated LDTs going forward. Congress said, hold on a minute. So now Congress is mulling it over and the guidance is on hold.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 12-Jul-2016 13:54
From: Sheetal Pandya
Subject: enforcement discretion
What does "enforcement discretion" mean for IVDs?
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Sheetal Pandya
BSc, MS, RAC
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