Size Does Matter!

In a recent guidance issued by FDA entitled Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements (here), the Agency provides current guidance on the various aspects of proprietary and established names in advertising.

The document clarifies the relationship between the size (and not type size) of the proprietary name and established name in running text in advertisements and promotional material where the established name must be at least one-half the actual size of the proprietary name. 

AAM Letter to FTC – Issues Impacting Generic Access and Competition

The Association for Accessible Medicines (AAM) has penned a letter (here)  to the FTC, providing comments requested by that Agency relating to the Public Workshop held by FTC, Understanding Competition in U.S. Prescription Drug Markets: Entry and Supply Chain Dynamics, held  November 8, 2017 in Washington, D.C..

AAM (formerly the Generic Pharmaceutical Association [GPhA]) highlighted several areas of concern in their comments:

  • According to AAM,

FDA Provides Interesting Enforcement Information

FDA posted Donald Ashley’s, Director of the Office of Compliance (OC), presentation (here)   at the FDLI Enforcement, Litigation, and Compliance Conference presented December 6, 2017.  Mr. Ashley provided some interesting enforcement information, some of which is presented here.

The FDA’s Biomedical Monitoring (BIMO) program warning letters issued over the last 4 fiscal years is captured in the slide below.

New Metrics and Format for OGD Stats, Just Filled in For October 2017

The new statistical report of the Activities of the Generic Drug Program (FY 2018) Monthly Performance (here) was posted on December 4, 2017. There are many new statistics being captured and to tell the truth I am not sure exactly what they all mean but I think I’ve got it straight.  Please take a look at the above report and if you disagree with my reading on any of these metrics please give me a shout out.

November Another Big Month for OGD Approval Actions

Based on the FDA’s All Approvals list (here), by my count, it appears that November was another good month for FDA approval actions.  Looks like OGD will report at least (we know that until OGD publishes its official numbers, this is just an estimate) 84 full approvals and 15 tentative approvals for a total of 99 (just 2 less than last month’s all-time high monthly total of 101 during all GDUFA).

First Once-a-Month Buprenorphine Injection Approved

For the battle to fight opioid addiction and the so-called opioid use disorder (OUD), the FDA has given patients and practitioners another tool.  This once-a-month injection is indicated for OUD for patients on a stable dose of buprenorphine for at least 7 days.  Previous treatments with this drug required daily doses of orally administered products like films or tablets,

First Once-a-Month Buprenorphine Injection Approved

For the battle to fight opioid addiction and the so-called opioid use disorder (OUD), the FDA has given patients and practitioners another tool.  This once-a-month injection is indicated for OUD for patients on a stable dose of buprenorphine for at least 7 days.  Previous treatments with this drug required daily doses of orally administered products like films or tablets,

21 Page Response Again Confirms FDA’s Previous Position on ODE and H-W Exclusivity Carve-outs

Without going into a lot of detail, suffice it to say that the FDA has again rebuffed attempts to delay a 505(j) or 505(b)(2) version of a drug product protected by various periods of Orphan Drug Exclusivity  (ODE) and/or Hatch-Waxman (H-W) exclusivity, in a November 6, 2017 denial of a Citizen Petition from the innovator (here) .

Final Guidance on Abuse-Deterrent Opioid Generic Drug Testing Arrives – High Burden of Proof!

FDA published its final guidance on General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products (here) as perhaps a Thanksgiving present to the generic drug industry.  The theme throughout the document is “[i]f the summary in section 9.2 [of the RLD labeling] indicates that FDA has concluded that the product has properties that are expected to (or have been shown through postmarketing studies or trials to) deter abuse,

Stand Up and Take Notice

Well, in the dietary supplement battle for the erectile dysfunction (ED) market, it seems that FDA continues to find supplements that contain undeclared drugs.  In a public notification today, FDA advised consumers not to use yet another product for ED (see here).  As reported previously, it seems that FDA issues a few notices a month for products claimed to be dietary supplements,

Should an HBEL (Health Based Exposure Limit) be the Basis for Acceptance Values for Manufacturing Cleaning Validation?

The answer to the question of whether current cleaning validation limits generally in use in the industry (1/1000th of the minimum therapeutic dose of a drug product or 10 ppm) should be revised in favor of a Health Based Exposure Limit (HBEL) based limit was one of the major discussions at a “Workshop on the Generation and use of Health-Based Exposure Limits” held on 20-21st June 2017 at the European Medicines Agency.

Don’t Disregard Your OOS Rate

As stated in the FDA November 2016 draft Guidance, Submission of Quality Metrics Data – Guidance for Industry (here), one of the Quality Metrics that the FDA intends to monitor is the Invalidated Out-of-Specification (OOS) Rate (IOOSR).  The IOOSR quality metric is the number of OOS test results for lot release and long-term stability invalidated by the covered establishment due to an aberration of the measurement process divided by the total number of lot release and long-term stability OOS test results.