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,

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!  

One-Time Report on Marketing Status Required by FDARA – Are You Ready?

After the glow of the holiday season, and after the big bowl games and national football championship, you better get the team prepared to file your one-time report of the marketing status of every one of your NDA and ANDA products.

FDARA requires every firm to submit the one time written report telling FDA if:

  1. the NDA or ANDA holder’s drug(s) in the active section of the Orange Book are available for sale;

Homeopathic Drugs- Home for the Holidays or Not?!

Those homeopathic drug products for which no determination that the product is a new drug may be marketed under the Federal Food Drug and Cosmetic Act.  However, given the current burgeoning homeopathic market, the FDA held a public hearing on March 27, 2015 to seek comments on its current regulatory framework for such products. “As a result of the Agency’s evaluation,

STIC it to Me! FDA Says, “You Have One Year to Do It”

The labeling for approved antifungal and antimicrobial prescription drug products contains certain language regarding the susceptibility test interpretive criteria (STIC) and associated test methods and quality control standards, with associated references for antimicrobial drugs for the specific compound.  Many approved drug products have been around for a long time and the information regarding the STIC in their labels are outdated. 

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. 

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.

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,

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. 

Compounding Pharmacies Still in FDA’s Crosshairs

From August 2016 to October 2017, FDA has issued 63 Warning Letters (an average of 4 per month) and has orchestrated 4 Injunctions and multiple prosecutions against Compounding Pharmacies and their Principals. Most of the Warning Letters deal with citations for insanitary conditions for compounding and for lack of sterility assurance for compounded preparations.

It is certain that FDA is continuing to apply pressure on this industry with no letup in sight.

Improving Health of the Least of Us for the Benefit of All of Us – A Guest Blog

My previous guest blog post, “Taking Care of Our Neighbors” (here), was focused on improving the health of uninsured, low income Americans, and the Dispensary of Hope’s incredible collaborative network.  Today, my mind is on the need for a change in our economic perspective as it relates to improving the health of our uninsured friends,