Join former FDA Investigations Branch Director Ricki Chase – now with Lachman Consultants – as she draws on her 16 years of agency experience to bring you the latest insights into the complexity surrounding combination device/drug products.
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.
Here we are on January 29th and so far this month, there have been only 12 ANDAs approved and one tentative approval which have been posted on FDA daily approvals list. This month, January 23rd tops the number of approvals with 3 approvals listed. In previous months, we have seen as many as 11 approved on a single day.
Just days after FDA Commissioner Dr. Scott Gottlieb shared the 2018 Compounding Policy Priorities Plan, FDA issued three guidances:
There is a big buzz about a new player in town but not a lot of information on how it plans to operate. Drug Store News reports “There will soon be a new generics manufacturer to contend with — one that comes with a built-in base of 450 hospitals. Four major health systems — Salt Lake City-based Intermountain Healthcare,
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.
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.
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,
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.
The FDA announced today that they are revising labeling to remove any indication for codeine or hydrocodone-containing cough cold products for use in patient under the age of 18. The FDA Safety Communication (here) states:
“We are taking this action after conducting an extensive review and convening a panel of outside experts.
Here it is, 11 days into January 2018, and so far this month (at least at the last check this morning) OGD had approved only two ANDAs. Could it be that they pushed so many out in the first quarter of FY 2018 that there were none left to cross the finish line in early January,
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,
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.
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 – 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.
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!