Applications Submitted During Shutdown Period and Acceptance Dates

FDA notes on its User Fee web page (here) that the key date for acceptance of NDAs, BLAs, and ANDAs will be dictated by the first date that FDA could accept fees under the appropriation (after the shut down was over) which is January 28, 2019.  The Agency gives the following advice as to how it will treat fee-paying applications and time periods for which fees must be paid (if not submitted at time of original submission of the application) (please see below):

  • For ANDAs transmitted to FDA during the lapse period,

FDA Draft Guidance – Notice of Marketing Status of NDAs and ANDAs

The Drug Price Competition and Patent Term Restoration Act of 1984 requires the FDA to publish a notice of all approved products and their marketing status.  The FDA satisfies this requirement by publication of the drug products in the Orange Book; the FDA will publish information in the active section (if the product is currently being marketed) or the discontinued section (if it not being marketed for other than safety or efficacy reasons).

Despite the Shutdown, January Approvals Look Fairly Strong.  Will FY 2019 Break Record?

With 5 working days left in January, and despite the turmoil this month has seen, we stand at 58 Full approvals and 17 Tentative approvals reported on the FDA All Approvals page (here) through January 24, 2019.

Looking at the first quarter approvals (October thru December), there were a total of 278 full approvals which,

FDA-Required Reports Hit the Web – What Does the Data Show?

Today, the FDA published its required Activities Reports of the Generic Drugs Program (FY 2019) – FDARA Title VIII, Sections 807 and 805 (here).  These reports are published quarterly, as required by law, and outline the following activities: ANDAs subject to priority review, ANDAs with a competitive therapy designation (CTD), and pending suitability petitions (a first-time report issued by the FDA).

Lachman Consultants Services, Inc. Announces Business Exposition Sponsorship of Access! 2019

While concluding its 40th Anniversary Celebration Year with the start of 2019, Lachman Consultants recently announced participation as Business Exposition Sponsor of ACCESS! 2019, the annual meeting of the Association for Accessible Medicines (AAM).

(Westbury, NY – January 2019) Lachman Consultant Services, Inc. a leading provider of expert compliance, regulatory affairs and technical services to life sciences clients worldwide will be a prominent participant at ACCESS!

Why December ANDA Receipts Were Not Reported – the Light Bulb Goes On

After thinking about our blog post yesterday (here http://www.lachmanconsultants.com/2019/01/the-20-day-window-catch-how-will-it-play-out-and-other-questions/), it now becomes clear why the update to receipts and approvals for the December posting of the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/abbreviatednewdrugapplicationandagenerics/ucm375079.htm) left out the number of December receipts.  It is because the FDA has not yet decided how to handle application receipts that came in after the shutdown on December 22,

The 20-Day Window Catch – How Will It Play Out? and Other Questions

The unprecedented length of the government shutdown has a lot of people scratching their heads about lots of things.  From a personal perspective, I have heard that FDAers are still getting paid (Commissioned Corps and civil servants) but the unknown is, for how long?  When will the user fee money really run out?  Has FDA been able to use the money that they collected for the applications submitted between October 1,

FDA User Fee Carryover Funds Dwindle as the Agency Tries to Keep the Boat Afloat

It will only be weeks until the User Fee carryover money for all the User Fee programs runs out. While Commissioner Gottlieb is doing his best to shuffle resources, the Agency will likely be up the perpetual tributary without any physical means of propulsion soon.

Because the Agency cannot accept any new fee-paying applications since the shutdown started,

Long Time Government/FDA Icon Bob West Passes Away

I woke up this morning to some sad news.  Bob West, former Public Health Service officer who spent some 40+ years in government service, passed away yesterday.  For those of you in the drug industry, the name Bob West meant a caring, rational, helpful individual.

Bob came to OGD after a stint with the Public Health Service’s hospitals and clinics and then after a number of years in New Drugs. 

Guidance on TA’ed Applications Deserves TA – Total Attention!

In an unusual move, the FDA posted a guidance document on its webpage describing how to handle tentative approvals titled “ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs” (here) prior to its announcement in the Federal Register with this accompanying note:

“We are posting this document on the FDA website as Federal Register (FR) publication is not currently available for this document.  

Official December 2018 Approval Numbers In – But What’s Missing?

OGD fully approved 69 original ANDAs and tentatively approved 31 for a total approval action of 100.  This is actually 18 more than we were able to spot on the FDA all approvals actions in our January 3rd post (here).  Not bad, considering the short month with vacations and the Federal government shutdown that started December 22 so actually represents a better result than what we anticipated.

Gottlieb Hints at Biosimilar Scare Tactics; Is There Any Surprise Here?

Shortly after the 1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman) was passed (the legislation that greatly expanded the universe for generic drug products), and even before the first generic under the new legislation was passed, a campaign was initiated to undermine the public’s confidence in generic drugs.  Major pharmaceutical companies began petitioning the Agency with frivolous claims that the system for determining bioequivalence was not sufficiently robust to clearly determine that a generic was truly therapeutically equivalent to its brand name counterpart.

Looking for Federal Register Notices? – Good Luck!

Attempts to access the Federal Register sites, where many of the pre-publications for important FDA business, regulatory actions, proposed and final rules and regulations, petitions and the like are published is met with the following notice:

Due to the shutdown of the Federal Government, National Archives facilities are closed, websites and social media are not being updated or monitored,

Big Year for NMEs at FDA

In 2018, the FDA says it approved fifty-nine new molecular entities, which included a whopping thirteen biosimilar products.  All of the NME product approvals can be found here.

It is important for you the read the FDA explanation of how the Agency is defining NMEs for the purposes of this report and stay focused on the regulatory implications versus the practical implications of how the FDA is classifying this term.