Is There a New Tactic for Generic Manufacturers to Use to Hit a Bullseye?

We have long heard arguments that traditional and Outsourcing compounding entities represent unfair competition to the generic drug industry and that they frequently circumvent the Federal Food, Drug and Cosmetic Act (especially the 2013 Drug Quality and Security Act, DQSA).

A new tactic that has been recently used by a generic firm to protect its approved product was to sue FDA on the grounds that the FDA Interim Policy on compounding using bulk drug substances (APIs) under section 503B of DQSA is contrary to law. 

Macro photo of tooth wheels with COMPLIANCE, REGULATIONS, STANDARDS, POLICIES and RULES words imprinted on metal surface

Thought FDA Was Tempering Back Its Oversight and Enforcement of Compounding Operations? Think Again!

Commissioner Dr. Scott Gottlieb shared FDA’s 2018 Compounding Policy Priority Plan (here) providing an overview of the Agency’s key priorities to implement (and enforce) the federal law on compounding (Drug Quality and Security Act [DQSA], signed into law November 2013). He also states that this plan advances FDA’s mission to protect the health and safety of the public.

Future Green Road Sign Over Dramatic Clouds and Sky.

Guidance Agenda New & Revised Draft Guidances CDER Plans to Publish During Calendar Year 2018

FDA listed 106, either new or draft and/or revised draft guidances that it plans to issue in CY 2018.  This is quite an ambitious agenda!  This is a yearly exercise that FDA does and they have a tendency to come close to meeting their projections; be sure to review the entire list (here) to see if some of your interests will be met or augmented by some additional Agency guidance.

A fortune teller sitting at a desk gesturing at a glowing crystal ball. The bald man with the long beard

Elemental Elements Appear to Sink January Approvals

On January 11, 2018, we went out on a limb prognosticating that the very low numbers of ANDA approvals in January might be linked to a new USP requirement on documentation of elemental impurities that went into effect January 1st (see post here).  Since that time, the number of approvals has jumped from 2 to 4 (as posted on the FDA All Approvals site [here] through January 16th) but,

From Big Data To Cybersecurity, Today’s Device-Makers Face Myriad Compliance Risks – But Being Proactive Can Pay Off, Ex-FDA Official Says – article in Medtech Insight by Lachman Consultants

Too many medical device manufacturers are struggling because they don’t have policies and systems in place to handle the ever-growing amount of data they receive about their products once they’ve gone to market. As a result, important signals can go undetected or unaddressed, leading to compliance problems and devices that are of poor quality – both of which could ultimately affect a device-maker’s bottom line.

Never on Sunday!?

The proverbial title of a 1962 hit song by Petula Clark is something that piqued my curiosity today.  And yes, I am that old (I was 13 when that song came out and I loved to play with my pet dinosaur).  Anyway, I digress!  The reason I bring up “Never on Sunday” is, because, as I flip through the FDA’s All Approvals list,

Anticipating trends in regulation – how do you get your information, and what do you do with it once you do?

In today’s global marketplace, industry is responsible for adhering to regulations in all markets that their products are in. Today’s pharmaceutical supply chain also likely contains partners that are across many geographic regions, and regulators expect conformity. In addition, regulators expect proactive compliance, and concerns about a retroactive “lack of assurance” of GMP are frequently the cause of a recall. 

First Quarter FY 2018 ANDA Approvals, Receipts and More!

Well, the first quarter of approval actions for original ANDA and receipts are in the books.  We reported late last week that OGD fully approved 78 ANDAs and tentatively approved 19 ANDAs in December – well, we were as close as we ever have been, estimating using numbers derived from various FDA statistical reports… and the official numbers for November 2018 are – 78 full ANDA approvals and 20 ANDA tentative approvals for a total of 98 approval actions. 

DUE FEBRUARY 14, 2018 – One-Time Report on Marketing Status Required by FDARA- Don’t Forget!

To reiterate our post of December 27, 2017 (here), please start working on your one time report on the marketing status of your products listed in the Orange Book.  The deadline is approaching and FDA even republished its advice to industry (here) again today!

Don’t be left without a retort – be sure to submit your report!