FDA DRUG SHORTAGE STATEMENT TARGETS HOARDING BY HEALTHCARE PROVIDERS

In an unfortunate twist, FDA is admonishing healthcare providers for hoarding behavior in the aftermath of Hurricanes Maria and Irma that devastated Puerto Rico and have contributed to ongoing drug shortages.  According to a recent statement from FDA Commissioner...

PHARMACY VP CHARGED IN PA DRUG RECYCLING DIVERSION SCHEME

Supply chain criminals who infiltrate pharmacies in order to perpetrate non-controlled prescription drug diversion schemes have had the upper hand for years.  The primary culprit behind this sobering reality is the historical lack of oversight from resource-strapped...

OUR AILING SUPPLY CHAIN NEEDS A PANGEA-STYLE FDA OPERATION OF ITS OWN

Operation Pangea X has received a lot of attention in the media, and rightly so.  Not only does this collaborative effort demonstrate a global resolve to protect patients everywhere from the insidious flow of counterfeit drugs and other illegal medical products...

PERFECT STRANGERS-DUE DILIGENCE AND THE DSCSA

Due diligence is an indispensable component of supply chain security, but it is largely non-existent in the Drug Supply Chain Security Act.  Its perceived presence in the law is widely misunderstood too, I believe.  Take, for instance, a just-released and quite...

NEW GLOBAL SUPPLY CHAIN SECURITY INITIATIVE ANNOUNCED BY FDA

Strengthening the global supply chain for medical products is a lofty goal and FDA is striving to make that a reality.  Yesterday, the agency trumpeted its leading role in partnering with Asia Pacific Economic Cooperation (APEC) economies to create a supply chain...

THREE PA PHARMACISTS TIED TO ILLEGAL FOREIGN-SOURCED DRUG CASE

Three pharmacists from Western Pennsylvania allegedly purchased wholesale quantities of illegal foreign-sourced drugs from an illegitimate Canadian supplier, and while we don’t yet know which pharmacies or drugs are involved, you can be certain more criminal charges...

RAMBO AND THE PUSH FOR DRUG IMPORTATION

Adding to the slew of recent articles on the drug importation issue, a just-released California Healthcare piece discusses a new proposal that would allow “not only individuals but drug wholesalers and pharmacies to buy from Canada.”  Undoubtedly, this is music...

FDA’S COUNTERFEIT DETECTOR (CD-3) AWARDED A PATENT

FDA’s groundbreaking handheld counterfeit detection device (CD-3) has been awarded a patent, according to a just-issued report by Securing Industry.  The question I have is why this process took so long.  This amazing device is relatively inexpensive and highly...

FDA ANNOUNCES SEVERAL DSCSA-RELATED GUIDANCE DOCUMENTS SLATED FOR 2017

FDA expects to issue nine DSCSA-related guidance documents this year, according to the agency’s just-released Guidance Agenda for 2017.  While most of these are holdovers from 2016, a few are new additions.  Specifically, all but the last three items below were...

FLORIDA ONCOLOGIST CONVICTED IN ILLEGAL FOREIGN-SOURCED DRUG CASE

A corrupt Florida oncologist who victimized vulnerable cancer patients under her care by exposing them to illegal, foreign-sourced medications is facing serious prison time.  D. Anda Norbergs was convicted by a federal jury yesterday on multiple misbranding,...

COLORADO NURSE ARRESTED IN CONTROLLED SUBSTANCE TAMPERING INCIDENT

A former nurse at the University of Colorado Hospital has been arrested for allegedly tampering with vials of pain medications intended for six patients, according to a recent report by The Denver Post.   Court documents referenced in the report stated Kacye Unruh...

NEW YORK PHARMACIST SENTENCED TO PRISON IN MASSIVE DIVERSION CASE

A New York pharmacist is headed to prison for his role in selling diverted HIV drugs worth over $274 million dollars (that’s not a mistake folks-a quarter of a billion dollars!). Ira Gross was sentenced earlier this week to 8 to 24 years in state prison,...

BLACK MARKET DIVERTER OF HIV DRUGS ARRESTED

If the Drug Supply Chain Security Act was intended to deter the exponential growth of prescription drug diversion and counterfeiting crimes over the last decade, someone forgot to tell Robin Deleonrosa, who was recently arrested for his role in a $1.9 million black...

THE TIME HAS COME FOR FDA TO ADOPT A MORE COMPREHENSIVE CD-3 STRATEGY

It’s been almost three years since FDA announced plans to deploy its ground-breaking handheld counterfeit detection device (CD-3) in Ghana to aid in combating the insidious counterfeit and substandard malaria medicine problem in that region (see my previous posts on...

COUNTERFEIT-DEALING CHICAGO PHARMACIST SENTENCED TO PRISON

A counterfeit-dealing Chicago pharmacist has been sentenced to prison and will forfeit his pharmacy after pleading guilty last year to counterfeit drug charges (see here). Michael Markiewicz admitted to illegally purchasing counterfeit versions of Viagra and Cialis...

CHINESE CHEMICAL FACTORY LINKED TO FRAUDULENT SUPPLEMENT CASE

A recent criminal case once again underscores that undisclosed chemical ingredients potentially lurking inside fraudulent dietary supplements promoted for sexual enhancement, weight loss, and bodybuilding remain a serious risk to the health and safety of American...

FDA SET TO ISSUE SIX DSCSA GUIDANCE DOCUMENTS IN CY 2016

On January 22, 2016, FDA announced its list of new and revised draft guidance documents that CDER is planning to publish in calendar year 2016. Included in this list are the following six DSCSA-related documents (see p. 4/Procedural Category): 1. DSCSA Implementation:...

FDA ISSUES SECOND DSCSA EXTENSION TO DISPENSERS

FDA has issued a second compliance extension to dispensers, giving this group of trading partners even more time to meet the DSCSA’s product tracing requirements that were originally set to take effect on July 1, 2015. FDA’s initial compliance policy, issued on July...

TAINTED DIETARY SUPPLEMENTS-AN INEVITABLE PUBLIC HEALTH DISASTER

Since March 2007, FDA has notified the public a total of 662 times about potentially dangerous dietary supplement products marketed for sexual enhancement, weight loss, and muscle building that were found to contain hidden drug ingredients (see here). In 2015 alone,...

NEW YORK WHOLESALE DISTRIBUTOR TIED TO NATIONWIDE DIVERSION SCHEME

A recently-issued U.S. Department of Justice (DOJ) press release reinforces yet again the urgent need for state and federal regulators and law enforcement authorities to ramp up their efforts to identify and aggressively pursue corrupt wholesale distributors that...