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. 

OGD November 2018 Stats Updated

Despite the shutdown, it appears that the OGD is still pumping out ANDAs and updating required statistical metrics as it chugs along under what must be stressful conditions.

November 2018 (Month 2 of FY 2019) showed just four ANDAs received refuse-to-receive actions (four for standard ANDAs and one for a priority ANDA.  The OGD acknowledged ninety ANDAs and of the ninety‑nine approved ANDAs in November,

Approvals Actions for December 2018 won’t be a December to Remember

With the holidays, vacations and the partial government shutdown, OGD did not do too badly, with total approval actions of 82 and still a workday to go (and there are always those pesky approvals or tentative approvals that show up after the final bell).  This looks to be one of those “down months” that Cook talked about (I might add there have not been many of them recently),

Linaclotide Guidance Leaves BE Study with Clinical Endpoints as One Option but Also Provides for In Vitro Option as Well

Linaclotide capsules are “minimally absorbed with negligible systemic availability following oral administration.  Concentrations of linaclotide and its active metabolite in plasma are below the limit of quantitation after oral doses of 145 mcg or 290 mcg were administered.  Therefore, standard pharmacokinetic parameters such as area under the curve (AUC), maximum concentration (Cmax), and half-life (t½) cannot be calculated.”  Its site of action is locally in the bowel and intestines. 

Happy Holidays from Us to You!

To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year.  The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as we follow the ever-changing landscape of FDA regulatory science,

Ricki Chase Publishes Article in MedTech Insight

Ricki Chase, Director, Compliance Practice, authored an article published in Medtech Insight, “How Device Makers Can Leverage FDA Data to Uncover The Agency’s Current Thinking on Compliance”. In this article, she discusses how manufacturers can use information available online from inspectional observations, warning letters, and product recalls to ascertain FDA’s priorities with regards to compliance and enforcement actions.

Get the Government into the Manufacture and Distribution of Generic Drugs – Who Thought This One Up?

It looks like Senator Elizabeth Warren thinks it is a good idea! (see here!)  I think it is poppycock!  Just think of the problems we have now with drug shortages and recalls.  The stringent nature of the cGMPs and pharmaceutical manufacturing, in my opinion, do not lend well to government intervention.  What a conflict of interest the FDA Office of Regulatory Affairs would have in inspecting the government manufacturing operations!

FDA Publishes a Bonanza of Regulatory Documents on Biotech Products – a Deeper Dive

Many thanks to the FDA for publishing several important new and revised guidances and a proposed rule related to the Biopharmaceutical industry this week.  These include a finalized version of the “Deemed to be a License” Guidance for industry (here) with several important revisions and additions relative to the previously published draft,