New Footnote Raises Questions About Approval Numbers

As I was reviewing the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here) as I do a few times a month, I came across a new footnote to the report.  It reads:

++++ = FY19 Approval and Tentative Approval counts were updated in April 2019 to better reflect program output by capturing all approval actions on original applications,

Patiotic cowboy boots

Consumer Antiseptic Rubs Final Rule – or Is It?

Publishing tomorrow, the FDA will announce that 28 ingredients that were considered in the June 30, 2016 proposed rule were given the boot while further consideration of three ingredients (benzalkonium chloride, alcohol (also referred to as ethanol or ethyl alcohol), and isopropyl alcohol) were deferred until the firms had more time to conduct appropriate studies and the Agency has time to review the additional information to be submitted. 

Back view business woman raising hand for asking speaker for question and answer concept in meeting room for seminar

OBSERVATIONS AND INSIGHTS FROM ISPE 2019

As always, Lachman Consultants looks to provide excellence in all phases of serving our clients’ needs, so we paid close attention to the various speakers, panels and general goings-on at the 2019 ISPE Europe meeting to take the pulse of the industry.  We also spoke to many of the show’s attendees, and the takeaways from our many observations and conversations covered a variety of topics.  

March Official Approval Numbers and Receipts Are in – We Were Close!

March 2019 actually saw 89 full approvals and 17 tentative approvals for 106 approval actions (our predictions were off by one).  This is another good month for ANDA approvals, but it is also a month that saw the largest number of ANDA submission for FY 2019 at 118.  We believe this corresponds to the end of the fiscal year for India,

Bioanalytical Workshop Generates Question on FDA vs. ICH Guidance

The 13th annual WRIB (Workshop on Recent Issues of Bioanalysis) was held in New Orleans, LA this week and is wrapping up today.  The workshop was well represented by regulators and industry (both from Pharma and CROs), with numerous discussions and topics for the bioanalysis of small and large molecules.  Presentations covered the full spectrum of bioanalysis from recently issued guidance documents (both draft and final),

Gottlieb’s Parting Message on Compounding – Priorities for 2019

As the FDA and industry prepare for Dr. Gottlieb’s departure from the FDA tomorrow, he and Deputy Commissioner Anna Abram issued a statement (here) on the FDA’s 2019 priorities to improve the quality of compounded drugs.  As the statement notes, compounded drug products are not FDA-approved and, thus, can pose a serious threat to the public if not prepared properly. 

FDA Blasts Shots Over the Bow to Four Homeopathic Firms for CGMP Violations

 

In the not-too-distant past (April 2015), the FDA held a public hearing on potential changes to the enforcement policies and the regulatory approach associated with the marketing of homeopathic drug products.  The FDA indicated that it has not had a comprehensive review of the enforcement policies related to these products to reflect changes in the homeopathic market in over twenty-five years (twenty‑seven years now).  

March 26th a Big Day for Tadalafil – 15 ANDAs Stand Up to Be Counted

The 15 approvals for the generic of Cialis come on the day of the expirations of the 180-day exclusivity enjoyed by the first-to-file applicants.  Assuring that the ANDAs gain approval on the first legally possible date that they can be approved means that the price will go down and, when 15 ANDAs receive approval, the price decrease should be substantial.

Dietary Supplements – Using Contract Manufacturers

 

As many dietary supplement marketers are essentially virtual companies, all manufacturing and testing is performed by organizations contracted by the marketer.  In the ten years or so since the dietary supplement GMPs went into effect, control of these contractors has been an ongoing challenge.  Most dietary supplement marketers have demonstrated adequate control over their contractors,

Young woman with a flat tire

ANDA Suitability Petitions: The Way Back to Normalcy (and Some Sanity)

Coauthored by Kurt Karst (of FDA Law Blog) and Bob Pollock

The “Petitioned ANDA”—It’s a route to ANDA approval that’s been around since even before the enactment of the 1984 Hatch-Waxman Amendments.  For several years after the enactment of Hatch‑Waxman, the petitioned ANDA was a mainstay of the generic drug industry’s drug development paradigm.  

Approval Time Data Won’t Look Good Until the Oldies Are Cleared Out

Every day, when I look at the ANDA approvals list, I see that most of the approvals are for the older ANDAs that were submitted to OGD before Year 4 of GDUFA I (when goal dates started).  Some of these applications are anywhere from six to ten years old.  Once they receive approval, they have a “negative trend” on the mean and median time to approval reported by the FDA. 

Halfway Through March – OGD on Pace for Ninety Approval Actions

With numbers reported to date through March 15th,  it looks like the OGD will reach ninety approval actions this month.  There have been thirty-eight full approvals and seven tentative approvals reported so far this month.  With the OGD averaging eighty-eight full approvals for the first five months of FY 2019, it will need to push to get to that number by the end of the month,