Regulatory Open Forum

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  • 1.  enforcement discretion

    Posted 12-Jul-2016 13:55

    What does "enforcement discretion" mean for IVDs?

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    Sheetal Pandya
    BSc, MS, RAC

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  • 2.  RE: enforcement discretion

    Posted 12-Jul-2016 18:27

    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  Then it issued a draft guidance explaining how it planned to regulated LDTs going forward.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



  • 3.  RE: enforcement discretion

    Posted 29-Jul-2016 06:38

    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don’t know that Congress, as in a law, has said anything beyond FDASIA which required FDA to notify before issuing the draft guidance documents.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



  • 4.  RE: enforcement discretion

    Posted 02-Aug-2016 00:05

    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



  • 5.  RE: enforcement discretion

    Posted 07-Aug-2016 15:20

    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



  • 6.  RE: enforcement discretion

    Posted 07-Aug-2016 15:27

    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



  • 7.  RE: enforcement discretion

    Posted 08-Aug-2016 13:53

    I wouldn't be at all surprised if FDA wasn't wishing much the same thing.

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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



  • 8.  RE: enforcement discretion

    Posted 08-Aug-2016 13:52

    Dan, thanks for taking the time to track this down.

    Ah well, you know...the new EU device regulations were first "expected to be" released three years ago, then every six months thereafter, and I personally would not bet a large sum that they will be signed and sealed by the end of the year.

    It seems that Regulatory and crystal balls are a poor mix!

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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



  • 9.  RE: enforcement discretion

    Posted 13-Jul-2016 08:11

    Hi Sheetal.

    I tend to think of "enforcement discretion" in more general terms than just as relates to a particular product or product class.  It is essentially an age-old problem - too many rules, too many products, too few person-hours to deal with them all.  So effectively "enforcement discretion" becomes a way to prioritize issues such that inspectors and staff know what FDA management believes to be the most important problems to deal with.  This is also not specific only to FDA - it happens quite literally in every single one of the Executive branch offices in the US because again, no one has enough personnel to deal with the entire spectrum of small to huge problems.

    So, as Julie noted, FDA did "decide" that they had sufficient personnel to lift their moratorium on things like LDTs which the FDA has considered itself to have had authority over and taking a position that such testing was something they didn't have the staff to manage nor did the testing seem to be all that controversial.  Now, the FDA considers (after some very high-profile issues arose in the LDT industry) that these issues are more important/more severe than they originally expected or have become more important/more severe in terms of the information provided to the individual that has been erroneous at best.  So they began the process of describing how they are going to manage these tests - in the form of a draft guidance.  And as Julie noted, Congress stepped in (seemingly rather quickly considering the partisanship in Congress) to basically tell FDA to put a hold on the whole thing.

    So if you look at the idea - essentially enforcement discretion means that FDA (or any Executive branch agency in the government) has made a decision that your product is not sufficiently problematic for them to utilize significant personnel assets that are limited to begin with on your problems or issues.

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    Victor Mencarelli
    Sr. Manager - Regulatory Affairs
    Hain Celestial Group
    United States



  • 10.  RE: enforcement discretion

    Posted 13-Jul-2016 09:35
    Edited by Andrea Chamblee 13-Jul-2016 09:38

    There is a centuries-old legal principle that "de minimis non curat lex," or "the law is not concerned with trifles," also interpreted as "a judge can't fix everything." It means not every violation requires a court filing, either criminally or civilly. Law enforcement can't be unfair to a "protected class" (race, for example), and an agency can't be "arbitrary and capricious." However, it can use a case to set an "example," and it can decide not to prosecute at all.

    The criminals who separately distributed salmonella-tainted eggs and peanut better recently argued, among other things, that the Agency unreasonably exercised its enforcement discretion against them; they lost.

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    Andrea Chamblee Esq., RAC, FRAPS

    This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

    Silver Spring MD
    United States