Transparency for Decision-Making Process Coming to an Inspection Near You!

In June of 2017, FDA released a document entitled “Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations.”  This white paper/concept of operations (ConOps) reviews the coordinated operational efforts between the Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA).

The anticipated outcomes of the operating model will enable FDA to meet new challenges presented by the complex pharmaceutical industry intricacies. 

AAM Testifies at Opioid Hearing

Today, the AAM is providing written testimony to the Committee on Energy and Commerce Subcommittee on Health addressing Combating the Opioid Crisis: Prevention and Public Health Solutions, the full text of which can be accessed through the AAM website (here ).

The testimony addresses the following major points.

  • It is critical that we combat the misuse of prescription medication while maintaining legitimate,

March Shows Increased Pace of ANDA Approvals

Since January 2018, the number of ANDA approvals has slowed dramatically.  In the first three months of FY 2018 (beginning in October 2017), ANDA approvals were averaging 83 a month. The monthly average for January and February was 28.5.

We know that the slowdown in approvals was due in large part to the change in documentation requirements for elemental impurities (EI) in all applications. 

OGD First-Time ANDA Approvals for 2018 and What They May or Not Mean to Consumers

Even though the slowdown in ANDA approvals, attributable to the issues of elemental impurities, has dampened the first two month of 2018 (here),  the number of first-time generic ANDA approvals seems to be higher than would be expected.  FDA reported 10 first-time generics (note that there may be multiple reports for the same drug if multiple applicants obtain approval on the same day) through March 8,

OGD Dashboard Sheds Current Light on Workload

The Office of Generic Drugs (OGD) posted its updated Dashboard for ANDA workload activity on Friday.  The new posting is current through the first quarter of FY 2018 as of January 1, 2018.

Original ANDA Activity for Pre-GDUFA Year 3 Application Cohort

Total Original ANDA Workload Activity for All Unapproved Applications


Flu the Coop!

Even with this season’s flu season past its peak, FDA is warning consumers about potential fraudulent product touted as curing or lessening the flu.  The FDA health fraud alert (here) warns consumers to be aware of fraudulent product claiming to treat, prevent, or lessen flu symptoms.  In addition, they also warn patients to be wary of online pharmacy sites that may offer unapproved or fraudulent anti-viral products.

US FDA Guidance – Good Clinical Practice: Integrated Addendum to ICH E6(R1)

The US FDA just released their Guidance for Industry titled “E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)” (here).  The guidance provides a path forward for the mutual acceptance of clinical trial data across regulatory authorities from Canada, the European Union, Japan, Switzerland, and the United States.

The guidance clearly identifies the added revisions,

Defining Suspect and Illegitimate Products Under the Drug Supply Chain Security Act (DSCSA)

The FDA has issued a guidance (here) that provides clarification on the definitions of suspect and illegitimate products under the  Drug Supply Chain Security Act (DSCSA).  The definitions are designed to help those in the supply chain better and more accurately characterize problem products they may uncover.

The guidance provides the following definitions:

SUSPECT PRODUCT—The term ‘suspect product’ means a product for which there is reason to believe that such product —

(A) is potentially counterfeit,

Maybe There is a Reason After All!!

Getting back to the elemental impurities (EI) issue, we received additional interesting feedback from one ANDA sponsor.  They said sometimes “this stuff gets tricky.”  The sponsor related a situation of a capsule ANDA product that could be administered multiple times a day at high maximum daily dose.  The empty capsule shell had the standard limit for lead;

Compounding Fairness???

As the compounding Industry awaits the next round of Guidances from FDA on using bulk drug substances, one point of controversy appears to be the fairness of compounding for 503A and 503B entities. The most recent Guidances for Compounding from Bulk Drug Substances are:

Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food,

Interesting Feedback on Elemental Impurities

After my post on Thursday (here) regarding the slowdown in ANDA approvals because of lack of documentation of elemental impurities, and my assumption relative to NDA applicants, I received some interesting feedback from two NDA applicants.  I was told that the New Drug Division would not hold up issuing an approval action letter if the only issue was that of elemental impurities,

FDA Warns of Potential Harm with Using Clarithromycin in Patients with Heart Disease

The new warnings which FDA says will be incorporated into both clarithromycin’s brand (Biaxin) and generics labeling come after review of a number of long-term studies revealed an increased risk of death in patients with preexisting coronary disease.  The interesting finding is that the risk is not necessarily immediate, but can occur in patients with preexisting heart disease years after taking the drug.