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On January 22, 2016, FDA announced its list of new and revised draft guidance documents that CDER is planning to publish in calendar year 2016.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...

A NUMBERS DRIVEN PERSPECTIVE ON SUPPLY CHAIN SECURITY

Any law, no matter how well-intentioned or deftly crafted, will ultimately miss its mark without the requisite resources in place to ensure compliance. This is best described by the oft-used speeding analogy. Legislators can require the posting of speed limit signs at...

APOLLO CREED’S SOLUTION TO SUPPLY CHAIN SECURITY

In one of the first criminal convictions of its type, two companies pled guilty for failing to provide pedigrees. Can you guess the year? No, it wasn’t 1988, the year President Reagan signed the PDMA into law. Not even 1998, a decade later. If you guessed 2004, a...

THE PROBLEM WITH ILLEGITIMATE PRODUCT DETERMINATIONS UNDER THE DSCSA

The requirement for wholesaler distributors, dispensers, and repackagers to coordinate illegitimate product determinations with manufacturers is a relatively minor aspect of the Drug Supply Chain Security Act, but one that has the potential to cause some serious...

MASSIVE $400 MILLION PRESCRIPTION DRUG DIVERSION SCHEME ANNOUNCED

A massive prescription drug diversion scheme spanning 2007 through April 2014 and totaling nearly $400 million in total sales was the subject of recent U.S. Department of Justice press release, dated May 7, 2015. David Miller, his Eagan, Minnesota based wholesale...

STILL WAITING FOR FDA’S NATIONAL DATABASE OF WHOLESALE DISTRIBUTORS

FDA is keeping us waiting. It’s long-anticipated (at least by me) national database of authorized wholesale distributors, mandated under the Drug Supply Chain Security Act to be established by January 1, 2015, has yet to make an appearance on the public stage. Maybe...

COMING SOON- FDA’S DATABASE OF WHOLESALE DISTRIBUTORS

FDA’s long-overdue database of licensed wholesale distributors should be unveiled soon. Although the Drug Supply Chain Security Act required FDA to establish this database by January 1, 2015, the agency’s web site indicates it will be coming in the future. Most...

WEST VIRGINIA PHARMACY OWNER PLEADS GUILTY IN HEALTHCARE FRAUD CASE

Another federal prosecution involving a corrupt pharmacist is once again adding to concerns that rogue pharmacists and pharmacy owners are thriving amidst an under-regulated and vulnerable pharmaceutical supply chain. Unfortunately, as history has shown, patients will...

FORMER PHARMACY CEO PLEADS GUILTY IN MASSIVE DRUG DIVERSION SCHEME

The former CEO of a Michigan pharmacy is facing up to 10 years in prison after pleading guilty for his role in a massive prescription drug diversion scheme totaling 18 defendants, including 6 licensed pharmacists, and more than $80 million in insurance payments for...

TAINTED DIETARY SUPPLEMENTS-A CONTINUING PUBLIC HEALTH MENACE

Fraudulent products marketed as dietary supplements are a continuing public health menace. These products, predominantly sold for sexual enhancement, bodybuilding and weight loss are likely to be the cause of our next public health catastrophe, possibly exceeding the...

THE ALARMING DECREASE IN FDA REGISTERED OUTSOURCING FACILITIES

In a July 2014 post, I commented on what appeared to be a very low number of outsourcing facilities that had registered with FDA under section 503B of the FD&C Act. At the time of that post, the number was 48. Since then, it has fallen to 37, an alarming decrease...

FATHER AND SON PHARMACISTS SENTENCED TO PRISON

A father and son duo of pharmacists has been sentenced to prison for their roles in operating separate drug diversion schemes from a Boston, Georgia pharmacy. This criminal case is yet another alarming reminder that suboptimal pharmacy oversight is critically...

THE DSCSA AND DUE DILIGENCE-BUELLER? BUELLER? BUELLER?

When I think of due diligence and the Drug Supply Chain Security Act, I’m reminded of that memorable scene from Ferris Bueller’s Day Off.   Ben Stein, who played Bueller’s economics teacher, repeatedly calls his name when taking attendance, even though he’s not...

THE DSCSA AND SALEABLE RETURNS-A KEY SUPPLY CHAIN VULNERABILITY

It’s probably safe to say that many new laws, however well-intended, are not perfect.  The bad guys are highly motivated, often undeterred, and eventually find ways around them. You build a fence, they build a bigger ladder. Such is the case with the Drug Supply Chain...